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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07116616Sponsor: ModernaTX, Inc.Last updated: 2026-05-18

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).

Arms & interventions

  • DrugmRNA-2808

    intravenous

Outcome measures

Primary

  • Number of Participants with Dose-limiting Toxicity

    Time frame: Up to 28 days

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 15 months

Secondary

  • Maximum Plasma Concentration (Cmax)

    Time frame: Up to 1 year

  • Area Under the Concentration-time Curve (AUC)

    Time frame: Up to 1 year

  • Maximum Effect/Concentration of the Expressed Protein (Emax)

    Time frame: Up to 1 year

  • Area Under the Effect Concentration (AUEC)

    Time frame: Up to 1 year

  • Overall Response Rate (ORR)

    Time frame: Up to 3 years

  • Duration of Response (DOR)

    Time frame: Up to 3 years

  • Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria

    Time frame: Up to 3 years

  • Overall Survival (OS)

    Time frame: Up to 3 years

  • Number of Participants with Minimal Residual Disease Negativity Status

    Time frame: Up to 3 years

  • Number of Participants with Antibodies to mRNA-2808 Derived Proteins

    Time frame: Up to 1 year

  • Number of Participants with Antibodies to mRNA-2808 Components

    Time frame: Up to 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (10)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233

Recruiting

UCSF

San Francisco, California, 94143

Not Yet Recruiting

Emory University Hospital

Atlanta, Georgia, 30322

Recruiting

Mass General Brigham

Boston, Massachusetts, 02114

Not Yet Recruiting

Tisch Cancer Institute at Mount Sinai

New York, New York, 10029

Recruiting

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Not Yet Recruiting

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting

Penn Medicine

Philadelphia, Pennsylvania, 19104

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting