A Phase 1 interventional study of CD19/CD22 CAR T-Cells and Fludarabine in Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, B Cell and B-Cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 3 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
...
Background:
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:
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
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:
creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal.
Contraception:
--Individuals of child-bearing or child-fathering potential (IOCBP or IOCFP) must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the preparative regimen for IOCBP and for 4 months after receiving the preparative regimen for IOCFP
EXCLUSION CRITERIA:
Subjects meeting any of the following criteria are not eligible for participation in the study:
Subjects will be excluded related to the following prior therapy criteria:
Systemic chemotherapy, anti-neoplastic investigational agents, or antibody-based therapies =\<2 weeks (6 weeks for clofarabine or nitrosoureas) prior to apheresis with the following exception:
---No time restriction with prior intrathecal chemotherapy, steroid therapy, hydroxyurea or ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Philadelphia chromosome (Ph)+ ALL) provided there is recovery from any acute toxic effects.
Radiation therapy =\<3 weeks prior to apheresis with the following exception:
---No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the subject has measurable/evaluable disease outside the radiation window.
History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
History of prior CAR therapy or other adoptive cell therapies prior to apheresis that meet the following criteria:
Human Immunodeficiency Virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) Infection:
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at escalating doses.
Biological: CD19/CD22 CAR T-Cells · Drug: Fludarabine · Drug: Cyclophosphamide · Procedure: Apheresis · Other: Anti-emetic · Drug: Diphenhydramine · Drug: Acetaminophen · Diagnostic Test: ECG · Diagnostic Test: ECHO · Diagnostic Test: MRI Brain · Procedure: Bone marrow biopsy · Diagnostic Test: Cardiac MRI
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at maximum tolerated dose (MTD) or highest dose administered.
Biological: CD19/CD22 CAR T-Cells · Drug: Fludarabine · Drug: Cyclophosphamide · Procedure: Apheresis · Other: Anti-emetic · Drug: Diphenhydramine · Drug: Acetaminophen · Diagnostic Test: ECG · Diagnostic Test: ECHO · Diagnostic Test: MRI Brain · Procedure: Bone marrow biopsy · Diagnostic Test: Cardiac MRI
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.
Also known as: cluster of differentiation 19 chimeric antigen receptor T-cells, cluster of differentiation 22 chimeric antigen receptor T-cells
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.
Also known as: Fludara
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.
Also known as: Cytoxan
According to institutional standards.
Prophylaxis and treatment.
Pre-medication: 0.5-1 mg/kg/dose (maximum 50 mg/dose) by mouth or intravenous over 10-15 minutes.
Also known as: Benadryl, Banophen, Nytol
Pre-medication: 15 mg/kg/dose (maximum 650 mg/dose by mouth).
Also known as: Tylenol, ofirmev, FeverAll
Pre-cell infusion.
Also known as: Electrocardiogram
Pre-cell infusion.
Also known as: Echocardiogram
Pre-cell infusion.
Also known as: Magnetic resonance imaging
Pre-cell infusion.
Also known as: BM biopsy
Screening
Also known as: Cardiac magnetic resonance imaging
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).
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
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)
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)
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)
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
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
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.
| Milestone | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 5 | 2 | 1 | 0 | 0 | 0 | 8 |
| Completed | 4 | 4 | 4 | 2 | 1 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 |
| Withdrew: Not treated - participant did not receive cell infusion. | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 |
| Milestone | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 21 | 1 | 1 | 7 |
| Completed | 0 | 0 | 0 | 0 | 0 | 21 | 1 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Withdrew: Not treated - screen failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
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.
