Actively Recruiting
A Phase 2 Randomized Trial of Fecal Microbiome Transplant to Remodel Intestinal Microbiota in Patients Receiving CAR T-Cell Therapy for Relapsed or Refractory Lymphoma
Led by City of Hope Medical Center · Updated on 2026-03-05
56
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how fecal microbiome transplantation (FMT) may help repair the gut bacteria in patients with relapsed or refractory lymphoma who have been exposed to high-risk antibiotics and are receiving chimeric antigen receptor (CAR) T-cell therapy. This phase II trial studies whether restoring healthy gut microbiota through FMT can improve clinical response in these patients. CAR T-cell therapy involves modifying a patient's immune cells to better attack cancer, but this treatment and prior antibiotics can damage intestinal microbiota. Participants are randomly assigned to one of two groups. One group receives FMT orally at specific times before leukapheresis and CAR T-cell infusion, as well as after neutrophil recovery. The other group receives a placebo on the same schedule. Both groups undergo standard chemotherapy and CAR T-cell therapy. Treatment continues unless disease progresses or unacceptable side effects occur. Throughout the study, patients have blood samples collected for analysis. Researchers measure changes in gut microbiome diversity at the time of CAR T infusion and track responses at 30 days, 90 days, and 1 year. Safety is monitored through adverse event reporting up to one year post-therapy. Additional assessments include bacterial infection rates, immune responses, and overall survival. Follow-up visits occur at 28 days, 90 days, and 1 year after CAR T therapy.
CONDITIONS
Brief 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...
- Documented informed consent with assent when appropriate
- Agreement to allow use of archival tumor tissue or obtain approval if unavailable
- Age 18 years or older
- Karnofsky performance status of at least 60
- Confirmed diagnosis of relapsed/refractory CD19 B-cell lymphoma (DLBCL, transformed follicular lymphoma, or double-hit lymphoma)
- Scheduled to receive commercial CAR T-cell therapy (YESCARTA 4)
- Fully recovered from prior anti-cancer therapy toxic effects except alopecia (grade 1 or less)
- Exposure to high-risk broad-spectrum antibiotics within 90 days before consent
- Clinical laboratory and organ function criteria met per standard of care within 30 days before leukapheresis
- Negative tests for HIV, hepatitis C, and active hepatitis B (exceptions for controlled HIV patients)
- Women of childbearing potential must have negative pregnancy tests
- Agreement by males and females of childbearing potential to use effective birth control or abstain from heterosexual activity during and 12 months after study treatment
You will not qualify if you...
- Major surgery within 4 months before enrollment
- Live vaccine within 30 days before enrollment
- Inability to swallow capsules or history of swallowing disorder affecting FMT capsules
- History of inflammatory bowel disease or irritable bowel syndrome
- Severe food allergies
- History of chronic aspiration
- Behavioral disorders including substance abuse interfering with study compliance
- Neurocognitive disorders interfering with study compliance
- Diagnosis of primary immunodeficiency
- Active second malignancy requiring treatment except certain non-invasive cancers
- Uncontrolled infections requiring intravenous antimicrobials
- Any clinical, lab, or radiologic condition interfering with safe study participation
- Any condition judged by investigator to contraindicate participation due to safety
- Inability to comply with study procedures or logistics
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day -10 before leukapheresis until neutrophil recovery and 2 days after
Participants receive chemotherapy and CAR T-cell therapy. They take either fecal microbiota transplant (FMT) or placebo capsules on specific days before leukapheresis and CAR T infusion and around neutrophil recovery, while blood samples are collected throughout treatment.
Multiple visits including leukapheresis, CAR T infusion, and several dosing visits
Duration - Up to 1 year post CAR T cell therapy
Participants are followed up to monitor response to therapy, safety, and survival, including blood sample collections and assessment of adverse events.
Visits at day 28, day 90, and 1 year after CAR T cell therapy
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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