Phase I Study of Vaccination With DC/MM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma
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.
Arms & 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.
Outcome measures
Primary
Treatment Limiting Toxicity (TLT) Rate
TLT rate, defined as the proportion of participants who experience treatment-limiting toxicity (TLT) as detailed in Protocol Section 6.1.
Time frame: Assessed 28 days post-vaccination.
Vaccine/Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF)-Related Adverse Event (AE) Rate
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.
Time frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
Grade 3 or 4 Cytokine Release Syndrome (CRS) Rate
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.
Time frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
Grade 3 or 4 Immune-effector Cell-associated Neurotoxicity (ICANS) Rate
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.
Time frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
Secondary
Complete Response (CR) Rate
Time frame: 12 months
Measurable Residual Disease (MRD) Negative Rate
Time frame: 12 months
Progression-Free Survival (PFS) at 12 months
Time frame: 12 months post-CAR-T cell therapy
Eligibility criteria
Study locations (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215