mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Biological: mRNA-2736
- Registration Number
- NCT05918250
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mRNA-2736 mRNA-2736 Participants will receive mRNA-2736.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events Up to 1 year
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve (AUC) 0 (predose) to 96 hours postdose Overall Response Rate (ORR) Up to 2 years Clinical Benefit Rate (CBR) Up to 2 years Area Under the Effect Concentration (AUEC) 0 (predose) to 96 hours postdose Progression-free Survival (PFS) Up to 2 years Maximum Plasma Concentration (Cmax) 0 (predose) to 96 hours postdose Maximum Effect/Concentration of the Expressed Protein (Emax) 0 (predose) to 96 hours postdose Duration of Response (DOR) Up to 2 years Overall Survival (OS) Up to 3 years
Trial Locations
- Locations (13)
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Miami Health System
🇺🇸Miami, Florida, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
UAB Hospital
🇺🇸Birmingham, Alabama, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UW Medical Center
🇺🇸Seattle, Washington, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States