Targeted 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.
Study summary
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Expected survival of at least 3 months;
2. Subjects should have measurable disease that meets the IMWG 2016 criteria;
3. Previously received at least two lines of prior anti-myeloma therapy ;
4. Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ;
5. BCMA positive;
6. ECOG score 0-1;
7. No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.
Exclusion Criteria:
1. Pregnant or breastfeeding women;
2. History of other malignant tumors;
3. Active autoimmune diseases requiring immunotherapy;
4. Previously received allogeneic stem cell transplantation;
5. Previous use of CAR-T cells or other genetically modified T cell therapies;
6. Previously received targeted BCMA therapy;
7. Severe cardiovascular disease;
8. Active infection;
9. Positive virology test;
10. Clinically significant central nervous system (CNS) diseases or pathological changes.
Primary outcome measure(s)
DLT — Within 28 Days After BRL-305 Infusion The number and severity of dose-limiting toxicity (DLT) events
AEs — Up to 24 Months After BRL-305 Infusion The total number, incidence, and severity of AEs
Trial sites (1)
Facility
City
Region
Status
Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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