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NCT Number: NCT07116616

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA-2808

Drug

intravenous

Primary outcomes

  1. Number of Participants with Dose-limiting Toxicity

    Time frame: Up to 28 days

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

    Time frame: Up to 15 months

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 1 year

  2. Area Under the Concentration-time Curve (AUC)

    Time frame: Up to 1 year

  3. Maximum Effect/Concentration of the Expressed Protein (Emax)

    Time frame: Up to 1 year

  4. Area Under the Effect Concentration (AUEC)

    Time frame: Up to 1 year

  5. Overall Response Rate (ORR)

    Time frame: Up to 3 years

  6. Duration of Response (DOR)

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

  8. Overall Survival (OS)

    Time frame: Up to 3 years

  9. Number of Participants with Minimal Residual Disease Negativity Status

    Time frame: Up to 3 years

  10. Number of Participants with Antibodies to mRNA-2808 Derived Proteins

    Time frame: Up to 1 year

  11. Number of Participants with Antibodies to mRNA-2808 Components

    Time frame: Up to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Moderna WeCare Team

CONTACT

[email protected]

+1-866-663-3762

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Aug 11, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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