| toxicities | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) |
|---|---|---|---|---|---|---|---|---|
| Grade 3 Anemia | 2 | 2 | 1 | 1 | 1 | 13 | 1 | 0 |
| Grade 3 Febrile neutropenia | 1 | 2 | 1 | 1 | 1 | 13 | 0 | 0 |
| Grade 3 Sinus tachycardia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Abdominal pain | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Diarrhea | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Gastric hemorrhage | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Fever | 1 | 2 | 0 | 0 | 1 | 3 | 0 | 0 |
| Grade 3 Cytokine release syndrome | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 |
| Grade 3 Immune system disorders, other (GVHD) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Sepsis | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Alanine aminotransferase | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 3 Aspartate aminotransferase | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Grade 3 GGT increased | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Lymphocyte count decreased | 2 | 2 | 4 | 2 | 1 | 13 | 1 | 1 |
| Grade 3 Neutrophil count decreased | 3 | 2 | 3 | 2 | 0 | 17 | 1 | 1 |
| Grade 3 Platelet count decreased | 4 | 1 | 0 | 2 | 0 | 8 | 1 | 0 |
| Grade 3 White blood cell decreased | 3 | 0 | 3 | 2 | 0 | 16 | 1 | 0 |
| Grade 3 Anorexia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Hypertriglyceridemia | 2 | 1 | 0 | 0 | 0 | 3 | 0 | 0 |
| Grade 3 Hypocalcemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Hypokalemia | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 |
| Grade 3 Back pain | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Myalgia | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Grade 3 Dysphasia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Encephalopathy | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Headache | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Nervous system disorder, other (ICANS) | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 3 Nervous system disorder, other (Neurotoxicity) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Seizure | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 3 Hypoxia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Hypertension | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Hypotension | 0 | 2 | 0 | 1 | 0 | 6 | 0 | 0 |
| Grade 4 Anemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Grade 4 Fibrinogen decreased | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 4 Lymphocyte count decreased | 3 | 3 | 4 | 2 | 1 | 17 | 1 | 1 |
| Grade 4 Neutrophil count decreased | 3 | 1 | 2 | 2 | 0 | 14 | 1 | 0 |
| Grade 4 Platelet count decreased | 2 | 1 | 0 | 0 | 1 | 6 | 1 | 0 |
| Grade 4 White blood cell decreased | 3 | 2 | 0 | 1 | 0 | 10 | 1 | 0 |
| Grade 4 Hypertriglyceridemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 4 Hypokalemia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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.
| 10^6 CAR T cells/kg | All Participants |
|---|---|
| Maximum Tolerated Dose (MTD) | 3 |
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.
| Participants | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | 4 | 4 | 5 | 2 | 1 | 21 | 1 | 1 |
Overall survival (OS) will be determined as the time from the date of chimeric antigen receptor (CAR) infusion until death.
| Months | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) |
|---|---|---|---|---|---|---|---|---|
| Overall Survival | 12.2 (8.9 to 27.8) | 17.8 (10.9 to 68.5) | 45.4 (13 to 66.6) | 15.3 (10.1 to 20.5) | 60 (60 to NA) | 20.7 (3 to 50.9) | 9.2 (9.2 to NA) | 8.3 (8.3 to NA) |
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.
| Months | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) |
|---|---|---|---|---|---|---|---|---|
| Progression-free Survival (PFS) | 6.4 (0.9 to 11.9) | 2.6 (1.0 to 8.6) | 20.1 (0.9 to 66.6) | 5.3 (2.4 to 8.1) | 60 (60 to NA) | 14.2 (0.9 to 50.9) | 5.7 (5.7 to NA) | 8.3 (8.3 to NA) |
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.
| percentage of participants | GROUP 4:Cohort 1A, CAR Naïve or CAR Pretreated With Interval Hematopoietic Stem Cell Transplantation | GROUP 5: Cohort 1B, Previously Received Chimeric Antigen Receptor (CAR) Participants | GROUP 6:Cohort 2A, CAR Naïve or CAR Pretreated With Interval Hematopoietic Stem Cell Transplantation | GROUP 7: Cohort 2B, Previously Received Chimeric Antigen Receptor (CAR) | Group 8:Cohort 2C, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation |
|---|---|---|---|---|---|
| CR in children and young adults | 50 (2.6 to 97.4) | 100 (5.1 to 100) | 90.5 (71.1 to 98.3) | 100 (5.1 to 100) | 100 (5.1 to 100) |
| PR in children and young adults | 50 (2.6 to 97.4) | 0 (0 to 94.9) | 0 (0 to 15.5) | 0 (0 to 94.9) | 0 (0 to 94.9) |
| SD in children and young adults | 0 (0 to 82.2) | 0 (0 to 94.9) | 0 (0 to 15.5) | 0 (0 to 94.9) | 0 (0 to 94.9) |
| PD in children and young adults | 0 (0 to 82.2) | 0 (0 to 94.9) | 9.5 (1.7 to 28.9) | 0 (0 to 94.9) | 0 (0 to 94.9) |
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.
| Participants | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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 x10^6 Transduced T Cells/kg (+Or- 20%) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With a Dose-limiting Toxicity (DLT) | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 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.
