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NCT07116616PHASE1, PHASE2Recruiting

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

ModernaTX, Inc.

Start Date

9/30/2025

Completion Date

6/17/2032

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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% Key Exclusion Criteria: * 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). Note: Other inclusion and exclusion criteria may apply.

Interventions

DRUG

mRNA-2808

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Conditions

Relapsed or Refractory Multiple Myeloma

Locations

University of Alabama at Birmingham Hospital

Birmingham, Alabama 35233

United States

UCSF

San Francisco, California 94143

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Mass General Brigham

Boston, Massachusetts 02114

United States

Tisch Cancer Institute at Mount Sinai

New York, New York 10029

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Penn Medicine

Philadelphia, Pennsylvania 19104

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States