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

NCT07116616 | Recruiting Phase 1 FDA Drug

• 1 other identifier: mRNA-2808-P101
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 10

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

Keywords

relapsed or refractory multiple myeloma; RRMM; multiple myeloma; MM

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose-limiting Toxicity

  Up to 28 days

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

  Up to 15 months

Secondary Outcomes (11)

• Maximum Plasma Concentration (Cmax)

  Up to 1 year

• Area Under the Concentration-time Curve (AUC)

  Up to 1 year

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

  Up to 1 year

• Area Under the Effect Concentration (AUEC)

  Up to 1 year

• Overall Response Rate (ORR)

  Up to 3 years

Study Arms (1)

mRNA-2808

EXPERIMENTAL

Participants will receive mRNA-2808.

Drug: mRNA-2808

Interventions

mRNA-2808 DRUG

intravenous

mRNA-2808

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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).

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (10)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

UCSF

San Francisco, California, 94143, United States

NOT YET RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Mass General Brigham

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Tisch Cancer Institute at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

NOT YET RECRUITING

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

NOT YET RECRUITING

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Moderna WeCare Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 17, 2030
• Study Completion (Estimated): June 17, 2032
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (10)