mRNA-2808 for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial administers mRNA-2808 to participants with relapsed or refractory multiple myeloma to define safety, tolerability, and an appropriate dose. Eligible patients must have prior exposure to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody and must meet measurable disease criteria. The protocol includes early-phase dose-escalation followed by expansion cohorts to collect preliminary activity and safety data. Participants will be followed at study centers with regular clinic visits, labs, and imaging as required to monitor adverse events and signs of response.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Mass General Brigham
  Boston, Massachusetts, United States Recruiting
• Tisch Cancer Institute at Mount Sinai
  New York, New York, United States Recruiting
• Memorial Sloan-Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Moderna WeCare Team
• Email: WeCareClinicalTrials@modernatx.com
• Phone: +1-866-663-3762

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.