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Fecal Microbiome Transplant for Lymphoma Patients Receiving CAR T-cells

This study is looking at how well fecal microbiome transplantation (FMT) can help patients with lymphoma that has returned or isn't responding to treatment, especially if they've had strong antibiotics. These patients are also receiving a type of immunotherapy called CAR T-cell therapy (Axicabtagene Ciloleucel), where their own immune cells are specially trained to fight cancer. FMT involves receiving healthy gut bacteria from a donor to help restore a healthy balance in your gut. The main goal is to see how FMT changes the variety of bacteria in your gut before you get CAR T-cells. The study also aims to see how effective CAR T-cell therapy is and to check for any side effects from FMT. This study is currently recruiting 56 participants.

Study design
This is an interventional study with a planned enrollment of 56 participants. It is a Phase II trial.
What's involved
You would undergo leukapheresis (a procedure to collect your blood cells), receive chemotherapy, and then be given Axicabtagene Ciloleucel (CAR T-cells). You would also receive Fecal Microbiota Transplantation orally and have blood samples collected.
Compensation
Not stated in the trial record.
Follow-up
The study will track changes in your gut microbiome from the start until the day of CAR T infusion. It will also estimate response rates at 30 days, 90 days, and 1 year after CAR T therapy, and monitor for side effects for up to 28 days after the last FMT dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~56 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Axicabtagene CiloleucelBiospecimen CollectionChemotherapyFecal Microbiota TransplantationLeukapheresisPlacebo Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in gut microbiome diversity
Measured over From baseline to day 0

Conditions

Recurrent Diffuse Large B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh Grade B-Cell LymphomaCD19 Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Karamjeet S Sandhu · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Karamjeet S. Sandhu
[email protected]
626-218-2405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Changes in gut microbiome diversityFrom baseline to day 0

    Assessed using the Shannon alpha diversity index. For comparisons at a timepoint of most interest, a t-test (or Wilcoxon rank-sum test if assumptions are not met) will be used to compare the Shannon index between the fecal microbiome transplant (FMT) and placebo groups. For over-time comparisons, linear mixed models will be used to assess longitudinal changes in microbiome diversity between treatment (FMT) and control (placebo) groups, accounting for within-subject correlations over multiple measurement points.