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

NCT07377435 Phase 1 RECRUITING

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)

Details

Lead sponsor	David Avigan
Phase	Phase 1
Status	RECRUITING
Enrolment	25
Start date	2026-01-30
Completion	2032-03-01

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Relapse Multiple Myeloma

Interventions

• DC/MM Fusion Vaccine
• GM-CSF

Primary outcomes

• Treatment Limiting Toxicity (TLT) Rate — Assessed 28 days post-vaccination.
  TLT rate, defined as the proportion of participants who experience treatment-limiting toxicity (TLT) as detailed in Protocol Section 6.1.
• Vaccine/Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF)-Related Adverse Event (AE) Rate — Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
  Vaccine/GM-CSF-related AE rate is defined as the proportion of participants who experience any grade AE deemed by investigators as possibly, probably, or definitely related to vaccine or GM-CSF based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
• Grade 3 or 4 Cytokine Release Syndrome (CRS) Rate — Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
  Grade 3 or 4 CRS rate is defined as the proportion of participants who experience grade 3 or 4 CRS based on the American Society of Transplantation and Cellular Therapy (ASTCT) consensus guidelines.
• Grade 3 or 4 Immune-effector Cell-associated Neurotoxicity (ICANS) Rate — Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
  Grade 3 or 4 ICANS rate is defined as the proportion of participants who experience grade 3 or 4 ICANS based on the American Society of Transplantation and Cellular Therapy (ASTCT) consensus guidelines.

Countries

United States