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Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

NCT06196255 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-09

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-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Conditions

Interventions

DRUG

anti-FcRL5 CAR-T

anti-FcRL5 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, MD.,PD. · The Affiliated Hospital oh 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
2023-12-25
Primary Completion
2027-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06196255 on ClinicalTrials.gov