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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05918250

Collaborator

(none)

Enrollment

Locations

Arm

34.5

Anticipated Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Multiple Myeloma	Biological: mRNA-2736	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 12, 2023

Anticipated Primary Completion Date :

May 27, 2026

Anticipated Study Completion Date :

May 27, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-2736 Participants will receive mRNA-2736.	Biological: mRNA-2736 mRNA-2736 will be administered IV.

Arm

Intervention/Treatment

Experimental: mRNA-2736

Participants will receive mRNA-2736.

Biological: mRNA-2736

mRNA-2736 will be administered IV.

Outcome Measures

Primary Outcome Measures

Number of Participants Experiencing Adverse Events [Up to 1 year]

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) [0 (predose) to 96 hours postdose]
Area Under the Concentration-time Curve (AUC) [0 (predose) to 96 hours postdose]
Maximum Effect/Concentration of the Expressed Protein (Emax) [0 (predose) to 96 hours postdose]
Area Under the Effect Concentration (AUEC) [0 (predose) to 96 hours postdose]
Overall Response Rate (ORR) [Up to 2 years]
Clinical Benefit Rate (CBR) [Up to 2 years]
Duration of Response (DOR) [Up to 2 years]
Progression-free Survival (PFS) [Up to 2 years]
Overall Survival (OS) [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Hospital	Birmingham	Alabama	United States	35294
2	University of Miami Health System	Miami	Florida	United States	33136
3	Washington University Medical Center	Saint Louis	Missouri	United States	63110
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
5	The Mount Sinai Hospital	New York	New York	United States	10029
6	Ohio State University Hospital	Columbus	Ohio	United States	43210
7	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
9	MD Anderson Cancer Center	Houston	Texas	United States	77030
10	UW Medical Center	Seattle	Washington	United States	98109
11	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
12	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
13	Hôpital Maisonneuve-Rosemont	Montréal	Quebec	Canada	H1T 2M4