Actively Recruiting
A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Led by ModernaTX, Inc. · Updated on 2026-05-18
166
Participants Needed
10
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a drug called mRNA-2808 in adults with relapsed or refractory multiple myeloma (RRMM), a type of blood cancer. This Phase 1/2, open-label, multicenter study aims to understand how well participants tolerate the treatment and monitor any dose-limiting toxicities and other adverse events. The study is sponsored by ModernaTX, Inc. and involves participants who have previously been treated with specific therapies for their condition. Participants in this study will receive mRNA-2808 administered intravenously. The study does not mention a placebo or comparator group, focusing solely on the effects and safety of mRNA-2808. Treatment monitoring includes measuring drug concentration in plasma, protein effect levels, and immune response over time. The study may also assess response rates, duration of response, survival, and minimal residual disease negativity over a period extending up to three years. During the study, participants will undergo various evaluations including safety monitoring for dose-limiting toxicity and treatment-emergent adverse events up to 15 months. Researchers will assess pharmacokinetics, immune response, and disease progression through standardized criteria. The total observation period allows for long-term follow-up to evaluate overall survival and response durability. Participants will have regular assessments as part of this open-label study starting from screening through treatment and follow-up.
CONDITIONS
Brief Title
A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma (RRMM)
- Prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody
- Measurable disease defined by at least one of the following: serum M-protein 0.5 g/dL, urine M-protein 200 mg/24h, involved free light chain 100 mg/L with abnormal ratio, plasmacytoma diameter 2 cm, or bone marrow plasma cells >30%
You will not qualify if you...
- Known central nervous system (CNS) myeloma or symptoms of CNS involvement
- Active plasma cell leukemia with peripheral blood plasma cells 20%
- Radiotherapy or cytotoxic chemotherapy within 2 weeks before baseline, except limited palliative radiotherapy
- Antibody-based immunotherapy within 21 days before baseline
- Proteasome inhibitor or immunomodulatory agent therapy within 14 days before baseline
- Autologous hematopoietic cell transplant within 100 days before baseline
- Allogeneic hematopoietic cell transplant within 180 days before baseline
- Genetically modified adoptive cellular therapy within 12 weeks before baseline
- High-dose corticosteroid therapy (>=140 mg prednisone equivalent) within 14 days before baseline
- Other criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 28 days for dose-limiting toxicity assessment; treatment and safety monitoring continue up to 15 months
Participants receive intravenous mRNA-2808 to treat relapsed or refractory multiple myeloma.
Multiple visits during treatment and follow-up for safety and response assessments
Duration - Up to 3 years
Participants are monitored for long-term outcomes including overall response, survival, and antibody development.
Periodic visits for response and survival assessments
Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCSF
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Mass General Brigham
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
5
Tisch Cancer Institute at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
7
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
8
Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Moderna WeCare Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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