car-t cell therapy combined with allogeneic hematopoietic stem cell transplantation for relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

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 and efficacy of car-t cell therapy followed by allogeneic hematopoietic stem cell transplantation (allo-hsct) in patients with relapsed or refractory multiple myeloma. the goal is to explore a novel treatment strategy for this high-risk patient population. 3. study design this is a single-center, open-label, single-arm clinical study. a total of 30 patients with relapsed or refractory multiple myeloma will be enrolled. all participants will receive standardized car-t cell therapy followed by allo-hsct and will undergo systematic observation and follow-up to assess therapeutic efficacy and safety. 4. sample size a total of 30 patients will be enrolled in this study. 5. eligibility criteria (1) inclusion criteria 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 \ 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. (2) exclusion criteria 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. 6. treatment protocol all enrolled patients will first receive car-t cell therapy. patients who achieve complete remission (cr) following car-t infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-hsct) based on clinical assessment. the entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.


Eligibility criteria:
inclusion criteria: 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 \ 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 criteria: 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.