NCT06799026

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: David Avigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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 the DC/MM fusion vaccine. 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 not approved GM-CSF as a treatment for Relapsed or Refractory Multiple Myeloma. The FDA has approved elranatamab as a treatment option for Relapsed or Refractory Multiple Myeloma. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, study drug subcutaneous (under the skin) injections, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and bone marrow biopsies and aspirations (or collections). Participants will receive study treatment for up to 12 cycles (28-day cycles) and will be followed for up to 5 years. It is expected that about 25 people will take part in this research study. Pfizer is funding this research study by providing one of the study drugs, Elranatamab.

Conditions

• Multiple Myeloma
• Relapse Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elranatamab	Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
BIOLOGICAL	GM-CSF	Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
BIOLOGICAL	DC/MM Fusion Vaccine	Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.

Timeline

• Start date: 2025-01-31
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2025-01-29
• Last updated: 2025-09-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study