Recruiting
Phase 1
Phase 2

mRNA-2808

Sponsor:

Moderna

Code:

NCT07116616

Conditions

Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mRNA-2808

Study Details

Brief 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).

Conditions

Relapsed or Refractory Multiple Myeloma

Study ID

NCT07116616

Start date

Sep 30, 2025

Status verified date

Jul, 2026

Completion date

Jun 17, 2032

Anticipated

Primary completion date

Jun 17, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

166 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mRNA-2808

Participants will receive mRNA-2808.

Interventions

mRNA-2808

intravenous

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

+1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

University of Alabama at Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35233

UCSF

Recruiting

San Francisco, California, United States, 94143

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Tisch Cancer Institute at Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Penn Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • relapsed or refractory multiple myeloma
  • RRMM
  • multiple myeloma
  • MM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-07-24.