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

Overseen By Emma Logan, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: David Avigan

Must not be taking: Investigational drugs

Disqualifiers: Plasma cell leukemia, HIV, HCV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

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.

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?

Group I: DC/MM Fusion Vaccine: Experimental Treatment 2 Interventions

25 participants will be enrolled and will complete the following: * Baseline visit * Leukapheresis for dendritic and tumor cell collection * Standard of care BCMA CAR-T cell therapy * Cycles 1 through 2 (28 day cycle): --Day 1: predetermined dose of DC/MM Fusion Vaccine 1x daily and predetermined dose of GM-CSF 1x daily * Follow up every 3 months starting at month 12 to year 5

Who Is Running the Clinical Trial?

David Avigan

Lead Sponsor

Trials

1

Recruited

30+

The V Foundation

Collaborator

Trials

10

Recruited

320+