Adult B Cell ALL, B-cell Lymphoma, B-cell Malignancy, Non-Hodgkin Lymphoma
Conditions
Keywords
CAR T, Non-Hodgkin Lymphoma, NHL, Lymphoma, Allogeneic, Leukemia
Brief summary
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
Detailed description
The study may enroll up to 227 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Interventions
CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
Sponsors
Study design
Eligibility
Inclusion criteria
Key Inclusion Criteria: 1. For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years 2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate renal, liver, cardiac and pulmonary organ function 5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX110 infusion. Key
Exclusion criteria
1. For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD. 2. History of central nervous system (CNS) involvement by malignancy 3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. 4. Presence of bacterial, viral, or fungal infection that is uncontrolled. 5. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection. 6. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years. 7. For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion. 8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | Up to 28 days | A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment \[e.g., 1 mg/kg/day\], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours. |
| Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population | Up to 5 years | The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | Up to 5 years | Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation. |
| Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | Up to 5 years | Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation. |
| Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | Up to 5 years | A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment. |
| Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population | Up to 5 years | The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method. |
| Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24 | Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level. |
| Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2 | Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion. |
| Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | Up to 5 years | An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment. |
| Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Up to 5 years | Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities. |
| Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | Up to 5 years | Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation. |
Countries
Australia, Canada, France, Germany, Spain, United States
Participant flow
Recruitment details
The study comprises 4 cohorts: Cohorts A, B, and C enrolled adult participants with non-Hodgkin lymphoma (NHL); Cohort D enrolled participants with adult B cell acute lymphoblastic leukemia (ALL). A total of 93 participants were enrolled; 3 participants died prior to receiving CTX110 (1 due to pulmonary haemorrhage that occurred after lymphodepleting \[LD\] chemotherapy but was assessed as not related to LD chemotherapy, and 2 due to disease progression).
Pre-assignment details
The study was designed to be divided into 2 phases. A total of 8 participants were enrolled in the Phase 2 dose expansion. Due to a high proportion of non-quantifiable values, the secondary efficacy endpoints for Phase 2 participants could not be calculated. The study was terminated early in Phase 2 at the sponsor's discretion.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells. | 3 |
| Cohort A: DL 2 (1x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells. | 3 |
| Cohort A: DL 3 (3x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells. | 6 |
| Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells. | 6 |
| Cohort A: DL 4a (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. | 10 |
| Cohort A: DL 4b (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1. | 35 |
| Cohort B: DL 4 (6x10^8 CAR+ T Cells) Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. | 1 |
| Cohort C: DL 3 (3x10^8 CAR+ T Cells) Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells. | 5 |
| Cohort C: DL 4 (6x10^8 CAR+ T Cells) Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. | 5 |
| B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells. | 4 |
| B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells. | 5 |
| B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells. | 7 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase (Up to 5 Years) | Death | 3 | 1 | 4 | 3 | 8 | 3 | 0 | 1 | 3 | 4 | 3 | 2 | 1 |
| Dose Escalation Phase (Up to 5 Years) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dose Escalation Phase (Up to 5 Years) | Study terminated by the Sponsor | 0 | 1 | 2 | 0 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 2 | 6 |
| Dose Escalation Phase (Up to 5 Years) | Withdrawal by Subject | 0 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Dose Expansion Phase (Up to 5 Years) | Death | 0 | 0 | 0 | 0 | 0 | 14 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dose Expansion Phase (Up to 5 Years) | Study terminated by the Sponsor | 0 | 0 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dose Expansion Phase (Up to 5 Years) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 14.5 | 47.7 Years STANDARD_DEVIATION 17.61 | 39.4 Years STANDARD_DEVIATION 13.83 | 35.0 Years STANDARD_DEVIATION 10.3 | 63.8 Years STANDARD_DEVIATION 6.65 | 71.0 Years STANDARD_DEVIATION 8.43 | 59.0 Years | 64.0 Years STANDARD_DEVIATION 11.74 | 61.8 Years STANDARD_DEVIATION 10.9 | 61.5 Years STANDARD_DEVIATION 18.29 | 68.2 Years STANDARD_DEVIATION 5.34 | 65.3 Years STANDARD_DEVIATION 8.08 | 54.3 Years STANDARD_DEVIATION 5.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 75 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 1 Participants | 30 Participants | 7 Participants | 4 Participants | 6 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 29 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 9 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 61 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 26 Participants | 8 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 2 / 3 | 4 / 11 | 3 / 6 | 9 / 10 | 21 / 35 | 1 / 1 | 3 / 5 | 4 / 5 | 4 / 4 | 2 / 5 | 1 / 7 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 6 / 6 | 6 / 6 | 10 / 10 | 34 / 35 | 1 / 1 | 5 / 5 | 5 / 5 | 4 / 4 | 5 / 5 | 7 / 7 |
| serious Total, serious adverse events | 3 / 3 | 2 / 3 | 1 / 6 | 1 / 6 | 5 / 10 | 8 / 35 | 0 / 1 | 1 / 5 | 4 / 5 | 3 / 4 | 3 / 5 | 1 / 7 |
Outcome results
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment \[e.g., 1 mg/kg/day\], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Time frame: Up to 28 days
Population: DLT Evaluable Set comprised of participants who received CTX110 and are followed for at least 28 days post-infusion or withdraw consent after experiencing a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population | 0 Participants |
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Time frame: Up to 5 years
Population: Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population | 60.9 Percentage of participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population | 75.0 Percentage of participants |
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level.
