mRNA-2808 for relapsed or refractory multiple myeloma
A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
This will test whether mRNA-2808 is safe and tolerable for people with relapsed or refractory multiple myeloma who have already received standard therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ModernaTX, Inc. Industry-sponsored |
| Drugs / interventions | chimeric antigen receptor, chemotherapy, immunotherapy, prednisone |
| Locations | 10 sites (Birmingham, Alabama and 9 other locations) |
| Trial ID | NCT07116616 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with relapsed or refractory multiple myeloma who have prior exposure to a proteasome inhibitor, an IMiD, and an anti-CD38 antibody and who meet the study's measurable disease criteria are ideal candidates.
Not a fit: Patients with CNS myeloma, active plasma cell leukemia, or those who received recent cytotoxic therapy or disallowed immunotherapies are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option that helps control disease in patients whose myeloma no longer responds to current therapies.
How similar studies have performed: mRNA-based cancer immunotherapies are a relatively new approach with encouraging early results in some cancers but limited published evidence specifically in multiple myeloma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 9 other locations
- University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States (Recruiting)
- UCSF — San Francisco, California, United States (Not_yet_recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Mass General Brigham — Boston, Massachusetts, United States (Not_yet_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 (Not_yet_recruiting)
- Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Penn Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: +1-866-663-3762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.