RecruitingPhase 1NCT07377435

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

Phase I Study of Vaccination With DC/MM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

Sponsor

David Avigan

Enrollment

25 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Refractory Multiple Myeloma Relapse Multiple Myeloma

Summary

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

Min Age: 18 Years

Inclusion Criteria23

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.
Patients must have adequate organ function as defined below:
Total bilirubin ≤ 1.5 x institutional upper limit of normal
AST ≤ 3 x institutional upper limit of normal
ALT ≤ 3 x institutional upper limit of normal
Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
The effects of DC/MM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.
Ability to understand and willingness to sign a written informed consent document.
Resolution of all CAR T- related grade 3-4 toxicities
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
ECOG performance status ≤ 2
Patients must have adequate organ function as defined below:
Total bilirubin ≤ 1.5 x institutional upper limit of normal
AST ≤ 3 x institutional upper limit of normal
ALT ≤ 3 x institutional upper limit of normal
Creatinine within normal limits or Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
ANC >1000 in the absence of growth factor support in the prior 7 days
Platelet count >50K without the need for transfusion in the prior 7 days
No myeloma-directed therapy following administration of CAR T-cells

Exclusion Criteria8

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.
Female patients who are pregnant (positive β-HCG) or breastfeeding.
Prior organ transplant requiring immunosuppressive therapy.
Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
History of intolerance to CAR-T related drugs or GM-CSF.