Phase I Trial of DCMM Fusion Vaccine Combined With BCMA CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a dendritic cell DCMM fusion vaccine combined with the standard BCMA CAR-T cell therapy for people with relapsed or refractory multiple myeloma. This Phase I study explores how the fusion vaccine may help the immune system recognize and fight cancer cells. The study is funded by the V Foundation for Cancer Research and involves about 25 participants. Participants will undergo a baseline visit and leukapheresis to collect dendritic and tumor cells. They will then receive standard BCMA CAR-T cell therapy followed by two 28-day cycles of daily DCMM fusion vaccine and GM-CSF injections under the skin. After the vaccination period, follow-up visits will occur every three months from month 12 up to five years. Throughout the study, participants will have blood and urine tests, imaging scans CT, MRI, PET, X-rays, ECGs, and bone marrow biopsies to monitor health and response. Researchers will track vaccine-related side effects, immune responses, and disease progression. Safety and treatment-limiting toxicities will be assessed up to one year after vaccination. Total participation may last several years due to extended follow-up.

DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM