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Official Title

A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

Phase
Phase 1/Phase 2
Sponsor
ModernaTX, Inc.
Enrollment
166
Timeline
Sep 2025 → Jun 2032
About This Study

The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).

Eligibility Criteria

Inclusion Criteria

  • 1RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
  • 2Measurable disease defined as at least 1 of the following:
  • 3Serum M-protein ≥0.5 grams/deciliter
  • 4Urine M-protein ≥200 milligrams (mg)/24-hour
  • 5Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio
  • 6Plasmacytoma with a single diameter ≥2 centimeters
  • 7Bone marrow plasma cells \>30%

Exclusion Criteria

  • 1Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
  • 2Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.
  • 3Radiotherapy 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.
  • 4Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).
  • 5Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).
  • 6Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).
  • 7Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).
  • 8Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).
  • 9Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).

Locations

10 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

University of Alabama at Birmingham Hospital

Birmingham, Alabama 35233

Recruiting

UCSF

San Francisco, California 94143

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →