Articles tagged with: CT053
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Shanghai, China (Press Release) – CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on CARsgen's application for orphan designation of its investigational CT053 CAR T-cell therapy, fully human anti-BCMA (B cell maturation antigen) autologous chimeric antigen receptor (CAR) T cells for the treatment of multiple myeloma. CT053 was previously granted orphan drug designation by the US Food and Drug Administration in August 2019.
"The COMP's adoption of a positive opinion for CT053 orphan drug designation is …
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Shanghai, China (Press Release) – CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).
RMAT designation was based on clinical data from an ongoing CT053 phase 1 study in heavily pre-treated multiple myeloma patients in China. Updated data from CT053 …
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Shanghai, China (Press Release) – CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company, today announced the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma.
PRIME eligibility was based on clinical data from an ongoing CT053 BCMA CAR-T phase 1 study in China. The results from the trial were presented at an oral presentation on September 14, 2019 in Boston at the 17th …
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Shanghai, China (Press Release) – CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company, today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR T-cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (CT053) for the treatment of multiple myeloma.
"FDA orphan designation is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR-T cells," said Dr. Zonghai Li, Founder, CEO and CSO of CARsgen. "CT053 has demonstrated outstanding potency in an exploratory phase 1 …
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Shanghai, China (Press Release) – CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, today announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed / refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA). CT053 has also received IND clearance from the National Medical Products Administration in China four months ago and is the subject of an ongoing phase I clinical …
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Shanghai, China (Press Release) – CARsgen Therapeutics, a clinical-stage company committed to developing chimeric antigen receptor T cell therapies for cancer, today announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed / refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA).
"At the American Society of Hematology meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 …