An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in Patients With Relapsed / Refractory(r/r) Multiple Myeloma(MM) Who Have Received Third-line or More Treatments

NCT05749133 Phase 1/Phase 2 UNKNOWN

It is a single-center, open-labeled, single-arm, non-randomized investigatorinitiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM) after three or more lines of treatments.

Details

Lead sponsor	XuYan
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	18
Start date	2023-04-10
Completion	2025-12

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

• Anti-GPRC5D CAR-T Cells Injection

Primary outcomes

• Incidence of adverse events(AE) after infusion — Up to the subject withdrew or 24 months after CAR-T infusion.
  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.
• Dose limited toxicity (DLT) — Up to 28 days after infusion.
  Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion.
• Overall response rate(ORR) — Day 28 and months 3, 6, 9, 12, 18, 24 after CAR-T infusion.
  Overall Response Rate (ORR) is defined as the proportion of subjects achieving strict complete remission(sCR), complete response(CR), very good partial response(VGPR) and partial response(PR).
• Clinical benefit rate — Day 28 and months 3, 6, 9, 12, 18, 24 after CAR-T infusion.
  It's defined as the sum of the proportion of subjects who achieved ORR (sCR + CR + VGPR + PR) and minimal response (MR) according to the International Myeloma Working Group (IMWG) criteria.
• Progression-free survival(PFS) — Up to 24 months after CAR-T infusion.
  Progression-free survival(PFS) refers to the time from cell reinfusion to the first assessment of tumor progression or death from any cause.
• Overall survival(OS) — Up to 24 months after CAR-T infusion.
  Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-T cells until death (from any cause).

Countries

China