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

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

Trial Details

NCT ID
NCT07042438
Phase
PHASE2
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Axicabtagene Ciloleucel
  • Biospecimen Collection
  • Chemotherapy
  • Fecal Microbiota Transplantation
  • Leukapheresis
  • Placebo Administration
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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