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

Moderna

Status and phase: Begins enrollment in 1 month; Phase 2; Phase 1

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: mRNA-2808

Study type: Interventional

Funder types: Industry

Identifiers

NCT07116616

mRNA-2808-P101

Details and patient eligibility

About

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

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

mRNA-2808

Experimental group

Description:

Participants will receive mRNA-2808.

Treatment:

Drug: mRNA-2808