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TBI-2001 is an autologous chimeric antigen receptor T cell (CAR-T) therapy targeting CD19, developed by Takara Bio. It features a next-generation CAR construct designed to activate JAK/STAT signal transduction, which enhances the proliferation and persistence of the engineered T lymphocytes. This results in improved antitumor activity and potential for sustained anti-tumor effects with reduced relapse rates compared to earlier CAR-T therapies. The primary indications under investigation are relapsed or refractory CD19-positive B-cell lymphoma, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). As of April 2025, it is in Phase 1 clinical trials[1][2][3][4][6].
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