← Back to Search

CAR T-cell Therapy

CD19.CAR-multiVSTs for Patients With CD19+ B-ALL or NHL Undergoing Related Allogeneic HSCT (CARMA)

Houston, TX
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
No Placebo-Only Group

Summary

This study is for patients that are having a bone marrow or stem cell transplant for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called Non-Hodgkin's Lymphoma (NHL). Although a transplant can cure leukemia or lymphoma, some people will relapse (return of the disease). In those who relapse, current treatment cures only a very small percentage. This study is being conducted to evaluate the safety of a new type of therapy that may help to decrease the risk of relapse or treat relapse after it has occurred. The body has different ways of fighting infection and disease. This study combines two of those ways, antibodies and T cells. Antibodies are proteins that protect the body from bacterial and other diseases. T cells are infection-fighting blood cells that can kill other cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-CD19. This antibody is attracted to cancer cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor (also known as a CAR T cell). Although anti-CD19 antibodies or chimeric receptors can kill cancer cells, unfortunately they sometimes do not last long enough to destroy all of the cancer cells. These CD19 chimeric receptor multivirus specific T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to determine what the side effects are, to see how long the T cells last and to evaluate whether this therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma having a bone marrow transplant.

See full description
Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Dose-Limiting Toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary study objectives
Overall response rate according to RECIST criteria.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Closest Location:Houston Methodist Hosptial· Houston, TX· 993 miles

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
113 Previous Clinical Trials
2,934 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,041 Previous Clinical Trials
6,030,597 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
298 Previous Clinical Trials
82,509 Total Patients Enrolled
Rayne H Rouce, MDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
38 Total Patients Enrolled
~0 spots leftby Aug 2025