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Clinical Study on Evaluating the Safety and Effectiveness of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Have Received Third-line or Above Treatment

NCT07195617 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-26

No results posted yet for this study

Summary

This study is a single-arm, single-center clinical study, with the main purpose of IIT clinical trials to evaluate the safety and initial efficacy of BCMA-GPRC5DCAR-T cells in subjects with relapsed/refractory multiple myeloma (r/rMM). The dose of this study was set to 2.0×106/kg±50% CAR-T cells, and the infusion method was a single peripheral infusion.

After the screening period (W-8\~D-8), blood collection period (W-8\~D-8), pretreatment period (D-7\~D-3), and pre-infusion evaluation (D-2\~D-1), subjects were subjected to infusion of CAR-T cells in D0. After administration, they were subjected to safety, effectiveness and other related examinations according to the follow-up plan. The subjects followed up until 2 years after cell re-infusion or the subject met the withdrawal treatment standards, whichever occurs first.

Conditions

Interventions

DRUG

BCMA-GPRC5D CART

The entire study process was as follows: Screening period (V1) : Informed consent was signed, screening was checked, criteria were evaluated, and baseline demographic information and subject status were recorded. Blood collection period (V2) : For subjects who meet the inclusion and exclusion criteria, the blood required for CAR-T preparation will be obtained by leukocyte isolation monopexy or intravenous collection according to the conditions of the subjects. Preconditioning phase (V3) : cytokine and cell changes. Pre-transfusion assessment (V4) : The investigator assessed that the test results met the cell transfusion criteria, and D0 CAR T cell infusion could be performed with investigator permission. Infusion phase (V5) : CAR-T cells were transfused according to the dosage and method specified in the protocol. Safety and efficacy were followed up on D1, D4, D7, D10, D14, D21, D28, M3, M6, M9, M12, and M24.

Sponsors & Collaborators

  • Jiangsu Provincial People's Hospital

    collaborator OTHER

  • Guangzhou Bio-gene Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2027-11-01
Completion
2027-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195617 on ClinicalTrials.gov