CARsgen Claims First Clinical Win For CLDN 18.2 CAR-T In G/GEJ Adenocarcinoma

CARsgen's anti-Claudin 18.2 CAR-T therapy satricabtagene autoleucel has met its endpoint in a pivotal Phase II trial in later-stage gastric/gastroesophageal junction adenocarcinoma, paving the way for a China NDA filing.

3D illustration of T cells attacking a cancer cell (CAR-T cell therapy) - Illustration
Satri-cel is the world's first CAR-T cell therapy candidate that has reported positive results in a pivotal clinical trial for solid tumors. • Source: Shutterstock

CARsgen Therapeutics has claimed the world’s first clinical win for a Claudin 18.2-targeting chimeric antigen receptor (CAR) T-cell therapy in the treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, paving the way for the submission of a new drug application in China in the first half of 2025.

Key Takeaways
  • CARsgen's first-in-class Claudin 18.2-targeting CAR-T therapy satricabtagene autoleucel met its progression-free survival primary endpoint in a pivotal Chinese Phase II trial for the third- and...

The Chinese biotech’s autologous CAR-T candidate satricabtagene autoleucel (satri-cel) met its progression-free survival (PFS) primary endpoint in the pivotal China-only, active-controlled Phase II CT041-ST-01 trial in the third- and later-line...

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