RecruitingPhase 1NCT05759793

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

Nanjing IASO Biotechnology Co., Ltd.

Enrollment

12 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, open-label, dose-escalation 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 trial is studying a new CAR-T cell therapy targeting a protein called GPRC5D, which is found on the surface of multiple myeloma cells. CAR-T therapy uses the patient's own immune cells, modified in a lab to seek and destroy cancer cells. This is for people whose myeloma has come back or stopped responding to multiple prior treatments. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with multiple myeloma or plasma cell leukemia that has returned or no longer responds to treatment - You have already tried at least 3 prior treatment regimens, including drugs from at least two major myeloma drug classes **You may NOT be eligible if...** - You have active serious infections or uncontrolled disease in another organ - You have previously received anti-GPRC5D treatment - You have significant heart, lung, liver, or kidney problems - 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-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)

Ruijin Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT05759793


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