RecruitingPhase 1Phase 2NCT07116616

A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma

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


Sponsor

ModernaTX, Inc.

Enrollment

166 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria7

  • RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
  • 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 Criteria9

  • 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%.
  • 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) within 21 days prior to Day 1 (Baseline).
  • Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to 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).
  • Genetically 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).
  • Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).

Interventions

DRUGmRNA-2808

intravenous


Locations(10)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

UCSF

San Francisco, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Mass General Brigham

Boston, Massachusetts, United States

Tisch Cancer Institute at Mount Sinai

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Penn Medicine

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07116616


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