| Participants | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 4 | 4 | 4 | 2 | 1 | 21 | 1 | 1 |
Collected over All-Cause Mortality was monitored/assessed an average of 35 days. Adverse Events were monitored/assessed from the first study intervention (Study Day -4, through day 30 after the study agent (s) was/were administered) in any cycle, an average of 5 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 4/4 (100%) | 2/4 (50%) | 4/4 (100%) |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 3/4 (75%) | 2/4 (50%) | 4/4 (100%) |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 2/4 (50%) | 0/4 (0%) | 4/4 (100%) |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 8/21 (38.1%) | 7/21 (33.3%) | 21/21 (100%) |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Group 8:Cohort 2C, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Event | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation |
|---|---|---|---|---|---|---|---|---|
| Nervous system disorders - Other, (Neurotoxicity)Nervous system disorders | 0/4 | 0/4 | 0/4 | 0/2 | 1/1 | 0/21 | 0/1 | 0/1 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/4 | 0/4 | 0/4 | 0/2 | 0/1 | 0/21 | 0/1 | 1/1 |
| Cytokine release syndromeImmune system disorders | 1/4 | 2/4 | 0/4 | 1/2 | 0/1 | 1/21 | 0/1 | 0/1 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/4 | 1/4 | 0/4 | 1/2 | 0/1 | 0/21 | 0/1 | 0/1 |
| HypotensionVascular disorders | 0/4 | 0/4 | 0/4 | 1/2 | 0/1 | 1/21 | 0/1 | 0/1 |
| Immune system disorders - Other, GVHDImmune system disorders | 0/4 | 0/4 | 0/4 | 1/2 | 0/1 | 0/21 | 0/1 | 0/1 |
| FeverGeneral disorders | 0/4 | 1/4 | 0/4 | 0/2 | 0/1 | 3/21 | 0/1 | 0/1 |
| Flu like symptomsGeneral disorders | 1/4 | 0/4 | 0/4 | 0/2 | 0/1 | 0/21 | 0/1 | 0/1 |
| HypertensionVascular disorders | 1/4 | 0/4 | 0/4 | 0/2 | 0/1 | 0/21 | 0/1 | 0/1 |
| Upper respiratory infectionInfections and infestations | 1/4 | 0/4 | 0/4 | 0/2 | 0/1 | 0/21 | 0/1 | 0/1 |
| Event | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation |
|---|---|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 2/4 | 2/4 | 2/4 | 2/2 | 1/1 | 10/21 | 0/1 | 0/1 |
| Activated partial thromboplastin time prolongedInvestigations | 1/4 | 1/4 | 2/4 | 1/2 | 1/1 | 9/21 | 1/1 | 0/1 |
| AgitationPsychiatric disorders | 0/4 | 0/4 | 0/4 | 0/2 | 1/1 | 0/21 | 1/1 | 0/1 |
| Alanine aminotransferase increasedInvestigations | 2/4 | 3/4 | 2/4 | 2/2 | 1/1 | 9/21 | 0/1 | 1/1 |
| Alkaline phosphatase increasedInvestigations | 1/4 | 2/4 | 2/4 | 0/2 | 0/1 | 5/21 | 1/1 | 0/1 |
| AnemiaBlood and lymphatic system disorders | 4/4 | 4/4 | 4/4 | 2/2 | 1/1 | 19/21 | 1/1 | 1/1 |
| AnorexiaMetabolism and nutrition disorders | 3/4 | 2/4 | 3/4 | 2/2 | 0/1 | 13/21 | 1/1 | 0/1 |
| AnxietyPsychiatric disorders | 1/4 | 2/4 | 2/4 | 2/2 | 1/1 | 10/21 | 0/1 | 1/1 |
| Aspartate aminotransferase increasedInvestigations | 3/4 | 2/4 | 0/4 | 2/2 | 1/1 | 13/21 | 1/1 | 1/1 |
| Back painMusculoskeletal and connective tissue disorders | 0/4 | 1/4 | 3/4 | 1/2 | 1/1 | 13/21 | 0/1 | 0/1 |
Data collected for participants enrolled and not treated are reported here.
| Age, Categorical(Participants) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 1 | 0 | 2 | 0 | 1 | 8 | 1 | 0 | 5 | 18 |
| Between 18 and 65 years | 3 | 4 | 3 | 2 | 0 | 13 | 0 | 1 | 10 | 36 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 15.88 ± 6.06 | 24.75 ± 3.97 | 19.12 ± 8.73 | 25.75 ± 3.45 | 9.7 ± 0 | 21 ± 10.86 | 18.2 ± 0 | 22.6 ± 0 | 21.75 ± 10.91 | 20.69 ± 10.09 |
| Sex: Female, Male(Participants) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 0 | 2 | 1 | 1 | 9 | 1 | 0 | 6 | 21 |
| Male | 3 | 4 | 3 | 1 | 0 | 12 | 0 | 1 | 9 | 33 |
| Ethnicity (NIH/OMB)(Participants) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 2 | 0 | 0 | 12 | 0 | 1 | 6 | 24 |
| Not Hispanic or Latino | 3 | 2 | 3 | 2 | 1 | 9 | 1 | 0 | 7 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Asian | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 4 |
| White | 2 | 2 | 3 | 1 | 1 | 11 | 1 | 1 | 9 | 31 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 1 | 0 | 0 | 6 | 0 | 0 | 3 | 13 |
| Region of Enrollment(participants) | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 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%) | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| United States | 4 | 4 | 5 | 2 | 1 | 21 | 1 | 1 | 15 | 54 |
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Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Supporting information: Study protocol, Sap, Icf
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