Health TrialsbyHealthPanel

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

ConditionsMultiple MyelomaRefractory Multiple MyelomaRelapse Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Avigan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • DC/MM Fusion Vaccine

    Biological/Vaccine

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

  • GM-CSF

    Drug

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: DC/MM Fusion Vaccine:Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed 28 days post-vaccination.
2

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.

Time frame
Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
3

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.

Time frame
Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.
4

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.

Time frame
Assessed during the vaccination period of 8 weeks and then up to 1 year post-vaccination.

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months post-CAR-T cell therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Avigan

Lead sponsor

Beth Israel Deaconess Medical Center

Sponsor institution

The V Foundation

Collaborator

Source ClinicalTrials.gov
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