RecruitingPhase 1Phase 2NCT06644443

BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma

BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma:A Prospective, Single-center, Single-arm Phase I/IIa Clinical Trial


Sponsor

Shenzhen University General Hospital

Enrollment

10 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy targeting two proteins (BCMA and GPRC5D) found on myeloma cells, for patients with multiple myeloma that has returned or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have relapsed or refractory multiple myeloma that has not responded to regimens including bortezomib or lenalidomide - Your cancer cells test positive for BCMA and GPRC5D proteins - You have measurable disease detectable in blood, urine, or bone marrow - You are in reasonably good health (ECOG score 0–2) - You have not received cancer treatment in the weeks prior to cell therapy **You may NOT be eligible if...** - You have a known allergy to components of the cell product - Your liver, kidney, or blood counts fall below required levels (e.g., hemoglobin below 80 g/L, high bilirubin, or elevated creatinine) - You are pregnant or breastfeeding - You have contraindications to the blood collection procedure (apheresis) 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

patient was subjected to 2-5×10\^6 BCMA-GPRC5D CAR-T cells/kg


Locations(1)

Shenzhen University General Hospital

Shenzhen, Guangdong, China

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NCT06644443


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