Refractory Diffuse Large B Cell Lymphoma
Conditions
Brief summary
The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).
Interventions
BIOLOGICALKTE-C19
A single infusion of KTE-C19 CAR-T cells administered intravenously
BIOLOGICALAtezolizumab
Administered intravenously
DRUGCyclophosphamide
Administered intravenously
DRUGFludarabine
Administered intravenously
Sponsors
Genentech, Inc.
Kite, A Gilead Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a single group design. The arms reported in the Arms and Intervention section are based on the atezolizumab dosing schedule in the 4 Cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Histologically confirmed DLBCL 2. Chemotherapy-refractory disease, defined as one or more of the following: * Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy containing regimen * Disease progression or recurrence less than or equal to 12 months of prior autologous stem cell transplantation (SCT) 3. Individuals must have received adequate prior therapy including at a minimum: * Anti-cluster of differentiate 20 (anti-CD20) monoclonal antibody unless investigator determines that tumor is CD20-negative; and * an anthracycline containing chemotherapy regimen 4. At least one measurable lesion per revised International Working Group (IWG) Response Criteria 5. Age 18 years or older 6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 7. Adequate organ and bone marrow function 8. All individuals or legally appointed representatives/caregivers, must personally sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved consent form before initiating any study specific procedures or activities. Key
Exclusion criteria
1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years 2. History of allogeneic stem cell transplantation 3. Prior CAR therapy or other genetically modified T cell therapy 4. Clinically significant active infection 5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) 6. Individuals with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases 7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 8. History of autoimmune disease. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and participants with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study. 9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 10. Prior treatment with Programmed Cell Death Ligand 1 (PD-L1) inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137, anti-OX40 or other immune checkpoint blockade or activator therapy with the exception of Individuals who received atezolizumab in this study and are eligible for re-treatment 11. Prior CD19 targeted therapy Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Baseline up to 21 days | A DLT was defined as the following KTE-C19-related or ATZ-related events with an onset from immediately after the first ATZ infusion through 21 days after the first ATZ infusion: Grade 4 hematologic toxicity lasting \> 30 days (except lymphopenia or B-cell aplasia); All KTE-C19- or ATZ-related Grade 3 non-hematologic toxicities lasting for \> 7 days and all KTE-C19- or ATZ-related Grade 4 non-hematologic toxicities regardless of duration. |
| Phase 1 and 2: Complete Response Rate (CRR) | From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years) | CRR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 and 2: Progression-Free Survival (PFS) | From the date of first KTE-C19 infusion to disease progression or death regardless of cause (maximum duration: 6.2 years) | PFS was defined as the time from the KTE-C19 infusion date to the date of disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death from any cause. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate PFS. |
| Phase 1 and 2: Overall Survival (OS) | From the date of first KTE-C19 infusion to the date of death regardless of cause (maximum duration: 6.2 years) | OS was defined as the time from KTE-C19 infusion to the date of death from any cause. The Kaplan-Meier approach was used to estimate OS. |
| Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 1.8 years | An adverse event was defined as any untoward medical occurrence in a clinical trial participant. The event did not necessarily have a relationship with study treatment. Adverse events included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while in study, was not considered an adverse event. TEAEs included all AEs with onset on or after initiation of axicabtagene ciloleucel. |
| Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Up to 1.8 years | Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase. |
| Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Up to 1.8 years | Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. |
| Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Up to 1.8 years | Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. |
| Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Up to 1.8 years | Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. |
| Phase 1 and 2: Objective Response Rate (ORR) | From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years) | ORR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a CR or partial response (PR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Participants who did not meet the criteria for objective response by the analysis cutoff date were considered non-responders. |
| Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Atezolizumab Levels in Blood | Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174 | — |
| Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Peak Serum Levels of Ferritin in Blood | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood | Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion | — |
| Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood | Pre-infusion (Baseline); Post-infusion: Days 7 (Phase 2), 14, 22 (Phase 2), 28 (Phase 2; optional), 35 (Phase 1, Cohort 3; optional), 43, 49 (optional), 64, 69 (optional), 94; long-term follow-up: every 3 months from Month 6 to Month 18, and Month 24 | — |
| Phase 1 and 2: Duration of Response (DOR) | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (maximum duration: 6.2 years) | DOR for participants who experienced an objective response was defined as the date of their first confirmed objective response (CR or PR) to disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death regardless of cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate DOR. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States.
