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

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
mRNA-2736
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring mRNA-2736, First-in-human, FIH, Dose-escalation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UAB Hospital
  • University of Miami Health System
  • Washington University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • The Mount Sinai Hospital
  • Ohio State University Hospital
  • Hospital of the University of Pennsylvania
  • Sarah Cannon Research Institute
  • MD Anderson Cancer Center
  • UW Medical Center
  • Medical College of Wisconsin
  • Princess Margaret Cancer Centre
  • Hôpital Maisonneuve-Rosemont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mRNA-2736

Arm Description

Participants will receive mRNA-2736.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Adverse Events

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)
Area Under the Concentration-time Curve (AUC)
Maximum Effect/Concentration of the Expressed Protein (Emax)
Area Under the Effect Concentration (AUEC)
Overall Response Rate (ORR)
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Progression-free Survival (PFS)
Overall Survival (OS)

Full Information

First Posted
June 15, 2023
Last Updated
August 15, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05918250
Brief Title
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Official Title
A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
May 27, 2026 (Anticipated)
Study Completion Date
May 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
Keywords
mRNA-2736, First-in-human, FIH, Dose-escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-2736
Arm Type
Experimental
Arm Description
Participants will receive mRNA-2736.
Intervention Type
Biological
Intervention Name(s)
mRNA-2736
Intervention Description
mRNA-2736 will be administered IV.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Time Frame
0 (predose) to 96 hours postdose
Title
Area Under the Concentration-time Curve (AUC)
Time Frame
0 (predose) to 96 hours postdose
Title
Maximum Effect/Concentration of the Expressed Protein (Emax)
Time Frame
0 (predose) to 96 hours postdose
Title
Area Under the Effect Concentration (AUEC)
Time Frame
0 (predose) to 96 hours postdose
Title
Overall Response Rate (ORR)
Time Frame
Up to 2 years
Title
Clinical Benefit Rate (CBR)
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Time Frame
Up to 2 years
Title
Progression-free Survival (PFS)
Time Frame
Up to 2 years
Title
Overall Survival (OS)
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UW Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

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

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