RecruitingNot ApplicableNCT07248176

Universal CAR-T Cell Therapy for MM

A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma


Sponsor

Bioray Laboratories

Enrollment

6 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Expected survival of at least 3 months;
  • Subjects should have measurable disease that meets the IMWG 2016 criteria;
  • Previously received at least two lines of prior anti-myeloma therapy ;
  • Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ;
  • BCMA positive;
  • ECOG score 0-1;
  • No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.

Exclusion Criteria10

  • Pregnant or breastfeeding women;
  • History of other malignant tumors;
  • Active autoimmune diseases requiring immunotherapy;
  • Previously received allogeneic stem cell transplantation;
  • Previous use of CAR-T cells or other genetically modified T cell therapies;
  • Previously received targeted BCMA therapy;
  • Severe cardiovascular disease;
  • Active infection;
  • Positive virology test;
  • Clinically significant central nervous system (CNS) diseases or pathological changes.

Interventions

DRUGTargeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection

The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.


Locations(1)

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, China

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NCT07248176


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