RecruitingPhase 1NCT05219721

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia


Sponsor

Chunrui Li

Enrollment

18 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy targeting a protein called GPRC5D for people with multiple myeloma or plasma cell leukemia that has returned or stopped responding to treatment. CAR-T therapy involves engineering your own immune cells in the lab to recognize and attack cancer cells. **You may be eligible if...** - You are 18–75 years old - You have had at least 3 prior lines of therapy for multiple myeloma or plasma cell leukemia, including a proteasome inhibitor and an immunomodulatory drug - Your myeloma cells test positive for the GPRC5D protein - You have measurable disease (detectable cancer markers in blood, urine, or bone marrow) - You are in reasonable physical condition (ECOG score of 0–2) - Your organ function meets the required levels **You may NOT be eligible if...** - You have had a prior organ transplant - You have active hepatitis B, hepatitis C, HIV, or cytomegalovirus (CMV) infection - You have uncontrolled high blood pressure or serious heart disease - You have another active cancer (beyond the myeloma being treated) - 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

DRUGCAR-T (CAR-GPRC5D)

CAR-GPRC5D (RD118) is an individualized, gene-modified autologous T-cell immunotherapy product targeting GPRC5D that identifies and eliminates malignant and normal cells expressing GPRC5D. The CAR structure comprises a fully human single-domain antibody fragment (VHH) targeting GPRC5D, fused with intracellular co-stimulatory (4-1BB) and activation (CD3ζ) signaling domains.


Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT05219721


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