Status:
NOT_YET_RECRUITING
Efficacy of Sequential BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Xuzhou Medical University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
1. Study Title A Single-Center, Open-Label, Single-Arm Clinical Study of Sequential Anti-BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-Eligible New...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years; Estimated life expectancy \> 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, histopathology, laboratory tests, and imaging; Liver function: ALT and AST \< 3 times the upper limit of normal; Karnofsky Performance Status (KPS) score \> 50%; No severe dysfunction of major organs such as the liver or heart; Willingness to undergo ASCT and CAR-T cell therapy for multiple myeloma; Ability to provide peripheral venous blood and no contraindications to leukapheresis; Ability to understand the study and sign a written informed consent voluntarily.
Exclusion
- Pregnant or lactating women, or those planning pregnancy within six months; Patients with infectious diseases, including HIV infection or active tuberculosis; Patients with active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T cell transduction efficiency \<10% or expansion fold \<5× under CD3/CD28 co-stimulation; Patients with abnormal vital signs or unable to cooperate with the procedures; Patients with psychiatric or psychological disorders that impair compliance or assessment; Patients with a history of severe allergies or hypersensitivity, particularly to interleukin-2 (IL-2); Patients with systemic or severe local infections requiring anti-infective therapy; Patients with significant dysfunction of vital organs such as the heart, lungs, or brain; Any other condition deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06913192
Start Date
April 1 2025
End Date
February 28 2028
Last Update
April 6 2025
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