Recruiting
Phase 1

DC/MM Fusion Vaccine & BCMA CAR-T

Sponsor:

David Avigan

Code:

NCT07377435

Conditions

Multiple Myeloma

Refractory Multiple Myeloma

Relapse Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DC/MM Fusion Vaccine

GM-CSF

Study Details

Brief 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)

Conditions

Multiple Myeloma

Refractory Multiple Myeloma

Relapse Multiple Myeloma

Study ID

NCT07377435

Start date

Jan 30, 2026

Status verified date

May, 2026

Completion date

Mar 1, 2032

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Inclusion Criteria Prior to Vaccination with DC/MM Fusions:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

DC/MM Fusion Vaccine

Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.

GM-CSF

Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.

Primary outcome measure

  • Treatment Limiting Toxicity (TLT) Rate [ Time Frame: Assessed 28 days post-vaccination. ]
  • Vaccine/Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF)-Related Adverse Event (AE) Rate [ Time Frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination. ]
  • Grade 3 or 4 Cytokine Release Syndrome (CRS) Rate [ Time Frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination. ]
  • Grade 3 or 4 Immune-effector Cell-associated Neurotoxicity (ICANS) Rate [ Time Frame: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination. ]

Central Contacts and Locations

Central contacts

Jacalyn Rosenblatt, MD

617-667-9920jrosenb1@bidmc.harvard.edu

Emma Logan, MSN

617-667-9920eklogan@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

David Avigan, MD

617-667-9920davigan@bidmc.harvard.edu

Principal Investigator:

David Avigan, MD

More Information

Sponsor

David Avigan

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Multiple Myeloma
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma
  • MM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Avigan on 2026-05-08.