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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Regulatory

Regulatory
Kite pharma submitted sBLA for Yescarta in indolent non-Hodgkin lymphomas

CAR-T – August 2020 CAR-T – August 2020 Kite submitted supplemental biologics license application (sBLA) to the FDA for Yescarta in R/R indolent non-Hodgkin lymphoma 04 Sep 2020 Yescarta (Axicabtagene ciloleucel; CD19-targeting autologous T cell immunotherapy) – Gilead Sciences/ Kite […]

by Sandhya Ramalingam

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Regulatory
CARsgen gets IND clearance for FIRST claudin18.2-targeted CAR-T-cell therapy in China

CAR-T Digest- August 2020 CAR-T Digest- August 2020 CARsgen Therapeutics received IND clearance from the National Medical Products Administration (NMPA) in China for CT041 CLDN18.2-CAR-T cells 20 Aug 2020 CT041 (Claudin18.2-targeted CAR-T-cell therapy) – CARsgen Therapeutics NMPA has cleared the […]

by Sandhya Ramalingam

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Regulatory
Precision Bio’s CD19 CAR-T received fast track designation for acute lymphoblastic leukemia

CAR-T Digest- August 2020 CAR-T Digest- August 2020 PBCAR0191 (CAR-T) received fast track designation (FTD) from FDA for advanced B-cell precursor acute lymphoblastic leukemia 19 Aug 2020 PBCAR0191 (CD19 targeting allogeneic CAR-T cell therapy) – Precision BioSciences/ Servier Laboratories FDA […]

by Sandhya Ramalingam

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Regulatory
FDA placed a clinical hold on Phase 1 P-PSMA-101 trial in mCRPC

CAR-T Digest- August 2020 CAR-T Digest- August 2020 P-PSMA-101 P1 trial in mCRPC paused because of patient death – being investigated 17 Aug 2020 P-PSMA-101 (PSMA targeting CAR-T cell therapy) – Poseida Therapeutics Poseida Therapeutics Phase 1 clinical trial for […]

by Sandhya Ramalingam

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Regulatory
J&J/Legend Biotech look to China with Cilta-cel with BTD for R/R Multiple Myeloma

CAR-T Digest- August 2020 CAR-T Digest- August 2020 National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) for ciltacabtagene autoleucel 05 Aug 2020 Ciltacabtagene autoleucel (Cilta-cel; LCAR-B38M CAR-T cells; BCMA targeting CAR-T) – Johnson & Johnson/ Legend Biotech The […]

by Sandhya Ramalingam

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