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Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

NCT05749133 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Interventions

BIOLOGICAL

Anti-GPRC5D CAR-T Cells Injection

This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells: Initial dose group: 3.0×10\^6/kg±20%; Low dose group: 3.0×10\^6/kg±20%; High dose group: 6.0×10\^6/kg±20%. Dose was weight-based.

Sponsors & Collaborators

  • XuYan

    lead OTHER

Principal Investigators

  • Yan Xu, MD · Institute of Hematology & Blood Diseases Hospital, China

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
2023-04-10
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT05749133 on ClinicalTrials.gov