RecruitingPhase 1Phase 2NCT07032129

Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma

Sponsor

Essen Biotech

Enrollment

60 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Multiple Myeloma in Relapse Multiple Myeloma, Refractory Multiple Myeloma Progression

Summary

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed/ Refractory Multiple myeloma

Eligibility

Min Age: 21 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment using two types of specially engineered immune cells (CAR-T cells) given one after another to fight multiple myeloma — a cancer of plasma cells in the bone marrow — in patients where standard treatments have stopped working. **You may be eligible if...** - You have relapsed or refractory multiple myeloma (it came back or didn't respond to treatment) - You have failed standard treatment options - Your expected survival is at least 3 months - You have adequate organ function **You may NOT be eligible if...** - You have active infections or certain autoimmune conditions - You have not failed prior standard therapies - Your overall health does not meet the study's requirements 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/GPRC5D CAR-T cells

The intervention in this clinical trial involves a novel approach using BCMA/GPRC5D Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. BCMA/GPRC5D Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, BCMA/GPRC5D CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial BCMA/GPRC5D CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.