Phase 2 Study of Fecal Microbiome Transplant to Improve Gut Microbiota in Adults with Relapsed or Refractory B-Cell Lymphoma Receiving CAR T-Cell Therapy

What this Trial Is About

Researchers are evaluating how fecal microbiome transplantation FMT may help repair the gut bacteria in patients with relapsed or refractory lymphoma who have been exposed to high-risk antibiotics and are receiving chimeric antigen receptor CAR T-cell therapy. This phase II trial studies whether restoring healthy gut microbiota through FMT can improve clinical response in these patients. CAR T-cell therapy involves modifying a patients immune cells to better attack cancer, but this treatment and prior antibiotics can damage intestinal microbiota. Participants are randomly assigned to one of two groups. One group receives FMT orally at specific times before leukapheresis and CAR T-cell infusion, as well as after neutrophil recovery. The other group receives a placebo on the same schedule. Both groups undergo standard chemotherapy and CAR T-cell therapy. Treatment continues unless disease progresses or unacceptable side effects occur. Throughout the study, patients have blood samples collected for analysis. Researchers measure changes in gut microbiome diversity at the time of CAR T infusion and track responses at 30 days, 90 days, and 1 year. Safety is monitored through adverse event reporting up to one year post-therapy. Additional assessments include bacterial infection rates, immune responses, and overall survival. Follow-up visits occur at 28 days, 90 days, and 1 year after CAR T therapy.

Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells