mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Relapsed or Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring mRNA-2736, First-in-human, FIH, Dose-escalation
Eligibility Criteria
Key Inclusion Criteria: RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody. Participants must have received at least 3 prior lines of therapy or be triple-class refractory. Participants that are intolerant of a proteasome inhibitor, IMiD, or aCD38 are eligible. Measurable disease defined as at least 1 of the following: Serum M-protein ≥0.5 grams/deciliter Urine M-protein ≥200 milligrams (mg)/24 hour Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio Plasmacytoma with a single diameter ≥2 centimeters Bone marrow plasma cells >30% Key Exclusion Criteria: Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma. Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. History of plasma cell leukemia is allowed. Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor. Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline). Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline). Immunomodulatory agent therapy within 7 days of Day 1 (Baseline). Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline). Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline). Participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease. Genetically modified adoptive cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline). Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline). Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at the time of screening. Participants with a past or resolved hepatitis B infection (presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if negative for HCV RNA. Note: Other inclusion and exclusion criteria may apply.
Sites / Locations
- UAB Hospital
- University of Miami Health System
- Washington University Medical Center
- Memorial Sloan Kettering Cancer Center
- The Mount Sinai Hospital
- Ohio State University Hospital
- Hospital of the University of Pennsylvania
- Sarah Cannon Research Institute
- MD Anderson Cancer Center
- UW Medical Center
- Medical College of Wisconsin
- Princess Margaret Cancer Centre
- Hôpital Maisonneuve-Rosemont
Arms of the Study
Arm 1
Experimental
mRNA-2736
Participants will receive mRNA-2736.