Study Stopped
The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
2 other identifiers
interventional
N/A
2 countries
13
Brief Summary
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2023
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2026
CompletedAugust 18, 2023
August 1, 2023
2.8 years
June 15, 2023
August 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Adverse Events
Up to 1 year
Secondary Outcomes (9)
Maximum Plasma Concentration (Cmax)
0 (predose) to 96 hours postdose
Area Under the Concentration-time Curve (AUC)
0 (predose) to 96 hours postdose
Maximum Effect/Concentration of the Expressed Protein (Emax)
0 (predose) to 96 hours postdose
Area Under the Effect Concentration (AUEC)
0 (predose) to 96 hours postdose
Overall Response Rate (ORR)
Up to 2 years
- +4 more secondary outcomes
Study Arms (1)
mRNA-2736
EXPERIMENTALParticipants will receive mRNA-2736.
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (13)
UAB Hospital
Birmingham, Alabama, 35294, United States
University of Miami Health System
Miami, Florida, 33136, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
UW Medical Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2023
First Posted
June 26, 2023
Study Start
August 15, 2023
Primary Completion
May 27, 2026
Study Completion
May 27, 2026
Last Updated
August 18, 2023
Record last verified: 2023-08