Actively Recruiting
Phase I Study of DC/MM Fusion Vaccine Combined With BCMA CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma
Led by David Avigan · Updated on 2026-05-08
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
D
David Avigan
Lead Sponsor
T
The V Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a dendritic cell DC/MM fusion vaccine combined with the standard BCMA CAR-T cell therapy for people with relapsed or refractory multiple myeloma. This Phase I study explores how the fusion vaccine may help the immune system recognize and fight cancer cells. The study is funded by the V Foundation for Cancer Research and involves about 25 participants. Participants will undergo a baseline visit and leukapheresis to collect dendritic and tumor cells. They will then receive standard BCMA CAR-T cell therapy followed by two 28-day cycles of daily DC/MM fusion vaccine and GM-CSF injections under the skin. After the vaccination period, follow-up visits will occur every three months from month 12 up to five years. Throughout the study, participants will have blood and urine tests, imaging scans (CT, MRI, PET, X-rays), ECGs, and bone marrow biopsies to monitor health and response. Researchers will track vaccine-related side effects, immune responses, and disease progression. Safety and treatment-limiting toxicities will be assessed up to one year after vaccination. Total participation may last several years due to extended follow-up.
CONDITIONS
Brief Title
DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for standard BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma
- Age 18 years or older
- ECOG performance status of 2 or less
- At least 20% plasma cells in bone marrow within 30 days prior to enrollment
- Adequate organ function (bilirubin ≤1.5x normal, AST and ALT ≤3x normal, creatinine clearance ≥40 mL/min if creatinine elevated)
- Agreement to use contraception if of child-bearing potential during and 6 months after study
- Ability to understand and sign informed consent
- Resolution of all CAR T-related grade 3-4 toxicities before vaccination
- Successful production of at least 2 vaccines with minimum fusion cells
- No disease progression following CAR T-cell therapy
- ANC >1000 without growth factor support in prior 7 days
- Platelet count >50,000 without transfusion in prior 7 days
- No myeloma-directed therapy after CAR T-cells before vaccination
You will not qualify if you...
- Receiving other investigational drugs
- Diagnosis of Plasma Cell Leukemia
- Active uncontrolled infections including HIV, hepatitis B, or hepatitis C
- Recent myocardial infarction (within 6 months) or severe heart conditions
- Pregnant or breastfeeding women
- Prior organ transplant requiring immunosuppressive therapy
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, or psychiatric illness limiting compliance
- History of intolerance to CAR-T related drugs or GM-CSF
- ECG abnormalities deemed medically relevant at screening
- Myeloma-directed therapy after CAR T-cell therapy prior to vaccination if criteria unmet
- Inability to produce required vaccine cells or unresolved severe toxicities prior to vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two 28-day cycles
Participants receive standard of care BCMA CAR-T cell therapy combined with DC/MM fusion vaccine and GM-CSF injections over two 28-day cycles.
Daily vaccine and GM-CSF injections during cycles; leukapheresis and baseline visit prior to treatment
Duration - Approximately 4 years
Participants are followed up every 3 months from month 12 to year 5 to monitor safety and effectiveness.
Quarterly visits starting at month 12 through year 5
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jacalyn Rosenblatt, MD
E
Emma Logan, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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