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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07248176
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