Phase I Study of Vaccination With DC/MM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma
David Avigan
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)
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 m…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma * Patients must be ≥18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment. * Patients must have adequate organ function as defined below: * Total bilirubin ≤ 1.5 x institutional upper limit of normal * AST ≤ 3 x institutional upper limit of normal * ALT ≤ 3 x institutional upper limit of norma…
Interventions
- BiologicalDC/MM Fusion Vaccine
Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.
- DrugGM-CSF
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts