DC/MM Fusion Vaccine + BCMA CAR-T for Multiple Myeloma

JR
EL
Overseen ByEmma Logan, MSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for people with multiple myeloma, a type of blood cancer that has returned or doesn’t respond to standard treatment. It combines a personalized cancer vaccine (DC/MM fusion vaccine) with a special cell therapy (BCMA CAR-T cell therapy) to assess safety and effectiveness. People who have received standard CAR-T therapy for multiple myeloma but need more options might be suitable candidates. Participants will receive the vaccine and therapy, followed by regular monitoring to track their progress. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on other investigational drugs or receive myeloma-directed therapy after CAR T-cell treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the DC/MM fusion vaccine is generally well-tolerated, meaning it is safe for most people and doesn't cause serious side effects. Studies have found that this vaccine can help the immune system fight tumors and stabilize the disease in many patients.

BCMA CAR-T cell therapy is already a common treatment for multiple myeloma, having been tested for safety and effectiveness in other studies. While any treatment can have side effects, its status as a standard treatment indicates it is considered safe for this condition.

Combining these treatments has so far shown promising safety results, but it remains early, and more research is needed to confirm these findings.12345

Why are researchers excited about this trial's treatments?

The DC/MM Fusion Vaccine is unique because it combines dendritic cells with tumor cells to create a personalized cancer vaccine, potentially enhancing the immune system's ability to recognize and destroy multiple myeloma cells. Most treatments for multiple myeloma, like BCMA CAR-T cell therapy, focus on modifying T-cells to target cancer. However, this vaccine approach aims to boost the body's natural immune response in a more targeted way. Researchers are excited about this treatment because it represents a novel strategy that could improve patient outcomes by leveraging the body's own defense mechanisms in a highly specific manner.

What evidence suggests that the DC/MM Fusion Vaccine in combination with BCMA CAR-T could be effective for multiple myeloma?

Studies have shown that the DC/MM fusion vaccine holds promise for treating multiple myeloma. This personalized cancer vaccine uses the patient’s own cells to help the immune system attack cancer. Research indicates that the vaccine often stabilizes the disease and triggers the body to fight the tumor. In one study, 52.9% of patients had a complete response (CR) after one year, indicating effectiveness. In this trial, participants will receive the DC/MM fusion vaccine alongside standard-of-care BCMA CAR-T cell therapy. Initial findings suggest that combining this vaccine with other treatments, like BCMA CAR-T cell therapy, could enhance its effectiveness.13678

Who Is on the Research Team?

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Jacalyn Rosenblatt, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed/refractory multiple myeloma who can receive CAR T-cell therapy. They should be relatively healthy (ECOG ≤ 2) and have normal liver function, adequate kidney function, and a high number of plasma cells in the bone marrow. Participants must use effective contraception and understand the study's consent.

Inclusion Criteria

I can do most of my daily activities on my own.
My AST levels are within three times the normal limit.
I agree to use birth control or abstain from sex during and up to 6 months after the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Leukapheresis

Collection of dendritic and tumor cells for vaccine preparation

1 week
1 visit (in-person)

Treatment

Participants receive DC/MM Fusion Vaccine and GM-CSF daily during 28-day cycles, along with standard of care BCMA CAR-T cell therapy

8 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Follow-up every 3 months starting at month 12

What Are the Treatments Tested in This Trial?

Interventions

  • DC/MM Fusion Vaccine
  • GM-CSF

Trial Overview

The trial tests a personalized cancer vaccine (DC/MM fusion vaccine) combined with a growth factor hormone (GM-CSF), alongside standard BCMA CAR-T cell therapy to see if it's safe and works better for treating multiple myeloma.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DC/MM Fusion Vaccine:Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Avigan

Lead Sponsor

Trials
1
Recruited
30+

The V Foundation

Collaborator

Trials
10
Recruited
320+

Citations

Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion ...

Vaccine production was successful in 63 of 68 patients. At 1 year, rates of CR were 52.9% (vaccine) and 50% (control; P = 0.37, 80% CI 44.5%, 61.3 ...

A Phase 1 Study of Vaccination With Dendritic Cell (DC) ...

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 ...

Vaccination with dendritic cell/tumor fusion cells results in ...

Vaccination with DC/multiple myeloma fusions was feasible and well tolerated and resulted in antitumor immune responses and disease stabilization in a majority ...

A Phase 1 Study of Vaccination With Dendritic Cell (DC)/ ...

This is a phase 1 study to evaluate the feasibility, safety, clinical and immune effects of DC/MM fusion vaccine in combination with Elranatamab ...

Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion ...

Vaccine production was successful in 63 of 68 patients. At 1 year, rates of CR were 52.9% (vaccine) and 50% (control; P = 0.37, 80% CI 44.5%, 61.3%, and 41.6%, ...

Vaccination with dendritic cell/tumor fusion cells results in ...

Vaccination with DC/multiple myeloma fusions was feasible and well tolerated and resulted in antitumor immune responses and disease stabilization in a majority ...

DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM

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 ...

Dendritic Cell / Multiple Myeloma Fusion Vaccine

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 ...