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MRNA therapy takes on Hard-to-Treat multiple myeloma

NCT ID NCT07116616

Disease control Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests a new drug called mRNA-2808 in people with multiple myeloma that has returned or not responded to standard treatments. The drug is given through a vein and aims to control the cancer. The trial will check for side effects and measure how well the drug works. About 166 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-2808
What this could lead to
If successful, this could provide a new treatment option for people with multiple myeloma that has not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the treatment may not prove effective or safe. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Mass General Brigham

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Penn Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Tisch Cancer Institute at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Alabama at Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

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