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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
David Avigan
Study ID
NCT07377435
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DC/MM Fusion Vaccine — BIOLOGICAL
    Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.
  • GM-CSF — DRUG
    Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.

Study Details

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)

Key Dates

Start date
Jan 30, 2026
Status verified
May 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DC/MM Fusion Vaccine:
    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

Primary Outcome Measure

Treatment Limiting Toxicity (TLT) Rate [ Time Frame: Assessed 28 days post-vaccination. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
David Avigan, MD
[email protected]
617-667-9920
David Avigan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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