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NCT06191887 · ClinicalTrials.gov registry record · Phase 1

B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies

A Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 1
Development phase
27
Enrollment target
1
Study location

NCT06191887 is a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 27 participants, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06191887, a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by Mayo Clinic.

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

Study Summary

This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells 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. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Biopsy
  • PROCEDURE Bone Marrow Aspiration and Biopsy
  • DRUG Bendamustine
  • BIOLOGICAL Autologous BAFFR-targeting CAR T Cells

Study Locations (1)

Florida

  • Mayo Clinic in Florida - Jacksonville

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2024-03-18
Est. Completion 2040-12-31
Phase Phase 1

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT06191887

The ClinicalTrials.gov registry entry for NCT06191887 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (43% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 10 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.

NCT06191887 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT06191887 about?

NCT06191887 is a clinical study titled "B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies". This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a perio...

What is the current status of trial NCT06191887?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2024-03-18. Estimated completion is 2040-12-31.

What conditions does trial NCT06191887 study?

This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, B-Cell Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia.

What interventions are being tested in trial NCT06191887?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Bendamustine (DRUG), Autologous BAFFR-targeting CAR T Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT06191887?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06191887 being conducted?

This trial has 1 study location across Florida. 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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