Actively Recruiting
DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
Led by David Avigan · Updated on 2026-05-08
25
Participants Needed
1
Research Sites
317 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
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)
CONDITIONS
Official Title
DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma
- Patients must be 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment
- Patients must have adequate organ function: total bilirubin 1.5 times or less the institutional upper limit of normal, AST 3 times or less the institutional upper limit of normal, ALT 3 times or less the institutional upper limit of normal, creatinine clearance 40 mL/min or more if creatinine is above institutional normal
- Women and men of child-bearing potential must agree to use adequate contraception prior to and during study participation; men must continue contraception for 6 months after treatment
- Ability to understand and willingness to sign a written informed consent document
- Resolution of all CAR T-related grade 3-4 toxicities prior to vaccination
- Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells
- Absence of disease progression following CAR T-cell therapy
- Absolute neutrophil count greater than 1000 without growth factor support in the prior 7 days
- Platelet count greater than 50,000 without the need for transfusion in the prior 7 days
- No myeloma-directed therapy following administration of CAR T-cells
You will not qualify if you...
- Patients receiving other investigational drugs
- Patients with Plasma Cell Leukemia
- Patients with known active uncontrolled infections including HIV, hepatitis C, or hepatitis B
- History of myocardial infarction within 6 months prior to enrollment or severe heart failure (NYHA Class III or IV), uncontrolled angina, or severe uncontrolled ventricular arrhythmias
- Pregnant or breastfeeding female patients
- Prior organ transplant requiring immunosuppressive therapy
- Uncontrolled illness including active infection, symptomatic congestive heart failure, unstable angina, or psychiatric/social conditions limiting study compliance
- History of intolerance to CAR-T related drugs or GM-CSF
AI-Screening
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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
CONTACT
E
Emma Logan, MSN
CONTACT
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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