On November 20, 2020 CARsgen Therapeutics, a clinical-stage biopharmaceutical company, reported that data from its global multiple myeloma program will be presented, including two oral presentations and one poster session, at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually December 5-8, 2020 (Press release, Carsgen Therapeutics, NOV 20, 2020, View Source [SID1234571494]).
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Presentations will include updated safety and efficacy results from investigator-initiated clinical studies of CT053 and preliminary data from the ongoing Phase 1 and 1b/2 clinical studies of CT053 in China (LUMMICAR STUDY 1) and the United States (LUMMICAR STUDY 2). CT053 is an investigational anti-BCMA (B cell maturation antigen) autologous chimeric antigen receptor (CAR) T-cell product for the treatment of adult patients with relapsed and/or refractory multiple myeloma.
Results from LUMMICAR-1: A Phase 1 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Chinese Subjects with Relapsed and/or Refractory Multiple Myeloma
Presenting Author: Wenming Chen, MD, PhD, Beijing Chao-Yang Hospital of Capital Medical University, Beijing, China
Date/Time: Poster #1396, Saturday, December 5, 2020: 7:00 AM-3:30 PM PST
Results from LUMMICAR-2: A Phase 1b/2 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Patients with Relapsed and/or Refractory Multiple Myeloma
Presenting Author: Shaji K. Kumar, MD, Division of Hematology, Mayo Clinic, Rochester, MN
Date/Time: Oral #133, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST
Two-Year Follow-up of Investigator-Initiated Phase 1 Trials of the Safety and Efficacy of Fully Human Anti-BCMA CAR T Cells (CT053) in Relapsed/Refractory Multiple Myeloma
Presenting Author: Siguo Hao, MD, PhD, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
Date/Time: Oral #132, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST
About CT053 and LUMMICAR
CT053 is a CAR T-cell therapy that targets B-cell maturation antigen (BCMA), a protein expressed on the surface of malignant and normal plasma cells. The CT053 construct utilizes a fully human anti-BCMA scFv domain, hypothesized to reduce immunogenicity and improve safety. CT053 T cells are proposed to recognize, bind, and eradicate multiple myeloma cells that express BCMA.
CT053 has received regenerative medicine advanced therapy (RMAT) and orphan drug designations from the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) and orphan drug designations from the European Medicines Agency.
CARsgen Therapeutics’ clinical development program for CT053 includes the clinical studies: LUMMICAR STUDY 1 (NCT03975907 Phase 1, China) and LUMMICAR STUDY 2 (NCT03915184 Phase 1b/2, United States and Canada). These are open-label, multicenter studies evaluating the safety and efficacy of CT053 in adult patients with relapsed and/or refractory multiple myeloma. CT053 studies also include three investigator-initiated trials (NCT03380039; NCT03716856; NCT03302403). For more information, visit clinicaltrials.gov.