mRNA-2808 for Multiple Myeloma

Recruiting at 9 trial locations

Overseen By Moderna WeCare Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ModernaTX, Inc.

Must not be taking: Antibodies, Proteasome inhibitors

Disqualifiers: CNS myeloma, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mRNA-2808 to determine its safety and tolerability for people with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or resisted other treatments. The trial targets those who have already tried specific cancer therapies but still show measurable signs of the disease. Individuals who have used a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody, yet continue to experience symptoms, might be suitable for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications before joining the trial. Specifically, you cannot have had radiotherapy, certain chemotherapy, or specific immunotherapies within a few weeks before starting the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that mRNA-2808 is likely to be safe for humans?

Research shows that mRNA-2808 is undergoing testing to ensure its safety and tolerability for individuals with relapsed or refractory multiple myeloma. Although specific safety data for mRNA-2808 is not yet available, its inclusion in early clinical trials suggests promise from lab studies or earlier tests. These initial trials primarily assess the treatment's safety, with participants under close observation.

If mRNA-2808 demonstrates good safety results in these trials, it could offer new hope for those whose myeloma has not responded to other treatments. Currently, the study is collecting more data to evaluate how well participants tolerate the treatment and to identify any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often include chemotherapy, immunotherapy, or targeted therapy, mRNA-2808 introduces a new approach by using messenger RNA (mRNA) technology. This treatment works by delivering genetic instructions directly into the patient's cells, prompting them to produce a specific protein that can help fight the cancer. Researchers are excited about mRNA-2808 because it represents a novel mechanism of action, potentially offering a more targeted and efficient way to combat multiple myeloma compared to traditional therapies. Additionally, mRNA-based treatments can be rapidly developed and customized, which may lead to quicker advancements in cancer care.

What evidence suggests that mRNA-2808 might be an effective treatment for multiple myeloma?

Research has shown that mRNA-2808, the treatment under study in this trial, targets specific markers on multiple myeloma cells. It uses mRNA to create T-cell engagers, which help the immune system locate and destroy cancer cells. Early studies suggest that this method could be effective for patients whose cancer has returned or hasn't responded to other treatments. Although still under investigation, this therapy could represent a breakthrough for those with hard-to-treat forms of multiple myeloma. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with relapsed or refractory multiple myeloma who have measurable disease, have been treated with specific drugs like proteasome inhibitors and monoclonal antibodies, but haven't had certain therapies like antibody-based immunotherapy or a cell transplant too close to the start of the trial.

Inclusion Criteria

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%

I have relapsed or refractory multiple myeloma and have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody.

Exclusion Criteria

I haven't had antibody immunotherapy in the last 21 days.

I had a stem cell transplant using my own cells within the last 100 days.

I haven't had gene-modified cell therapy in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mRNA-2808 to evaluate safety and tolerability

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-2808

Trial Overview The study tests mRNA-2808's safety and how well it's tolerated in participants. It aims to find out if this new treatment can help those whose multiple myeloma has come back after treatment or hasn't responded to previous treatments.

How Is the Trial Designed?

Group I: mRNA-2808 Experimental Treatment 1 Intervention

Participants will receive mRNA-2808.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116616

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

2. morningstar.com morningstar.com/news/accesswire/1096077msn/moderna-announces-first-patient-dosed-in-phase-12-study-of-investigational-t-cell-engager-for-multiple-myeloma

Moderna Announces First Patient Dosed in Phase 1/2 ... mRNA-2808 is an investigational, multiplexed therapy that encodes three TCEs that target three validated myeloma-associated antigens. This novel ...

3. marketchameleon.com marketchameleon.com/articles/b/2025/11/3/moderna-launches-first-patient-study-mrna-t-cell-engager-multiple-myeloma

Moderna Launches First Patient Study of Multiplexed ... If mRNA-2808 shows promising safety and efficacy in the ongoing study, it could become a game changer for those who develop resistance to ...

4. trial.medpath.com trial.medpath.com/news/4482380006e4996f/moderna-doses-first-patient-in-phase-1-2-trial-of-novel-mrna-t-cell-engager-for-multiple-myeloma

Moderna Doses First Patient in Phase 1/2 Trial of Novel ... Moderna has dosed the first patient with mRNA-2808, an investigational mRNA-based T-cell engager therapy for relapsed or refractory multiple ...

5. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-of-mrna-2808-in-participants-with-relapsed-or-refractory-multiple-myeloma

T-cell engager therapy (mRNA-2808), to treat multiple ... If mRNA-2808 is safe and works well to treat multiple myeloma that has relapsed or is refractory.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07116616

NCT07116616 | A Study of mRNA-2808 in Participants ... The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).

7. biospace.com biospace.com/press-releases/moderna-announces-first-patient-dosed-in-phase-1-2-study-of-investigational-t-cell-engager-for-multiple-myeloma

Moderna Announces First Patient Dosed in Phase 1/2 ... mRNA-2808 is an investigational, multiplexed therapy that encodes three TCEs that target three validated myeloma-associated antigens. This novel ...

8. myeloma.org myeloma.org/sparkcures/trial/2157/NCT07116616/description

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

9. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/multiple-myeloma

UCSF Multiple Myeloma Clinical Trials for 2025 The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma ( ...