Study on Fecal Microbiome Transplant for Patients with Relapsed or Hard-to-Treat Lymphoma Receiving CAR T-Cell Therapy

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07042438

Provider View

This clinical trial is exploring whether fecal microbiome transplantation can help improve gut health and treatment outcomes for patients with relapsed or refractory lymphoma who have been exposed to strong antibiotics and are receiving CAR T-cell therapy.

Patient Parameters

Program Overview

This study is investigating if fecal microbiome transplantation (FMT) can help restore healthy gut bacteria in patients with lymphoma that has returned or is not responding to treatment. These patients are receiving CAR T-cell therapy, a treatment where their immune cells are modified to attack cancer cells. The use of strong antibiotics and chemotherapy can harm gut bacteria, and FMT aims to repair this by introducing healthy bacteria from donors. The study will assess if this approach can improve treatment responses and overall health outcomes.

Description

The main goal of this study is to see if fecal microbiome transplant (FMT) can improve the diversity of gut bacteria in patients receiving CAR T-cell therapy for relapsed or refractory lymphoma. Researchers will measure changes in gut bacteria diversity and monitor treatment responses at various time points after CAR T therapy.

Participants will be divided into two groups. One group will receive FMT along with their standard CAR T-cell therapy, while the other group will receive a placebo. Both groups will undergo regular blood tests and health assessments throughout the study.

The study will also evaluate the safety of FMT, track any side effects, and measure how well the transplanted bacteria establish themselves in the gut. Researchers will also look at the overall response rates, survival rates, and any infections that occur after treatment.

Participants will be followed up at 28 days, 90 days, and one year after completing CAR T-cell therapy to assess long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must agree to allow the use of previous tumor biopsy samples.
  • Must be 18 years or older.
  • Must have a performance status score of 60 or higher, indicating the ability to care for oneself with some assistance.
  • Must have a confirmed diagnosis of certain types of relapsed or refractory lymphoma and be scheduled to receive CAR T-cell therapy.
  • Must have recovered from previous cancer treatments, except for hair loss.
  • Must have been exposed to certain high-risk antibiotics within 90 days before joining the study.
  • Must meet specific health criteria, including negative tests for HIV, hepatitis B, and hepatitis C.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 12 months after treatment.

Exclusion Criteria

  • Major surgery within the last 4 months.
  • Received a live vaccine within 30 days before joining the study.
  • Unable to swallow capsules or have a condition that prevents swallowing FMT capsules.
  • History of inflammatory or irritable bowel disorders.
  • Severe food allergies.
  • History of chronic aspiration.
  • Behavioral or neurocognitive disorders that may interfere with study participation.
  • Diagnosis of primary immunodeficiency.
  • Active second cancer requiring treatment, except for certain non-threatening cancers.
  • Uncontrolled infections requiring IV antibiotics.
  • Any condition that may interfere with safe participation in the study, as determined by the investigator.

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