Actively Recruiting
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
Eligibility Criteria
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
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
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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