OncoMatch/Clinical Trials/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
Is NCT07042438 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Axicabtagene Ciloleucel and Chemotherapy for recurrent diffuse large b-cell lymphoma.
Treatment: Axicabtagene Ciloleucel · Chemotherapy — 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 patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Part of the treatment for CAR T therapy involves high doses of chemotherapy. This, along with prior exposure to high strength antibiotics, can damage patient's intestinal microbiota. Giving fecal microbiome transplantation may improve clinical response by repairing intestinal microbiota for patients with relapsed or refractory lymphoma who had exposure to high-risk antibiotics.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression
relapsed/refractory CD19 B-cell lymphomas
Allowed: MYC rearrangement
high grade B-cell lymphoma with MYC and BCL2 or BCL6 rearrangements
Allowed: BCL2 rearrangement
high grade B-cell lymphoma with MYC and BCL2 or BCL6 rearrangements
Allowed: BCL6 rearrangement
high grade B-cell lymphoma with MYC and BCL2 or BCL6 rearrangements
Prior therapy
Must have received: CAR-T cell therapy (YESCARTA) — scheduled to receive
scheduled to receive commercial CAR T treatment of YESCARTA ® for their diagnosis
Must have received: high-risk antibiotics (carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime), anaerobic antibiotics (metronidazole, clindamycin, amoxicillin-sulbactam, vancomycin)) — within 90 days of consent
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
Lab requirements
Blood counts
Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of Hope
Kidney function
Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of Hope
Liver function
Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of Hope
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify