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

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)

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Refractory Multiple Myeloma; Relapse Multiple Myeloma
• Intervention / Treatment: Biological: DC/MM Fusion Vaccine; Drug: GM-CSF

Detailed Description

This Phase I 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 DC/MM fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells.

The U.S. Food and Drug Administration (FDA) has not approved DC/MM fusion vaccine as a treatment for relapsed or refractory multiple myeloma.

The FDA has approved GM-CSF as a treatment for relapsed or refractory multiple myeloma.

The research study procedures include screening for eligibility, in-clinic visits, collection of dendritic and tumor cells in a process called leukapheresis, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, X-rays, electrocardiograms (ECGs), bone marrow biopsies and aspirations.

It is expected about 25 people will take part in this research study.

The V Foundation for Cancer Research is providing funding for this study.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jacalyn Rosenblatt, MD; Phone Number: 617-667-9920; Email: jrosenb1@bidmc.harvard.edu
• Study Contact Backup: Name: Emma Logan, MSN; Phone Number: 617-667-9920; Email: eklogan@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: David Avigan, MD; Phone Number: 617-667-9920; Email: davigan@bidmc.harvard.edu
      • Principal Investigator: David Avigan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Biological: DC/MM Fusion Vaccine; Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.; Other Names: Dendritic Cell and Tumor Fusion Vaccine; Drug: GM-CSF; Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.; Other Names: Granulocyte-Macrophage Colony-Stimulating Factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Limiting Toxicity (TLT) Rate	TLT rate, defined as the proportion of participants who experience treatment-limiting toxicity (TLT) as detailed in Protocol Section 6.1.	Assessed 28 days post-vaccination.
Vaccine/Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF)-Related Adverse Event (AE) Rate	Vaccine/GM-CSF-related AE rate is defined as the proportion of participants who experience any grade AE deemed by investigators as possibly, probably, or definitely related to vaccine or GM-CSF based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.	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	Grade 3 or 4 CRS rate is defined as the proportion of participants who experience grade 3 or 4 CRS based on the American Society of Transplantation and Cellular Therapy (ASTCT) consensus guidelines.	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	Grade 3 or 4 ICANS rate is defined as the proportion of participants who experience grade 3 or 4 ICANS based on the American Society of Transplantation and Cellular Therapy (ASTCT) consensus guidelines.	Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate	CR rate is defined as the proportion of participants who experience CR or stringent CR per International Myeloma Working Group (IMWG) Uniform Response Criteria.	12 months
Measurable Residual Disease (MRD) Negative Rate	Measurable Residual Disease (MRD) Negative Rate is defined as the proportion of patients who achieve MRD negativity, as assessed by clonoSEQ. Participants who receive at least 1 dose of the vaccine will be included in the analysis.	12 months
Progression-Free Survival (PFS) at 12 months	PFS based on Kaplan-Meier method is defined as the time from registration to the earlier of progression per International Myeloma Working Group (IMWG) Uniform Response Criteria or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.	12 months post-CAR-T cell therapy

Collaborators and Investigators

• Sponsor: David Avigan
• Collaborators: The V Foundation
• Investigators: Principal Investigator: Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; MM; Refractory Multiple Myeloma; Relapsed Multiple Myeloma
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Carbohydrates; Intercellular Signaling Peptides and Proteins; Glycoproteins; Glycoconjugates; Colony-Stimulating Factors; Hematopoietic Cell Growth Factors; Cytokines; Granulocyte-Macrophage Colony-Stimulating Factor
• Other Study ID Numbers: 25-799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No