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Recruiting

NCT Number: NCT07248176

Universal CAR-T Cell Therapy for MM

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, 620000, China

Location status: Recruiting

Location contact

Ping Li, phD

CONTACT

13564181131

About this study

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Drug

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

Other names: BRL-305

Primary outcomes

  1. DLT

    Time frame: Within 28 Days After BRL-305 Infusion

    The number and severity of dose-limiting toxicity (DLT) events

  2. AEs

    Time frame: Up to 24 Months After BRL-305 Infusion

    The total number, incidence, and severity of AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Li, phD

CONTACT

[email protected]

13564181131

Sponsors and collaborators

Lead sponsor

Bioray Laboratories

Industry

Collaborators

  • Shanghai Tongji Hospital, Tongji University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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