David Avigan
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the study drugs and vaccine involved in this study are: * DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) * Elranatamab (a type of T-cell engager antibody)
This is a phase 1 study to evaluate the feasibility, safety, clinical and immune effects of DC/MM fusion vaccine in combination with Elranatamab 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. This vaccine is individualized for each participant using dendritic cells (type of immune cells) from each participant. GM-CSF contains a substance that helps make more white blood cells. This medication is being used to possibly increase the effectiveness of t…
Inclusion Criteria for Tumor Collection: * Participants must have an established diagnosis of multiple myeloma * Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy * Participants must have at least 3 prior lines of therapy * Participants must be ≥18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Participants must have \> 20% plasma cells in the bone marrow core or aspirate differential \<30 days prior to enrollment. * ANC \> 1K/uL; Platelets \> 50 K/uL without transfu…
Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.
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