RecruitingPhase 2NCT07042438

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

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


Sponsor

City of Hope Medical Center

Enrollment

56 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fecal microbiome transplant (FMT) — transferring healthy gut bacteria from a donor into a patient — can improve the effectiveness of CAR T-cell therapy in people with relapsed or treatment-resistant lymphoma who have recently taken antibiotics. Certain antibiotics can disrupt gut bacteria, which may reduce how well CAR T-cell therapy works. This study aims to restore that balance before treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma, or double-hit lymphoma - You are scheduled to receive CAR T-cell therapy - You recently received antibiotics considered high-risk for disrupting gut bacteria - Your overall performance status is adequate (Karnofsky ≥60) **You may NOT be eligible if...** - You have not been exposed to the specific high-risk antibiotics - You have active serious infections - Your organ function does not meet the required levels - You have other major health conditions that would make this study unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAxicabtagene Ciloleucel

Given CAR-T cells

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGChemotherapy

Receive chemotherapy

PROCEDUREFecal Microbiota Transplantation

Given PO

PROCEDURELeukapheresis

Undergo leukapheresis

DRUGPlacebo Administration

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07042438


Related Trials