• Recruiting

NCT03761108: Phase 1/2 - REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Refractory MM

Updated: Sep 24

(LINKER-MM1)

RRMM

First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma

REGN5458 (LINKER-MM1)

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

Regeneron Pharmaceutical


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

 

REGN-5458

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


Learn more

 

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


Learn more

 

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

Click here for details

 

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

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

- 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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