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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503286-38-00 | Registry Identifier | CTIS (EU) |
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The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
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This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-2736 | Experimental | Participants will receive mRNA-2736. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-2736 | Biological | mRNA-2736 will be administered IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35294 | United States | ||
| University of Miami Health System |
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| 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 |
| Miami |
| Florida |
| 33136 |
| United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Ohio State University Hospital | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UW Medical Center | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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