Status:
NOT_YET_RECRUITING
CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Xuzhou Medical University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
1. Study Title CAR-T Cell Therapy Combined with Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma 2. Study Objective This study aims to evaluate the safety...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \< 3 times the upper limit of normal; Total bilirubin \< 2.0 mg/dL; Karnofsky Performance Status (KPS) \> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.
Exclusion
- Pregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); 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; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06913179
Start Date
April 1 2025
End Date
March 31 2028
Last Update
April 6 2025
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