This phase II trial evaluates whether fecal microbiota transplantation (FMT) around the time of standard of care chemotherapy and chimeric antigen receptor (CAR) T-cell therapy is effective at reducing gut-related side effects and improving treatment outcomes in patients with B-cell lymphoma who recently received antibiotics. The use of antimicrobials may reduce the number and types of good bacteria in the gut. Research has shown that exposure to broad-spectrum antibiotics prior to CAR T-cell therapy is associated with poor outcomes and toxicities. FMT involves the transplantation of the good, healthy fecal bacteria that would otherwise naturally occur in the body from a healthy individual to a recipient. The fecal matter can be transplanted via colonoscopy or enema or can be put into a capsule to be swallowed. FMT may be safe, tolerable and/or effective in reducing gut-related side effects and improving treatment outcomes in patients with B-cell lymphoma receiving CAR T-cell therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06218602.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Neeraj Saini
Phone: 832-373-7146
PRIMARY OBJECTIVES:
I. To assess the toxicity of combination of FMT with anti-CD19 axicabtagene ciloleucel therapy and compare it with standard of care arm B with anti-CD19 CAR-T arm.
II. To assess the response in patients treated with the combination of FMT and axicabtagene ciloleucel CAR T-cell therapy at day 30 and compare it with standard of care arm B with anti-CD19 CAR-T arm.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) and overall survival (OS) and complete response (CR) endpoints among patients with and without FMT at 1,3,6 and 12 months.
II. To assess changes in gut microbiome of lymphoma patients after FMT.
III. To assess dynamic changes in serum and stool metabolites after FMT.
IV. To assess prevalence of peripheral blood cytopenias at day 30 post CAR-T cell infusion among patients with and without FMT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo FMT via enema between apheresis and day -12 prior to standard of care chemotherapy (days -5, -4, and -3) and standard of care CAR T-cell infusion (day 0). Patients then receive lyophilized fecal microbiota capsules orally (PO) on days 14, 21, and 28 post CAR T-cell infusion. Patients also undergo blood and stool sample collection and positron emission tomography (PET)/computed tomography (CT) scan throughout study.
ARM B: Patients receive standard of care chemotherapy (days -5, -4, and -3) and standard of care CAR T-cell infusion (day 0). Patients also undergo blood and stool sample collection and PET/ CT scan throughout study.
After completion of study intervention, patients are followed up for a minimum of 12 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorNeeraj Saini
