Safety and Efficacy of Anti-BCMA/GPRC5D CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma(rr/MM)

NCT05509530 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-22

No results posted yet for this study

Summary

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/GPRC5D infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Conditions

Interventions

OTHER

anti-BCMA/GPRC5D CAR-T CELL

anti-BCMA/GPRC5D autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy

Sponsors & Collaborators

  • Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Kailin Xu, M.D., Ph.D. · Xuzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2025-05-01
Completion
2025-05-01

Countries

  • China

Study Locations

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Entities

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 NCT05509530 on ClinicalTrials.gov