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CAR T-cell Therapy
CD19.CAR-multiVST for Group A for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Rayne H Rouce, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-8 weeks
Awards & highlights
Study Summary
CD19.CAR-multiVSTs for Patients With CD19+ B-ALL or NHL Undergoing Related Allogeneic HSCT (CARMA)
Eligible Conditions
- Non-Hodgkin's Lymphoma
- Acute Lymphoblastic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients with Dose-Limiting Toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary outcome measures
Overall response rate according to RECIST criteria.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CD19.CAR-multiVST for Group BExperimental Treatment1 Intervention
Group B: Patients with evidence of disease before bone marrow transplant OR have relapsed after bone marrow transplant.
Patients in Group B will receive the T cells at the earliest feasible time point after the detection of disease, but no earlier than day 30 after the transplant. The three dose levels will be studied in both groups of patients (Group A and Group B). The lowest dose level will be 2 x 10^7cells/m2 and the highest will be 10 x10^7cells/m2.
Group II: CD19.CAR-multiVST for Group AExperimental Treatment1 Intervention
Group A: Patients with no evidence of disease after having a bone marrow transplant.
T cells will be given at the specified dose on or after day 30 after the bone marrow transplant. Three dose levels will be studied in both groups of patients (Group A and Group B). The lowest dose level will be 2 x 10^7cells/m2 and the highest will be 10 x10^7cells/m2.
Find a Location
Who is running the clinical trial?
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,817 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,180 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,375 Total Patients Enrolled
Frequently Asked Questions
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