RecruitingPhase 1NCT06799026

A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma


Sponsor

David Avigan

Enrollment

25 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a combination of two treatments: a personalized cancer vaccine (made from fusing a patient's own immune cells called dendritic cells with their myeloma cells) and a drug called elranatamab, for people with multiple myeloma (a blood cancer) that has relapsed or stopped responding to prior therapies. **You may be eligible if...** - You are 18 or older and have a confirmed diagnosis of multiple myeloma - Your cancer has relapsed or stopped responding to treatment, including prior treatment with proteasome inhibitors, immunomodulatory drugs (IMiDs), and an anti-CD38 antibody - You have received at least 3 prior lines of therapy - You have more than 20% plasma cells (myeloma cells) in your bone marrow - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You have received fewer than 3 prior lines of therapy - You have poor organ function or very low blood counts - You have active serious infections or other conditions making treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElranatamab

Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.

BIOLOGICALGM-CSF

Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.

BIOLOGICALDC/MM Fusion Vaccine

Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.


Locations(2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06799026


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