Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma

Condition(s) studied

Investigational drug(s) / intervention(s)

autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival(PFS):Time between treatment and disease progression or death — Pre-hematopoietic stem cell transplant evaluation、assessed at two weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after CAR-T infusion
  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 — Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion
  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 — Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion
  The time from the time the patient receives treatment to the patient's death due to any cause

Trial sites (1)

More The Affiliated Hospital of Xuzhou Medical University trials in China

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