mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Reason given: The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
Key facts
- Where
- Birmingham, Columbus, Houston, Miami, Milwaukee, Nashville, New York, Philadelphia, Seattle, and St Louis, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- UAB HospitalBirmingham, United StatesNo longer taking part
- Ohio State University HospitalColumbus, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of Miami Health SystemMiami, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Sarah Cannon Research InstituteNashville, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- The Mount Sinai HospitalNew York, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- UW Medical CenterSeattle, United StatesNo longer taking part
- Washington University Medical CenterSt Louis, United StatesNo longer taking part
Trial details
- Who runs it
- ModernaTX, Inc.
- Trial code
- NCT05918250EU 2023-503286-38-00
- Record updated
- 18 August 2023
- Original description
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.Read full original descriptionShow less
A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
Inclusion: 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%.
Exclusion: 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 plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. History of plasma cell leukemia is allowed; 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; Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.