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NCT07042438 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 2
Development phase
56
Enrollment target
1
Study location

NCT07042438 is a Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 56 participants, above the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT07042438, a Phase 2 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 2
Development phase
56 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • DRUG Chemotherapy
  • PROCEDURE Fecal Microbiota Transplantation
  • PROCEDURE Leukapheresis
  • BIOLOGICAL Axicabtagene Ciloleucel

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2026-02-11
Est. Completion 2029-01-23
Phase Phase 2

Sponsor

City of Hope Medical Center

582 total trials

What the Registry Record Tells You About NCT07042438

The ClinicalTrials.gov registry entry for NCT07042438 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (19% higher). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07042438 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT07042438 about?

NCT07042438 is a clinical study titled "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 receivin...

What is the current status of trial NCT07042438?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2026-02-11. Estimated completion is 2029-01-23.

What conditions does trial NCT07042438 study?

This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory 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 High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements.

What interventions are being tested in trial NCT07042438?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Chemotherapy (DRUG), Fecal Microbiota Transplantation (PROCEDURE), Leukapheresis (PROCEDURE), Axicabtagene Ciloleucel (BIOLOGICAL).

Who is sponsoring clinical trial NCT07042438?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07042438 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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