Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed/refractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy.
Therefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.
Age: 18-70 years old
Expected survival: >12 weeks
Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies
Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors
Pregnancy or lactation, or women planning pregnancy within the next 6 months
Infectious diseases(e.g., HIV, active tuberculosis)
Active hepatitis B or C infection
Feasibility assessment showing lymphocyte-targeted transfection rate <10% or insufficient expansion (<5-fold) under CD3/CD28 co-stimulation
Single group
autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy
Other interventionThe efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \[CR\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors.
Progression-Free Survival(PFS):Time between treatment and disease progression or death
The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \[CR\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors.
MRD
Refers to residual tumor cells or small lesions that still exist in the patient's body after treatment but cannot be detected by imaging methods
OS
The time from the time the patient receives treatment to the patient's death due to any cause
To assess the safety of transplantation in combination with CAR-T
1. Detection of CRS-related factors: such as IFN, IL-6, TNF, IL-10, IL-4, CRP, etc 2. Various laboratory tests: blood routine, coagulation function, blood film observation, liver function, kidney function, electrolytes, blood glucose, cardiac enzymes, T cell subsets, immunoglobulins, etc 3. Observation of adverse events and serious adverse events.
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The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Shuyang People's Hospital
Collaborator
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