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
1 other identifier
interventional
25
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Jan 2026
Longer than P75 for phase_1 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2032
May 8, 2026
May 1, 2026
2.1 years
January 22, 2026
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Complete Response (CR) Rate
12 months
Measurable Residual Disease (MRD) Negative Rate
12 months
Progression-Free Survival (PFS) at 12 months
12 months post-CAR-T cell therapy
Study Arms (1)
DC/MM Fusion Vaccine:
EXPERIMENTAL25 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
Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Aviganlead
- The V Foundationcollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacalyn Rosenblatt, MD
Beth Israel Deaconess Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
January 22, 2026
First Posted
January 29, 2026
Study Start
January 30, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2032
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
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.