NCT06218602

Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.

Detailed description

Primary Objectives 1. 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 2. To assess the response in participants 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 1. To assess PFS and OS among participants with and without FMT. 2. To assess changes in gut microbiome of lymphoma participants after FMT. 3. To assess dynamic changes in serum and stool metabolites after FMT.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	Given by PO
PROCEDURE	Chemotherapy	Given by Infusion
PROCEDURE	CAR-T Therapy	Given by Infusion

Timeline

• Start date: 2024-02-19
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-01-23
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study