Multiple MyelomaPhase 1NCT07377435
DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM
A Phase 1 study testing DC/MM Fusion Vaccine and GM-CSF in people with Multiple Myeloma and Refractory Multiple Myeloma, run by David Avigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Refractory Multiple Myeloma, Relapse Multiple Myeloma
- What is being tested?
- DC/MM Fusion Vaccine and GM-CSF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 1 Mar 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
David Avigan, MD
About this study
Official title: 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)
Read the 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.
- Being tested
- DC/MM Fusion Vaccine, GM-CSF
- Keywords
- Multiple Myeloma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, MM
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC/MM Fusion VaccineBiological
Also called Dendritic Cell and Tumor Fusion Vaccine
Dendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol.
GM-CSFDrug
Also called Granulocyte-Macrophage Colony-Stimulating Factor
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| DC/MM Fusion Vaccine: | Experimental | 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 Receives: Biological: DC/MM Fusion Vaccine; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months post-CAR-T cell therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start30 Jan 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Avigan
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation
- Responsible party
- Sponsor-investigator, David Avigan, Beth Israel Deaconess Medical Center
- Investigators
- Jacalyn Rosenblatt, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377435
- Sponsor's protocol ID
- 25-799
- Status last verified
- May 2026
- First submitted
- 22 Jan 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Vaccination With DC/MM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07377435
- Acronym / sponsor ID
- 25-799
- Keywords
- Multiple Myeloma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, MM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- David AviganUniversity, hospital or other
- Collaborators
- The V Foundation
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC/MM Fusion Vaccine: | Experimental | Biological: DC/MM Fusion Vaccine, Drug: GM-CSF25 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (8 listed)
- Patients receiving other investigational drugs
- Patients with Plasma Cell Leukemia
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC/MM Fusion VaccineAlso: Dendritic Cell and Tumor Fusion VaccineDendritic Cell and tumor fusion vaccine, via subcutaneous injection (under the skin), per protocol. | Biological | DC/MM Fusion Vaccine: |
| GM-CSFAlso: Granulocyte-Macrophage Colony-Stimulating FactorGranulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care. | Drug | DC/MM Fusion Vaccine: |
Primary outcome
Treatment Limiting Toxicity (TLT) Rate
Time frame: Assessed 28 days post-vaccination.
TLT rate, defined as the proportion of participants who experience treatment-limiting toxicity (TLT) as detailed in Protocol Section 6.1.
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.
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.
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 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.
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.
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.
3 secondary outcomes
Complete Response (CR) Rate
Time frame: 12 months
Measurable Residual Disease (MRD) Negative Rate
Time frame: 12 months
Progression-Free Survival (PFS) at 12 months
Time frame: 12 months post-CAR-T cell therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacalyn Rosenblatt, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC/MM Fusion Vaccine and GM-CSF in people with Multiple Myeloma and Refractory Multiple Myeloma, run by David Avigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacalyn Rosenblatt, MD (617-667-9920, jrosenb1@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Limiting Toxicity (TLT) Rate (time frame: Assessed 28 days post-vaccination.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.