Time frame: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24
Population: Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 6 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | 3.88 Copies per micrograms DNA | Standard Deviation 1.379 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 8.36 Copies per micrograms DNA | Standard Deviation 5.31 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 3763.68 Copies per micrograms DNA | Standard Deviation 8138.642 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 7.27 Copies per micrograms DNA | Standard Deviation 6.403 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 4.00 Copies per micrograms DNA | Standard Deviation 2.452 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 180.87 Copies per micrograms DNA | Standard Deviation 209.131 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 25.47 Copies per micrograms DNA | Standard Deviation 21.898 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 144.95 Copies per micrograms DNA | Standard Deviation 147.856 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | 3.55 Copies per micrograms DNA | Standard Deviation 1.126 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 220.78 Copies per micrograms DNA | Standard Deviation 246.411 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 12 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 3.55 Copies per micrograms DNA | Standard Deviation 1.592 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 4337.42 Copies per micrograms DNA | Standard Deviation 7721.088 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 9 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 452.03 Copies per micrograms DNA | Standard Deviation 941.853 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 829.37 Copies per micrograms DNA | Standard Deviation 1552.483 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 3.55 Copies per micrograms DNA | Standard Deviation 1.592 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 6 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 10.77 Copies per micrograms DNA | Standard Deviation 13.999 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 24 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 12.46 Copies per micrograms DNA | Standard Deviation 9.656 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 22.03 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 472.20 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 28.57 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 311.67 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 13269.43 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 25719.13 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 9.93 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 6 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 9 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 12 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 24 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 105.22 Copies per micrograms DNA | Standard Deviation 23.028 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 64.48 Copies per micrograms DNA | Standard Deviation 123.167 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 12 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | 11.17 Copies per micrograms DNA | Standard Deviation 14.318 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 80.40 Copies per micrograms DNA | Standard Deviation 33.878 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 35.62 Copies per micrograms DNA | Standard Deviation 22.359 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 5844.98 Copies per micrograms DNA | Standard Deviation 9600.631 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 19018.53 Copies per micrograms DNA | Standard Deviation 42303.294 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 16.76 Copies per micrograms DNA | Standard Deviation 13.05 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 24 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 6.67 Copies per micrograms DNA | Standard Deviation 8.437 |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 2435.23 Copies per micrograms DNA | Standard Deviation 5423.525 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 24 | NA Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 51.73 Copies per micrograms DNA | Standard Deviation 87.882 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 3.88 Copies per micrograms DNA | Standard Deviation 1.95 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 204.43 Copies per micrograms DNA | Standard Deviation 300.219 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 72.39 Copies per micrograms DNA | Standard Deviation 107.323 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 12 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 636.29 Copies per micrograms DNA | Standard Deviation 352.7 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 719.13 Copies per micrograms DNA | Standard Deviation 231.318 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 297.91 Copies per micrograms DNA | Standard Deviation 248.623 |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 487.13 Copies per micrograms DNA | Standard Deviation 262.303 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 2 | 42.39 Copies per micrograms DNA | Standard Deviation 101.461 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 28 | 8.32 Copies per micrograms DNA | Standard Deviation 28.058 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 8 | 10277.87 Copies per micrograms DNA | Standard Deviation 27526.126 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 5 | 770.14 Copies per micrograms DNA | Standard Deviation 3312.713 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 21 | 2537.64 Copies per micrograms DNA | Standard Deviation 11074.754 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 pre-infusion | 3.08 Copies per micrograms DNA | Standard Deviation 0.934 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 1 post-infusion | 979.25 Copies per micrograms DNA | Standard Deviation 1658.499 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 3 | 35.80 Copies per micrograms DNA | Standard Deviation 98.739 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 2 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 14 | 2186.81 Copies per micrograms DNA | Standard Deviation 13766.282 |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Month 3 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population | Day 10 | 4056.03 Copies per micrograms DNA | Standard Deviation 19737.607 |
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities.
