Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07042438

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

Led by City of Hope Medical Center · Updated on 2026-03-05

56

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided documented informed consent (and assent if applicable)
  • Allowed use of archival tumor biopsy tissue or obtained PI approval if unavailable
  • Age 18 years or older
  • Karnofsky performance status of 60 or higher
  • Confirmed diagnosis of relapsed or refractory CD19 B-cell lymphoma (DLBCL, tFL, or DHL)
  • Scheduled to receive commercial CAR T-cell therapy (YESCARTA 4)
  • Fully recovered to grade 1 or less from prior anticancer therapy toxic effects (except alopecia)
  • Exposure to high-risk broad-spectrum antibiotics within 90 days before consent
  • Met clinical laboratory and organ function requirements within 30 days prior to leukapheresis
  • Seronegative or effectively managed HIV, hepatitis B and C as per protocol
  • Negative pregnancy test for women of childbearing potential
  • Agreed to use effective birth control or abstain from heterosexual activity during study and for 12 months after last dose
Not Eligible

You will not qualify if you...

  • Underwent major surgery within 4 months before enrollment
  • Received live vaccine within 30 days before enrollment
  • Unable to swallow capsules or history of swallowing disorder affecting FMT
  • History of inflammatory bowel disease or irritable bowel syndrome
  • Severe food allergies
  • History of chronic aspiration
  • Behavioral disorders including substance abuse that interfere with study compliance
  • Neurocognitive disorders interfering with study compliance
  • Diagnosis of primary immunodeficiency
  • Active second malignancy requiring treatment except certain skin, cervical, bladder, or non-metastatic prostate cancers
  • Uncontrolled bacterial, fungal, or viral infection requiring IV antimicrobial treatment
  • Any clinical, laboratory, or radiologic condition interfering with safe study conduct
  • Any other condition contraindicating participation due to safety concerns
  • Inability to comply with study procedures as judged by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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