drugset / Trial / NCT07195617

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 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped (Business): “Due to corporate strategic adjustment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject BCMA-GPRC5D CART Cell therapy 2e+06 cells/kg Intravenous