Pre-assignment details
44 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19. | 3 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19. | 3 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19. | 6 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19. | 22 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Death | 1 | 1 | 2 | 13 |
| Overall Study | Full Consent Withdrawal | 0 | 0 | 0 | 2 |
| Overall Study | Investigator Decision | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 3 |
| Overall Study | Partial Withdrawal of Consent | 0 | 0 | 0 | 1 |
| Overall Study | Rolled Over to Long-term Follow-up Study | 0 | 0 | 3 | 4 |
Baseline characteristics
| Characteristic | Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Total | Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 4 Participants | 6 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 6 Participants | 18 Participants | 28 Participants | 2 Participants |
| Age, Continuous | 42.7 years STANDARD_DEVIATION 19.5 | 53.2 years STANDARD_DEVIATION 6.18 | 58.4 years STANDARD_DEVIATION 7.4 | 56 years STANDARD_DEVIATION 9.9 | 56.0 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 6 Participants | 20 Participants | 30 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 3 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 5 Participants | 18 Participants | 28 Participants | 2 Participants |
| Region of Enrollment United States | 3 Participants | 6 Participants | 22 Participants | 34 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 8 Participants | 14 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 14 Participants | 20 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 1 / 4 | 2 / 7 | 14 / 23 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 6 / 6 | 22 / 22 |
| serious Total, serious adverse events | 3 / 3 | 2 / 3 | 3 / 6 | 15 / 22 |
Outcome results
Primary
Phase 1 and 2: Complete Response Rate (CRR)
CRR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
Time frame: From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years)
Population: The Modified Intent-to-Treat Analysis (mITT) Set included all participants enrolled in Phase 1 Cohort 3 and Phase 2 and treated with target dose of KTE-C19 and at least one dose of atezolizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Complete Response Rate (CRR) | 54 percentage of participants |
Primary
Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
A DLT was defined as the following KTE-C19-related or ATZ-related events with an onset from immediately after the first ATZ infusion through 21 days after the first ATZ infusion: Grade 4 hematologic toxicity lasting \> 30 days (except lymphopenia or B-cell aplasia); All KTE-C19- or ATZ-related Grade 3 non-hematologic toxicities lasting for \> 7 days and all KTE-C19- or ATZ-related Grade 4 non-hematologic toxicities regardless of duration.
Time frame: Baseline up to 21 days
Population: DLT Evaluable Set included all participants in Phase 1 treated with KTE-C19 and at least 1 dose of ATZ who either received target KTE-C19 dose and followed for at least 21 days after first ATZ infusion; or received a dose of KTE-C19 lower than target for that cohort and a subsequent ATZ infusion and experienced a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | 1 Participants |
Secondary
Phase 1 and 2: Atezolizumab Levels in Blood
Time frame: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 84 | 209000 ng/mL | Standard Deviation 24800 |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 63 | 175000 ng/mL | Standard Deviation 7505.55 |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 42 | 98800 ng/mL | Standard Deviation 16500 |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 21 | 403000 ng/mL | Standard Deviation 46100 |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 174 | 91000 ng/mL | — |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 14 | 435000 ng/mL | Standard Deviation 61500 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 56 | 176000 ng/mL | Standard Deviation 2828.43 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 35 | 84200 ng/mL | Standard Deviation 14300 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 77 | 240000 ng/mL | Standard Deviation 33000 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 1 | 373000 ng/mL | Standard Deviation 65300 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 22 | 73900 ng/mL | Standard Deviation 27900 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 43 | 138000 ng/mL | Standard Deviation 78700 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 64 | 159000 ng/mL | Standard Deviation 91600 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 154 | 13600 ng/mL | — |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 43 | 136000 ng/mL | Standard Deviation 69900 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 22 | 110000 ng/mL | Standard Deviation 126000 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 1 | 328000 ng/mL | Standard Deviation 89100 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 154 | 66800 ng/mL | Standard Deviation 58900 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Atezolizumab Levels in Blood | Day 64 | 185000 ng/mL | Standard Deviation 88700 |
Secondary
Phase 1 and 2: Duration of Response (DOR)
DOR for participants who experienced an objective response was defined as the date of their first confirmed objective response (CR or PR) to disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death regardless of cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate DOR.
Time frame: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (maximum duration: 6.2 years)
Population: Participants in the mITT Analysis Set with objective response were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Duration of Response (DOR) | 41.4 months |
Secondary
Phase 1 and 2: Objective Response Rate (ORR)
ORR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a CR or partial response (PR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Participants who did not meet the criteria for objective response by the analysis cutoff date were considered non-responders.
Time frame: From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years)
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Objective Response Rate (ORR) | 75 percentage of participants |
Secondary
Phase 1 and 2: Overall Survival (OS)
OS was defined as the time from KTE-C19 infusion to the date of death from any cause. The Kaplan-Meier approach was used to estimate OS.