Time frame: Up to 5 years
Population: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 1 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 3 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 1 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 1 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 3 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 3 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 1 Participants |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 3 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 2 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 2 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 3 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 1 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 4 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 3 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 4 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 1 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 3 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 6 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 10 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 8 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 10 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 10 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 35 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 35 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 35 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 17 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 19 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 3 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 2 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 4 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 1 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 1 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 1 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 1 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 1 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 2 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 2 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 1 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 2 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 1 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 1 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 2 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 3 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 1 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 5 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 1 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 2 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 2 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 4 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 4 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 4 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoalbuminemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Platelet count decreased | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Blood bilirubin increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hyperkalemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count decreased | 7 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypermagnesemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypernatremia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Activated partial thromboplastin time prolonged | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Lymphocyte count increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Chronic kidney disease | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Anemia | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Neutrophil count decreased | 7 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Creatinine increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Aspartate aminotransferase increased | 1 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Leukocytosis | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Alanine aminotransferase increased | 2 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypoglycemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | White blood cell decreased | 7 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | INR increased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Fibrinogen decreased | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypercalcemia | 0 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population | Hypokalemia | 0 Participants |
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Time frame: Up to 5 years
Population: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 3 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 2 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 1 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 1 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 5 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 8 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 0 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 1 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 4 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 3 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population | 1 Participants |
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Time frame: Up to 5 years
Population: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 3 Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 3 Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 6 Participants |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 6 Participants |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 10 Participants |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 34 Participants |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 1 Participants |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 5 Participants |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 4 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 5 Participants |
| Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population | 7 Participants |
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation.
Time frame: Up to 5 years
Population: Full Analysis Set: Participants who reported objective response events were analyzed. The duration of response for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 9.20 Months |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 3.75 Months |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 3.52 Months |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 1.02 Months |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 3.60 Months |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | NA Months |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 2.20 Months |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population | 1.56 Months |
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion.
Time frame: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 14 | 1040.13 Copies per micrograms DNA | Standard Deviation 1466.869 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 5 | 28.65 Copies per micrograms DNA | Standard Deviation 36.011 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 28 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 10 | 226.32 Copies per micrograms DNA | Standard Deviation 290.508 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 8 | 71.30 Copies per micrograms DNA | Standard Deviation 118.215 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 pre-infusion | 13.43 Copies per micrograms DNA | Standard Deviation 21.067 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 2 | 4.20 Copies per micrograms DNA | Standard Deviation 2.252 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 post-infusion | 781.86 Copies per micrograms DNA | Standard Deviation 1395.907 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 21 | 3.55 Copies per micrograms DNA | Standard Deviation 1.126 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 3 | 13.46 Copies per micrograms DNA | Standard Deviation 14.905 |
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Month 2 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 8 | 16846.17 Copies per micrograms DNA | Standard Deviation 33459.507 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 pre-infusion | 3.29 Copies per micrograms DNA | Standard Deviation 0.872 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 post-infusion | 1983.57 Copies per micrograms DNA | Standard Deviation 1677.746 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 2 | 93.47 Copies per micrograms DNA | Standard Deviation 149.22 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 3 | 20.47 Copies per micrograms DNA | Standard Deviation 25.356 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 5 | 42.37 Copies per micrograms DNA | Standard Deviation 47.444 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 10 | 26.17 Copies per micrograms DNA | Standard Deviation 41.517 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 14 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 21 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 28 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Month 2 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 28 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 14 | 380.29 Copies per micrograms DNA | Standard Deviation 924.424 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 2 | 18.13 Copies per micrograms DNA | Standard Deviation 17.532 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 pre-infusion | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 21 | 2.90 Copies per micrograms DNA | Standard Deviation 0 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 1 post-infusion | 602.75 Copies per micrograms DNA | Standard Deviation 521.357 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 8 | 15941.89 Copies per micrograms DNA | Standard Deviation 30200.959 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 5 | 62.85 Copies per micrograms DNA | Standard Deviation 124.743 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Month 2 | 2.90 Copies per micrograms DNA | — |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 10 | 14177.59 Copies per micrograms DNA | Standard Deviation 23256.089 |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population | Day 3 | 7.95 Copies per micrograms DNA | Standard Deviation 4.705 |
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation.
Time frame: Up to 5 years
Population: Full Analysis Set: Participants reporting overall survival rate were analyzed. The median overall survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 5.03 Months |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 37.16 Months |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 7.77 Months |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | NA Months |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 5.16 Months |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 14.26 Months |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 12.12 Months |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 7.39 Months |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population | 7.62 Months |
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation.
Time frame: Up to 5 years
Population: Full Analysis Set: Participants who reported PFS events were analyzed. The progression free survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 0.92 Months |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 1.91 Months |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 2.43 Months |
| Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 1.54 Months |
| Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 1.77 Months |
| Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 2.83 Months |
| Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | NA Months |
| Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 2.92 Months |
| Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells) | Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population | 1.94 Months |
Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Time frame: Up to 5 years
Population: Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells) | Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population | 25.0 Percentage of Participants |
| Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population | 40.0 Percentage of Participants |
| Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells) | Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population | 85.7 Percentage of Participants |