RecruitingPhase 1NCT07340853

CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma

A Phase 1b Clinical Trial of CRISPR Delivered Anti-BCMA Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Multiple Myeloma


Sponsor

Thomas Martin, MD

Enrollment

30 participants

Start Date

Feb 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety, side effects and best dose of clustered regularly interspaced short palindromic repeats (CRISPR) delivered anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells (1XX BCMA CAR-T cells) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Anti-BCMA CAR-T cell therapy is a type of treatment in which a person'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, such as BCMA, on the patient's cancer cells is added to the T cells in the laboratory by a tool called clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9. The special receptor is called a 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 before CAR-T cells may decrease the number of lymphocytes (a type of white blood cells) in the blood and may help the 1XX BCMA CAR-T cells fight the cancer cells. Treatment with 1XX BCMA CAR-T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma (RRMM).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CRISPR-engineered CAR-T cell therapy targeting a protein called BCMA in people with multiple myeloma (a blood cancer) that has stopped responding to standard treatments. CAR-T therapy involves modifying a patient's own immune cells to seek out and destroy cancer cells. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma and have relapsed or become refractory (not responding) to treatment - You have received at least 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody - If you previously received BCMA-targeted therapy, at least 6 months have passed since your last dose - Your cancer is still measurable - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have not received the minimum required prior treatments - Your health is too poor to tolerate the procedure - Your cancer is progressing too rapidly for the apheresis-to-infusion timeline 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

PROCEDURELeukapheresis

Undergo Leukapheresis

DRUGCyclophosphamide

Given Intravenously (IV)

BIOLOGICALChimeric Antigen Receptor T cells (CAR-T) Targeting BCMA

Given Intravenously (IV)

BEHAVIORALQuality of Life (QoL) Questionnaires

Ancillary studies

PROCEDUREBone Marrow Biopsy

Undergo biopsy

BIOLOGICALBiospecimen Collection

Undergo Blood, serum and urine collection

DRUGFludarabine

Given IV

PROCEDURERadiographic imaging

Undergo radiographic imaging


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT07340853


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