Time frame: From the date of first KTE-C19 infusion to the date of death regardless of cause (maximum duration: 6.2 years)
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Overall Survival (OS) | 32.2 months |
Secondary
Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood
Time frame: Pre-infusion (Baseline); Post-infusion: Days 7 (Phase 2), 14, 22 (Phase 2), 28 (Phase 2; optional), 35 (Phase 1, Cohort 3; optional), 43, 49 (optional), 64, 69 (optional), 94; long-term follow-up: every 3 months from Month 6 to Month 18, and Month 24
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood | 86.87 cells/μL | Standard Deviation 67.17 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood | 167.88 cells/μL | Standard Deviation 91.58 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood | 60.71 cells/μL | Standard Deviation 70.66 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood | 60.22 cells/μL | Standard Deviation 60.24 |
Secondary
Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood | 174.03 mg/L |
Secondary
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | CXCL 10 | 2000.00 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IFN-γ | 587.80 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IL-1RA | 2469.60 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IL-2 | 17.55 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IL-6 | 121.55 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IL-8 | 180.65 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | IL-15 | 48.95 pg/mL |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood | TNF-α | 8.20 pg/mL |
Secondary
Phase 1 and 2: Peak Serum Levels of Ferritin in Blood
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of Ferritin in Blood | 1427.39 ng/mL |
Secondary
Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood | 17.75 ng/mL |
Secondary
Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. The event did not necessarily have a relationship with study treatment. Adverse events included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while in study, was not considered an adverse event. TEAEs included all AEs with onset on or after initiation of axicabtagene ciloleucel.
Time frame: Up to 1.8 years
Population: The Safety Analysis Set was defined as all participants treated with any dose of KTE-C19.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies | 0 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies
Time frame: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies | 0 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.
Time frame: Up to 1.8 years
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 hemoglobin | 100 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 leukocytes | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 leukocytes | 100 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 lymphocytes | 100 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 neutrophils | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 neutrophils | 100 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 platelets | 33 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 platelets | 33 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 neutrophils | 67 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 neutrophils | 33 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 leukocytes | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 platelets | 67 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 platelets | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 lymphocytes | 100 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 leukocytes | 100 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 hemoglobin | 67 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 platelets | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 leukocytes | 67 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 lymphocytes | 100 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 neutrophils | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 neutrophils | 83 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 platelets | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 hemoglobin | 83 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 leukocytes | 33 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 leukocytes | 77 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 lymphocytes | 86 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 leukocytes | 18 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 hemoglobin | 59 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 neutrophils | 14 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 platelets | 32 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 platelets | 18 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 neutrophils | 73 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.
Time frame: Up to 1.8 years
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | 0 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.
Time frame: Up to 1.8 years
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 albumin | 33 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 calcium | 33 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 phosphate | 67 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 phosphate | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 potassium | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 sodium | 67 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 potassium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 phosphate | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 calcium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 sodium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 phosphate | 67 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 albumin | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 sodium | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 phosphate | 33 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 phosphate | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 potassium | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 glucose | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 albumin | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 calcium | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 calcium | 18 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 phosphate | 36 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 calcium | 5 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 albumin | 9 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 phosphate | 36 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 sodium | 14 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values | Shift to Grade 3 potassium | 14 percentage of participants |
Secondary
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase.
Time frame: Up to 1.8 years
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 direct bilirubin | 33 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 creatinine | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALT | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 creatinine | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALP | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 AST | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 ALT | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 glucose | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 AST | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 bilirubin | 0 percentage of participants |
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 ALT | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 AST | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 creatinine | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 direct bilirubin | 33 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 creatinine | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALT | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 bilirubin | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 AST | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALP | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 glucose | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 creatinine | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALT | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 ALT | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALP | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 AST | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 AST | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 bilirubin | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 calcium | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 creatinine | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 direct bilirubin | 17 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 glucose | 0 percentage of participants |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 glucose | 0 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 bilirubin | 9 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 AST | 5 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALT | 5 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 direct bilirubin | 14 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 AST | 9 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 ALP | 14 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 glucose | 14 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 glucose | 18 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 3 creatinine | 9 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 calcium | 5 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 ALT | 5 percentage of participants |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values | Shift to Grade 4 creatinine | 5 percentage of participants |
Secondary
Phase 1 and 2: Progression-Free Survival (PFS)
PFS was defined as the time from the KTE-C19 infusion date to the date of disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death from any cause. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate PFS.
Time frame: From the date of first KTE-C19 infusion to disease progression or death regardless of cause (maximum duration: 6.2 years)
Population: Participants in the mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | Phase 1 and 2: Progression-Free Survival (PFS) | 9 months |