RecruitingPhase 1NCT04795882

A New Study Evaluating the Activity of Modular CAR T for mYeloma

An Open Label, Phase 1 Study Evaluating the Activity of Modular CAR T for mYeloma


Sponsor

University College, London

Enrollment

27 participants

Start Date

Apr 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy called "modular CAR-T" for people with multiple myeloma — a blood cancer affecting plasma cells — whose disease has relapsed or stopped responding to multiple previous treatments. CAR-T therapy takes the patient's own immune cells, reprograms them in a lab, and infuses them back to fight the cancer. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma - You have received at least 3 prior lines of therapy (including a proteasome inhibitor, an IMiD drug, and an anti-CD38 antibody) - Your cancer is producing measurable levels of myeloma protein - Your disease is refractory to your most recent treatment - You have had or are ineligible for a stem cell transplant **You may NOT be eligible if...** - You have not received enough prior lines of therapy - Your cancer is not producing measurable myeloma protein - Your overall health does not meet the fitness criteria for cell therapy 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

BIOLOGICALBCMA CAR T cells

Infusion with ATIMP: BCMA CAR T-cells

BIOLOGICALBCMA/CD19 CAR T cells

Infusion with ATIMP: BCMA/CD19 CAR T-cells


Locations(1)

University College London Hospital

London, County (Optional), United Kingdom

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NCT04795882


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