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RECRUITING
NCT07042438
PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial tests how well fecal microbiome transplantation works to remodel intestinal microbiota for patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) with exposure to high-risk antibiotics who are receiving chimeric antigen receptor (CAR) T cells. Fecal microbiome transplantation consists of fecal microbiota from healthy donors with healthy gut microbiota that allows re-population of the patient's microbiome with diverse protective microorganisms. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Part of the treatment for CAR T therapy involves high doses of chemotherapy. This, along with prior exposure to high strength antibiotics, can damage patient's intestinal microbiota. Giving fecal microbiome transplantation may improve clinical response by repairing intestinal microbiota for patients with relapsed or refractory lymphoma who had exposure to high-risk antibiotics.

Official title: A Phase 2 Randomized Trial of Remodeling Intestinal Microbiota Using Fecal Microbiome Transplant (FMT) Among Recipients of Chimeric Antigen Receptor T Cells (CAR T)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-02-11

Completion Date

2029-01-23

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

Given CAR-T cells

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Chemotherapy

Receive chemotherapy

PROCEDURE

Fecal Microbiota Transplantation

Given PO

PROCEDURE

Leukapheresis

Undergo leukapheresis

DRUG

Placebo Administration

Given PO

Locations (1)

City of Hope Medical Center

Duarte, California, United States