mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT ID: NCT05918250

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2026-05-27

Brief Summary

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This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.

Detailed Description

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This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.

Conditions

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Relapsed or Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mRNA-2736

Participants will receive mRNA-2736.

Group Type EXPERIMENTAL

mRNA-2736

Intervention Type BIOLOGICAL

mRNA-2736 will be administered IV.

Interventions

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mRNA-2736

mRNA-2736 will be administered IV.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody. Participants must have received at least 3 prior lines of therapy or be triple-class refractory. Participants that are intolerant of a proteasome inhibitor, IMiD, or aCD38 are eligible.
* 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%

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%. History of plasma cell leukemia is allowed.
* 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, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline).
* Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline).
* Immunomodulatory agent therapy within 7 days of 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). Participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease.
* Genetically modified adoptive 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).
* Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at the time of screening. Participants with a past or resolved hepatitis B infection (presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if negative for HCV RNA.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UAB Hospital

Birmingham, Alabama, United States

Site Status

University of Miami Health System

Miami, Florida, United States

Site Status

Washington University Medical Center

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The Mount Sinai Hospital

New York, New York, United States

Site Status

Ohio State University Hospital

Columbus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

UW Medical Center

Seattle, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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2023-503286-38-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

mRNA-2736-P101

Identifier Type: -

Identifier Source: org_study_id

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