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

Launched by CITY OF HOPE MEDICAL CENTER · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called fecal microbiome transplantation (FMT) can help improve outcomes for patients with certain types of lymphoma—a cancer of the lymphatic system—that have come back or have not responded to previous treatments. These patients have also received strong antibiotics that might have harmed the helpful bacteria in their intestines. FMT involves giving healthy bacteria from a donor’s stool to the patient to restore a balanced and protective community of gut bacteria. The trial is being done alongside a special cancer treatment called CAR T-cell therapy, where the patient’s own immune cells are modified to better fight their cancer.

Adults aged 18 and older with specific types of lymphoma who are about to receive CAR T-cell therapy and have recently taken high-risk antibiotics may be eligible to join. Participants will need to be in generally good health aside from their cancer and agree to certain safety checks, including tests for infections and pregnancy. During the study, patients will receive the fecal transplant as capsules to help rebuild their gut bacteria, alongside their CAR T-cell treatment. This trial is not yet recruiting, but it aims to see if restoring gut health can make cancer treatments more effective and improve patients’ responses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented informed consent of the participant and/or legally authorized representative.
• • Assent, when appropriate, will be obtained per institutional guidelines
• • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• • If unavailable, exceptions may be granted with study principal investigator (PI) approval
• • Age: ≥ 18 years
• • Karnofsky performance status (KPS) ≥ 60
• • Confirmed diagnosis of relapsed/refractory CD19 B-cell lymphomas of diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), or double-hit lymphoma (DHL) and scheduled to receive commercial CAR T treatment of YESCARTA ® for their diagnosis
• • Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
• • Exposure to high-risk antibiotics within 90 days of consent. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam, and vancomycin
• • Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of hope: (To be performed within 30 days prior to leukapheresis)
• • Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative)
• • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• • Meets other institutional and federal requirements for infectious disease titer requirements
• • Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
• • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
• • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• • Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 12 months after the last dose of protocol therapy.
• • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
• Exclusion Criteria:
• • Major surgery in 4 months preceding enrollment
• • No live vaccine in 30 days prior to enrollment
• • Inability to swallow capsules or history of disorder with Inability to swallow FMT capsules
• • History of inflammatory bowel disorder, irritable bowel disorder
• • Severe food allergies
• • History of chronic aspiration
• • History of behavioral disorders including substance abuse disorders which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment
• • History neurocognitive disorder which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment
• • Diagnosis of primary immunodeficiency
• • Active second malignancy requiring treatment except non-melanoma skin cancer or carcinoma in situ-cervix, bladder or to non-metastatic prostate cancer which does not require treatment
• • Uncontrolled bacterial, fungal, or viral infection confirmed using clinical, laboratory and radiological findings requiring administration of intravenously (IV) antimicrobials
• • Any clinical, laboratory or radiologic findings per discretion of primary investigator will interfere with safe conduct of study treatment and compliance with study procedures
• • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)