Status:
NOT_YET_RECRUITING
Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT
Lead Sponsor:
Xuzhou Medical University
Conditions:
Multiple Myeloma, Newly Diagnosed
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of new...
Detailed Description
1. Pre-screening Evaluation. The patient's medical history will be reviewed to assess eligibility based on inclusion criteria. The treatment process and potential risks will be explained, and informed...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years (inclusive);
- Estimated life expectancy of more than 12 weeks;
- Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
- Karnofsky Performance Status (KPS) score \> 50%.
- Eligible for ASCT.
Exclusion
- Pregnant or lactating women, or women planning to become pregnant within the next six months;
- Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
- History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
- Significant dysfunction of vital organs including the heart, lungs, or brain;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06963866
Start Date
May 1 2025
End Date
April 30 2028
Last Update
May 9 2025
Active Locations (1)
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1
The Affiliated Hospital oh Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006