Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, B Cell, B-Cell Lymphoma, B-Cell Leukemia, Acute Lymphoid Leukemia, B-Non Hodgkin Lymphoma, B-NHL, B-All, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia
Conditions
Keywords
B-Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, B-precursor ALL, B-All, Philadelphia chromosome + ALL, Lymphoma, CD-22 Expressing Tumor, CD-19 expressing tumor, Adoptive Immunotherapy
Brief summary
Background: B-cell leukemias and lymphomas are cancers that are often difficult to treat. The primary objective of this study is to determine the ability to take a patient's own cells (T lymphocytes) and grow them in the laboratory with the cluster of differentiation 19 (CD19/cluster of differentiation 22-chimeric antigen receptor (CD22-CAR) gene through a process called 'lentiviral transduction (also considered gene therapy) and growing them to large numbers to use as a treatment for hematologic cancers in children and young adults.. Researchers want to see if giving modified CD19/CD22-CAR T cells to people with these cancers can attack cancer cells. In addition, the safety of giving these gene modified cells to humans will be tested at different cell doses. Additional objectives are to determine if this therapy can cause regression of B cell cancers and to measure if the gene modified cells survive in patients' blood. Objective: To study the safety and effects of giving CD19/CD22-CAR T cells to children and young adults with B-cell cancer. Eligibility: People ages 3-39 with certain cancers that have not been cured by standard therapy. Their cancer tissue must express the CD19 protein. Design: A sample of participants blood or bone marrow will be sent to National Institutes of Health (NIH) and tested for leukemia. Participants will be screened with: Medical history Physical exam Urine and blood tests (including for human immunodeficiency virus (HIV) Heart and eye tests Neurologic assessment and symptom checklist. Scans, bone marrow biopsy, and/or spinal tap Some participants will have lung tests. Participants will repeat these tests throughout the study and follow-up. Participants will have leukapheresis. Blood will be drawn from a plastic tube (intravenous (IV) or needle in one arm then go through a machine that removes lymphocytes. The remaining blood will be returned to the participant's other arm. Participants will stay in the hospital about 2 weeks. There they will get: Two chemotherapy drugs by IV Their changed cells by IV Standard drugs for side effects Participants will have frequent follow-up visits for 1 year, then 5 visits for the next 4 years. Then they will answer questions and have blood tests every year for 15 years. ...
Detailed description
Background: * Acute lymphoblastic leukemia (ALL) accounts for approximately 25% of childhood cancer. Survival rates have improved, but outcomes for some subgroups, including infants and young adults remain poor, and survival for patients who relapse is \< 50%, despite allogeneic stem cell transplant following second remission. * Cluster of differentiation 19 (CD19 immune escape has been observed by several groups following CD19-chimeric antigen receptor (CAR) therapy for B-ALL. Investigation of this phenomenon reveals a complex biology responsible for loss or downregulation of CD19 expression observed in these cases. * Sequential therapy using cluster of differentiation 22 (CD22)-CARs to treat CD19 dim/lo escape is associated with rapid development of resistance due to CD22 downregulation. This trial will test whether simultaneous targeting of CD19 and CD22 using a novel bivalent CD19/22-CAR is safe and feasible. Objectives: -Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells that meet established release specifications in children and young adults with CD19+CD22+ B cell ALL, isolated central nervous system (CNS) ALL, or lymphoma following a cyclophosphamide/fludarabine conditioning regimen. Eligibility: -Participants between \>= 3 years and \<= 39 years of age, with CD19+/CD22+ B cell ALL, isolated CNS ALL, or lymphoma who have relapsed or have refractory disease after at least one standard chemotherapy regimen and one salvage regimen, with no alternative curative options who meet standard Phase I eligibility criteria. Design: * Phase I, 3 + 3 dose escalation design using the following dose levels: -1: 1 x 10\^5 transduced T cells/kg (+/- 20%); 1: 3 x 10\^5 transduced T cells/kg (+/- 20%); 2: 1 x 10\^6 transduced T cells/kg; and 3: 3 x 10\^6 transduced T cells/kg (+/- 20%); 4: 1 x 10\^7 transduced T cells/kg (+/- 20%). * Participants will receive a lymphodepleting preparative regimen of fludarabine (25 mg/m\^2/day (d) x 3 on Days -4, -3, -2) and cyclophosphamide (900 mg/m\^2/d x 1 on Day -2) followed by infusion of CD19/CD22-CAR T-cells on D0. Participants who are CAR pretreated (with exception for those with an interval hematopoietic stem cell transplantation (HSCT) will receive increased lymphodepleting preparative regimen of fludarabine (30\^mg/m\^2/d x 4 on Days -5, -4, -3, -2) and cyclophosphamide (600 mg/m\^2/d x 2 on Days -3, -2) followed by infusion of CD19/CD22-CAR T-cells on D0. If fludarabine is unavailable, pentostatin may be given as an alternative. * Patients will be evaluated sequentially for toxicity, antitumor effects, CAR expansion and persistence, as well as research correlatives.
Interventions
BIOLOGICALCD19/CD22 CAR T-Cells
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) chimeric antigen receptor (CAR) T-cells will be infused on Day 0 after lymphodepleting chemotherapy regimen.
DRUGFludarabine
Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on body surface area (BSA) (25-30 mg/m\^2/dose) on Days -4, -3, -2 or Days -5, -4, -3, -2.
DRUGCyclophosphamide
Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA), at 900 mg/m\^2/dose after fludarabine infusion on Day -2 or 600 mg/m\^2/dose on Days -3 & -2.
PROCEDUREApheresis
According to institutional standards.
OTHERAnti-emetic
Prophylaxis and treatment.
DRUGDiphenhydramine
Pre-medication: 0.5-1 mg/kg/dose (maximum 50 mg/dose) by mouth or intravenous over 10-15 minutes.
DRUGAcetaminophen
Pre-medication: 15 mg/kg/dose (maximum 650 mg/dose by mouth).
DIAGNOSTIC_TESTECG
Pre-cell infusion.
DIAGNOSTIC_TESTECHO
Pre-cell infusion.
DIAGNOSTIC_TESTMRI Brain
Pre-cell infusion.
PROCEDUREBone marrow biopsy
Pre-cell infusion.
DIAGNOSTIC_TESTCardiac MRI
Screening
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* ELIGIBILITY CRITERIA: Study subjects with cluster of differentiation 19 (CD19) + cluster of differentiation 22 (CD22+) expressing B cell malignancies who have relapsed or are treatment refractory may enroll as defined by the following inclusion and
Exclusion criteria
. INCLUSION CRITERIA: * Diagnosis * Participant must have a B cell acute lymphoblastic leukemia (ALL) (inclusive of chronic myeloid leukemia (CML) with ALL transformation) or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy regimen and one salvage regimen. In view of the principal investigator (PI) and the primary oncologist, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment. Participants who have undergone autologous SCT will be eligible, and participants that have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they have no evidence of graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor. * Participants must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis. For those being considered for reinfusions, measurable or evaluable disease is not required at the time of reinfusion. * CD22/CD19 expression --CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each participant. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples. CD22+ B cell malignancy is required and CD22 expression levels will be documented when available, but a specific level of expression is not an eligibility requirement; it may be documented as positive or negative. * Age: --Greater than or equal to 3 years of age (and at least 15 kg) and less than or equal to 39 years of age at time of enrollment (greater than or equal to 3 years to less than or equal to 39 years). NOTE: The first participant in each dose cohort must be greater than or equal to 18 years of age. * Clinical Performance --Clinical performance status: Participants greater than or equal to 16 years of age: Karnofsky greater than or equal to 50%; Participants \< 16 years of age: Lansky scale greater than or equal to 50%. Subjects who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score. * Participants must have adequate organ and marrow function as defined below: * leukocytes greater than or equal to 750/mcL\* * platelets greater than or equal to 50,000/mcL\* * total bilirubin less than or equal to 2 X upper limit of normal (ULN) (except in the case of subjects with documented Gilbert's disease \> 3x ULN) * Aspartate aminotransferase (AST)serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT)serum glutamate pyruvate transaminase (SGPT) less than or equal to 10 X institutional upper limit of normal * creatinine less than or equal to the maximum for age listed in the table below * Age (Years): less than or equal to 5. Maximum Serum Creatinine (mg/dL): less than or equal to 0.8 * Age (Years): 6 to less than or equal to 10. Maximum Serum Creatinine (mg/dL): less than or equal to 1.0 * Age (Years): \>10. Maximum Serum Creatinine (mg/dL): less than or equal to 1.2 * OR * creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal. * if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia greater than or equal to Grade 3 if it is due to disease, based on the results of bone marrow studies. * Subjects with central nervous system (CNS) disease are eligible, with exceptions as noted in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grades of Toxicity by Type of Toxicity | From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks). | Safety analyses will consist of tabulations of grades of toxicity by type of toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Maximum Tolerated Dose (MTD) | First 28 days after cell infusion | MTD is defined as the dose level immediately below the level at which the enrollment is stopped due to dose-limiting toxicity (DLT). A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Number of months from CAR cell infusion until date of death or time of censor (max 66.6 months) | Overall survival (OS) will be determined as the time from the date of chimeric antigen receptor (CAR) infusion until death. |
| Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | At Day 28 (+/- 4 days) after CAR cell infusion | Clinical activity (response) in children (age ≥3 years to 17 years) and young adults (age 18 years to ≤ 39 years) was measured by the Response Criteria Lymphoma. Complete Response (CR) is complete metabolic and/or radiographic response. Partial Response (PR) is partial metabolic response or partial remission. Stable Disease (SD) is no metabolic response or 50% decrease from baseline in the sum of products of diameters (SPD) of up to 6 dominant measurable nodes and extra nodal sites. Progressive Disease (PD) is individual node/lesion must be abnormal with longest transverse diameter of a lesion (LDI) \>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in LDI or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm and/or 1.0 cm for lesions \> 2 cm; also assessed by the International Working Group and PD is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts. |
| Progression-free Survival (PFS) | Number of months from CAR cell infusion until time of disease progression, death, or date of censor (up to 67 months) | PFS is assessed from the date of chimeric antigen receptor (CAR) infusion until the documentation of disease progression or death due to any cause, whichever occurs first. Disease progression was assessed by the Response Criteria Lymphoma and is defined as individual node/lesion must be abnormal with LDI\>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in longest transverse diameter of a lesion (LDI) or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions \> 2 cm; and the International Working Group and is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts. |
| Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | CAR infusion (Day 0) | Number of participants that have the targeted dose number of CAR cells successfully manufactured (i.e., number of participants enrolled where the correct number of cells are produces at the dose level that are enrolled) as measured by total number of viable cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) transduced T cells. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Dose-limiting Toxicity (DLT) | First 28 days | A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion. |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Adverse Events were monitored/assessed from the first study intervention, Study Day -4, through day 30 after the study agent (s) was/were administered, an average of 5 weeks. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells Dose Level 1, 3 x10\^5 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 4 |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 2, 1x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 4 |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 5 |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) Participants who are chimeric antigen receptor (CAR) naïve or CAR pre-treated and received an interval transplant.
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 2 |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) Participants who previously received Chimeric Antigen Receptor (CAR) therapy.
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 30 mg/m\^2/dose on Day -5, -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 600 mg/m\^2/dose after fludarabine infusion on Day -3 & -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 1 |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) Participants who are chimeric antigen receptor (CAR) naïve or CAR pre-treated and received an interval transplant.
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 21 |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% Participants who previously received Chimeric Antigen Receptor (CAR) therapy.
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 30 mg/m\^2/dose on Day -5, -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 600 mg/m\^2/dose after fludarabine infusion on Day -3 & -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 1 |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) Participants with isolated central nervous system (CNS) disease.
