A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• •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:
• •* 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.
• •Female patients who are pregnant (positive β-HCG) or breastfeeding
• •Prior organ transplant requiring immunosuppressive therapy.
• •Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
• •Eligibility Criteria Prior to Vaccination with DC/MM fusions
• •Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary.
• •Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine
• •Absence of disease progression following 2 cycles of elranatamab therapy
• •ECOG performance status ≤ 2
• •Participants 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
• •ANC \> 1K/uL; Platelets \> 50 K/uL without transfusional support
• •Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal