DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Avigan
About 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)
Eligibility criteria
Qualifiers
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
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment.
Disqualifiers
Patients receiving other investigational drugs
Patients with Plasma Cell Leukemia
Patients who have known active uncontrolled infections with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
Trial design
Treatments tested in this trial
- DC/MM Fusion Vaccine
- GM-CSF
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
David Avigan
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
The V Foundation
Collaborator
Source ClinicalTrials.gov