A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the study drugs and vaccine involved in this study are: * DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) * Elranatamab (a type of T-cell engager antibody)
Sponsor: David Avigan
You may qualify if…
- ✓ Participants must have an established diagnosis of multiple myeloma
- ✓ Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy
- ✓ Participants must have at least 3 prior lines of therapy
- ✓ Participants must be ≥18 years of age
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- ✓ Participants must have \> 20% plasma cells in the bone marrow core or aspirate differential \<30 days prior to enrollment.
- ✓ ANC \> 1K/uL; Platelets \> 50 K/uL without transfusional support
- ✓ Participants must have adequate organ function as defined below:
You may not qualify if…
- ✕ Patients who are receiving any other investigational agents.
- ✕ Patients with purely non-secretory MM \[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \>100 mg/L\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- ✕ Patients with Plasma Cell Leukemia
- ✕ Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
- ✕ Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
- ✕ Active and clinically significant autoimmune or inflammatory disorder requiring active treatment
- ✕ Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
- ✕ Female patients who are pregnant (positive β-HCG) or breastfeeding
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT06799026 · last updated 2026-05-07