Multiple Myeloma Clinical Trial
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.
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 â‰¥0.5 grams/deciliter
Urine M-protein â‰¥200 milligrams (mg)/24 hour
Involved free light chain (FLC) â‰¥100 mg/liter and an abnormal FLC ratio
Plasmacytoma with a single diameter â‰¥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 â‰¥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 â‰¥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.
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There are 13 Locations for this study
Birmingham Alabama, 35294, United States
Miami Florida, 33136, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
New York New York, 10029, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Toronto Ontario, M5G 2, Canada
MontrÃ©al Quebec, H1T 2, Canada
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