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

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05918250
• Other study ID #: mRNA-2736-P101
• Secondary ID: 2023-503286-38-0
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 15, 2023
• Est. completion date: May 27, 2026

Study information

• Verified date: August 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 27, 2026
• Est. primary completion date: May 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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%

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%. 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. Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Biological:
• mRNA-2736
mRNA-2736 will be administered IV.

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	UAB Hospital	Birmingham	Alabama
United States	Ohio State University Hospital	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Miami Health System	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University Medical Center	Saint Louis	Missouri
United States	UW Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events		Up to 1 year
Secondary	Maximum Plasma Concentration (Cmax)		0 (predose) to 96 hours postdose
Secondary	Area Under the Concentration-time Curve (AUC)		0 (predose) to 96 hours postdose
Secondary	Maximum Effect/Concentration of the Expressed Protein (Emax)		0 (predose) to 96 hours postdose
Secondary	Area Under the Effect Concentration (AUEC)		0 (predose) to 96 hours postdose
Secondary	Overall Response Rate (ORR)		Up to 2 years
Secondary	Clinical Benefit Rate (CBR)		Up to 2 years
Secondary	Duration of Response (DOR)		Up to 2 years
Secondary	Progression-free Survival (PFS)		Up to 2 years
Secondary	Overall Survival (OS)		Up to 3 years