NCT07377435

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

Phase I Study of Vaccination With DC/MM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: David Avigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and effectiveness of dendritic cell DC/MM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed/refractory multiple myeloma. The names of the study drugs involved in this study are: * DC/MM fusion vaccine (a type of personalized cancer vaccine) * Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)

Detailed description

This Phase I study is to evaluate the safety and effectiveness of dendritic cell DC/MM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed/refractory multiple myeloma. The DC/MM fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. The U.S. Food and Drug Administration (FDA) has not approved DC/MM fusion vaccine as a treatment for relapsed or refractory multiple myeloma. The FDA has approved GM-CSF as a treatment for relapsed or refractory multiple myeloma. The research study procedures include screening for eligibility, in-clinic visits, collection of dendritic and tumor cells in a process called leukapheresis, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, X-rays, electrocardiograms (ECGs), bone marrow biopsies and aspirations. It is expected about 25 people will take part in this research study. The V Foundation for Cancer Research is providing funding for this study.

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Relapse Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	DC/MM Fusion Vaccine	Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.
DRUG	GM-CSF	Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-03-01
• Completion: 2032-03-01
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study