CARsgen’s CAR-T therapies hit by FDA hold
14 Dec 2023
Cell TherapyPhase 2ImmunotherapyPhase 1
CARsgen Therapeutics disclosed that the FDA recently placed a clinical hold on three of its investigational CAR T-cell therapies due to issues over chemistry, manufacturing and controls processes. The company said that the agency’s move follows the inspection of a manufacturing site located in Durham, North Carolina.
The therapies affected include CT053, an autologous BCMA CAR T-cell product candidate for the treatment of refractory and/or relapsed multiple myeloma. The therapy, also known as zevorcabtagene autoleucel, is under regulatory review in China and is in Phase II/III development in the US. It is partnered with Huadong Medicine in China.
Other drugs hit by the FDA hold include CT041, an autologous CAR T-cell product candidate against the protein Claudin18.2, which is in Phase II development for gastric, pancreatic and gastroesophageal junction cancer. Also affected is CT071, a Phase I autologous CAR T-cell therapy candidate targeting GPRC5D for the treatment of relapsed/refractory multiple myeloma or relapsed/ refractory primary plasma cell leukaemia.
The company said it will “conduct a comprehensive review and improvement on the current good manufacturing practice” at the plant.
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