RecruitingPhase 1NCT06191887

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

Phase 1a/1b Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells (MC10029) in Subjects With Relapsed or Refractory BAFFR-Expressing B-Cell Hematologic Malignancies


Sponsor

Mayo Clinic

Enrollment

27 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy (immune cells engineered to find and destroy cancer cells) that targets a protein called BAFFR, for adults with B-cell blood cancers that have returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with one of the following B-cell cancers that has relapsed or not responded to prior treatment: CLL/SLL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, or large B-cell lymphoma (including Richter's transformation) - Your disease has been confirmed by biopsy or scan showing progression - You have adequate organ function **You may NOT be eligible if...** - You have active, uncontrolled infection - You have a history of severe autoimmune disease - You have uncontrolled heart, liver, or lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous BAFFR-targeting CAR T Cells

Given IV

DRUGBendamustine

Given IV

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy/aspirate

PROCEDUREComputed Tomography

Undergo CT scan

DRUGCyclophosphamide

Given IV

PROCEDUREEchocardiography

Undergo echocardiography

DRUGFludarabine

Given IV

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET scan


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06191887


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