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 1 |
| Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated Participants were enrolled for screening but were not enrolled on treatment. | 15 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation | Not Treated - participant did not receive cell infusion. | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 |
| Dose Expansion | Not treated - screen failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
Baseline characteristics
| Characteristic | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 8 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 13 Participants | 0 Participants | 1 Participants | 3 Participants | 10 Participants | 36 Participants |
| Age, Continuous | 24.75 years STANDARD_DEVIATION 3.97 | 19.12 years STANDARD_DEVIATION 8.73 | 25.75 years STANDARD_DEVIATION 3.45 | 9.7 years STANDARD_DEVIATION 0 | 21 years STANDARD_DEVIATION 10.86 | 18.2 years STANDARD_DEVIATION 0 | 22.6 years STANDARD_DEVIATION 0 | 15.88 years STANDARD_DEVIATION 6.06 | 21.75 years STANDARD_DEVIATION 10.91 | 20.69 years STANDARD_DEVIATION 10.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 12 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 9 Participants | 1 Participants | 0 Participants | 3 Participants | 7 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 11 Participants | 1 Participants | 1 Participants | 2 Participants | 9 Participants | 31 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 2 participants | 1 participants | 21 participants | 1 participants | 1 participants | 4 participants | 15 participants | 54 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 9 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 12 Participants | 0 Participants | 1 Participants | 3 Participants | 9 Participants | 33 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 4 | 3 / 4 | 2 / 4 | 2 / 2 | 0 / 1 | 8 / 21 | 1 / 1 | 0 / 1 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 4 / 4 | 2 / 2 | 1 / 1 | 21 / 21 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 2 / 4 | 2 / 4 | 0 / 4 | 2 / 2 | 1 / 1 | 7 / 21 | 0 / 1 | 1 / 1 |
Outcome results
Primary
Grades of Toxicity by Type of Toxicity
Safety analyses will consist of tabulations of grades of toxicity by type of toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Time frame: From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks).
Population: 16/54 participants were not treated including 15 participants that were screen failures. Only grade 3, 4, and 5 toxicities at least possibly related to either research and/or investigational new drug application (IND) will be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 4 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 3 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 2 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 1 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 3 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 2 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 3 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 2 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 3 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 2 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 1 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 3 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 2 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 3 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 1 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 4 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 2 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 1 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 3 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 1 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 4 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 3 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 2 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 0 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 1 toxicities |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 1 toxicities |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 13 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 13 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 4 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 10 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 2 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 2 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 2 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 3 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 6 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 17 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 3 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 14 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 8 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 6 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 16 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 17 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 1 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 13 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 1 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Headache | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Neutrophil count decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Anemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (ICANS) | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Cytokine release syndrome | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypokalemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Back pain | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Platelet count decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Abdominal pain | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Fever | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 White blood cell decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypocalcemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Seizure | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Neutrophil count decreased | 1 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Gastric hemorrhage | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypoxia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anorexia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Diarrhea | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Lymphocyte count decreased | 1 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypotension | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 White blood cell decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 GGT increased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Myalgia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Hypertriglyceridemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Anemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sinus tachycardia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Aspartate aminotransferase | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Febrile neutropenia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Alanine aminotransferase | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Lymphocyte count decreased | 1 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Platelet count decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Dysphasia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Sepsis | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypokalemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertriglyceridemia | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Encephalopathy | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 4 Fibrinogen decreased | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Immune system disorders, other (GVHD) | 0 toxicities |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grades of Toxicity by Type of Toxicity | Grade 3 Hypertension | 0 toxicities |
Primary
Maximum Tolerated Dose (MTD)
MTD is defined as the dose level immediately below the level at which the enrollment is stopped due to dose-limiting toxicity (DLT). A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion.
Time frame: First 28 days after cell infusion
Population: 16/54 participants were not treated. Only participants in the dose escalation phase of the study are included in this analysis (Groups 1-5).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Maximum Tolerated Dose (MTD) | 3 10^6 CAR T cells/kg |
Secondary
Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive
Clinical activity (response) in children (age ≥3 years to 17 years) and young adults (age 18 years to ≤ 39 years) was measured by the Response Criteria Lymphoma. Complete Response (CR) is complete metabolic and/or radiographic response. Partial Response (PR) is partial metabolic response or partial remission. Stable Disease (SD) is no metabolic response or 50% decrease from baseline in the sum of products of diameters (SPD) of up to 6 dominant measurable nodes and extra nodal sites. Progressive Disease (PD) is individual node/lesion must be abnormal with longest transverse diameter of a lesion (LDI) \>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in LDI or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm and/or 1.0 cm for lesions \> 2 cm; also assessed by the International Working Group and PD is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts.
Time frame: At Day 28 (+/- 4 days) after CAR cell infusion
Population: 16/54 participants were not treated. Participants treated in Group 1-3 will be excluded from this outcome measure as assignment to CAR naïve versus CAR pre-treated did not occur in the beginning of the trial. The study was not looking at response in children vs young adults separately. It was looking at response in children and young adults only (no adults over 39). Also, it is not powered to look at children and young adults separately.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | CR in children and young adults | 50 percentage of participants |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PR in children and young adults | 50 percentage of participants |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PD in children and young adults | 0 percentage of participants |
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | SD in children and young adults | 0 percentage of participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | SD in children and young adults | 0 percentage of participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PR in children and young adults | 0 percentage of participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PD in children and young adults | 0 percentage of participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | CR in children and young adults | 100 percentage of participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PR in children and young adults | 0 percentage of participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | CR in children and young adults | 90.5 percentage of participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | SD in children and young adults | 0 percentage of participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PD in children and young adults | 9.5 percentage of participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | SD in children and young adults | 0 percentage of participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PD in children and young adults | 0 percentage of participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | CR in children and young adults | 100 percentage of participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PR in children and young adults | 0 percentage of participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | CR in children and young adults | 100 percentage of participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PR in children and young adults | 0 percentage of participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | SD in children and young adults | 0 percentage of participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | PD in children and young adults | 0 percentage of participants |
Secondary
Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells
Number of participants that have the targeted dose number of CAR cells successfully manufactured (i.e., number of participants enrolled where the correct number of cells are produces at the dose level that are enrolled) as measured by total number of viable cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) transduced T cells.
Time frame: CAR infusion (Day 0)
Population: 16/54 participants were not treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 4 Participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 4 Participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 5 Participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 2 Participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 1 Participants |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 21 Participants |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 1 Participants |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 1 Participants |
Secondary
Overall Survival
Overall survival (OS) will be determined as the time from the date of chimeric antigen receptor (CAR) infusion until death.
Time frame: Number of months from CAR cell infusion until date of death or time of censor (max 66.6 months)
Population: 16/54 participants were not treated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Overall Survival | 12.2 Months |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Overall Survival | 17.8 Months |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Overall Survival | 45.4 Months |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Overall Survival | 15.3 Months |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Overall Survival | 60 Months |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Overall Survival | 20.7 Months |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Overall Survival | 9.2 Months |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Overall Survival | 8.3 Months |
Secondary
Progression-free Survival (PFS)
PFS is assessed from the date of chimeric antigen receptor (CAR) infusion until the documentation of disease progression or death due to any cause, whichever occurs first. Disease progression was assessed by the Response Criteria Lymphoma and is defined as individual node/lesion must be abnormal with LDI\>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in longest transverse diameter of a lesion (LDI) or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions \> 2 cm; and the International Working Group and is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts.
Time frame: Number of months from CAR cell infusion until time of disease progression, death, or date of censor (up to 67 months)
Population: 16/54 participants were not treated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 6.4 Months |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 2.6 Months |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 20.1 Months |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 5.3 Months |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 60 Months |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Progression-free Survival (PFS) | 14.2 Months |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Progression-free Survival (PFS) | 5.7 Months |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Progression-free Survival (PFS) | 8.3 Months |
Other Pre-specified
Number of Participants With a Dose-limiting Toxicity (DLT)
A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion.
Time frame: First 28 days
Population: 16/54 participants were not treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 1 Participants |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 2 Participants |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Number of Participants With a Dose-limiting Toxicity (DLT) | 0 Participants |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Adverse Events were monitored/assessed from the first study intervention, Study Day -4, through day 30 after the study agent (s) was/were administered, an average of 5 weeks.
Population: 16/54 participants were not treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 4 Participants |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 4 Participants |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 4 Participants |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 2 Participants |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 1 Participants |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 21 Participants |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 1 Participants |
| GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 1 Participants |