- Recruiting
NCT03761108: Phase 1/2 - REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Refractory MM
Updated: Sep 24, 2022
(LINKER-MM1)
RRMM
First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma
The primary objectives of the study are:
Phase 1: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended
Phase 2 dose regimen (RP2DR) of REGN5458 as monotherapy in patients with relapsed or refractory Multiple Myeloma (MM) who have exhausted therapeutic options
Phase 2: To assess the preliminary anti-tumor activity of REGN5458
The secondary objectives of the study are: To evaluate the pharmacokinetic (PK) properties of REGN5458, To characterize the immunogenicity of REGN5458
Phase 1: To assess the preliminary anti-tumor activity of REGN5458
Phase 2: To evaluate the safety and tolerability of REGN5458 , To evaluate the correlation between the activity of REGN5458 and PK
Sponsor
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT03761108
Official Title: Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma
First Posted : December 3, 2018
Click here for details on ClinicalTrials.gov
Linvoseltamab (Code C158504)
Anti-BCMA x Anti-CD3 BiTE REGN5458
Anti-BCMA/CD3 BiTE Antibody REGN5458
Bispecific BCMA x CD3 T-cell Engaging Antibody REGN5458
BiTE Antibody REGN5458
Linvoseltamab
LINVOSELTAMAB
REGN 5458
REGN-5458
REGN5458
Drug: REGN5458
anti-BCMA x anti-CD3 BiTE REGN5458
NCT00511238: Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
291 REGN5458, a BCMA x CD3 Bispecific Monoclonal Antibody, Induces Deep and Durable Responses in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Bispecific T Cell Engager Therapies and Novel Targeting Agents
Hematology Disease Topics & Pathways:
Biological, antibodies, Therapies, immunotherapy, Clinically relevant
Saturday, December 5, 2020: 2:15 PM
160 Early, Deep, and Durable Responses, and Low Rates of Cytokine Release Syndrome with REGN5458, a BCMAxCD3 Bispecific Monoclonal Antibody, in a Phase 1/2 First-in-Human Study in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Novel Targets and Amyloid
Hematology Disease Topics & Pathways:
Clinical Trials, Biological, Bispecific Antibody Therapy, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Lymphoid Malignancies
Saturday, December 11, 2021: 12:45 PM
EHA2022 Oral Presentation
EHA 2022 - HYBRID - JUNE 9-17 - VIENNA
EARLY, DEEP, AND DURABLE RESPONSES, AND LOW RATES OF CRS WITH REGN5458, A BCMAXCD3 BISPECIFIC ANTIBODY, IN A PHASE 1/2 FIRST-IN-HUMAN STUDY IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Click here to see Abstract details
COMY 22 - Session 15: Abstract communications
EARLY, DEEP, AND DURABLE RESPONSES, AND LOW RATES OF CYTOKINE RELEASE SYNDROME WITH REGN5458, A BCMAXCD3 BISPECIFIC ANTIBODY, IN A PHASE 1/2 FIRST-IN-HUMAN STUDY IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
OAB-056 Early, deep, and durable responses, and low rates of cytokine release syndrome with REGN5458, a BCMAxCD3 bispecific antibody, in a Phase 1/2 study in patients with relapsed/refractory multiple myeloma -Naresh Bumma
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
https://www.myelomasociety.org/
- Multiple locations
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- New York: Columbia University Medical Center New York
- Florida: Moffitt Cancer Center Tampa
- Florida: Sylvester Comprehensive Cancer Center - University of Miami
- Georgia: Emory University Atlanta
- Michigan: Barbara Ann Karmanos Cancer Institute Detroit
- New Jersey: Rutgers Cancer Institute of New Jersey New Brunswick
- Washington: Swedish Cancer Inst Seattle
Locations
United States, Florida
United States, Georgia
United States, Indiana
United States, Kentucky
United States, Michigan
United States, New Jersey
United States, New York
United States, Ohio
United States, Texas
United States, Washington
Europe
Germany
Belgium
Asia
Korea, Republic of
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