By Fineline Cube 
Chinese firm Juventas Cell Therapy Ltd has obtained tacit clinical trial approval in China for its chimeric antigen receptor (CAR)-T cell therapy, inaticabtagene autoleucel (CNCT 19), targeting autoimmune hemolytic anemia (AIHA) in patients who have previously received at least three lines of treatment. This approval marks a significant step forward in the development of novel therapies for rare blood disorders.
Drug Profile and Mechanism
Inaticabtagene autoleucel is a CD19 CAR-T cell therapy product featuring a unique CD19 scFv (HI19a) structure. The therapy is designed to target B cells, which play a central role in autoimmune diseases like AIHA. By redirecting the patient’s own T cells to attack diseased B cells, the therapy offers a promising approach to managing conditions where traditional treatments have failed.
Regulatory Progress and Development Pipeline
The drug is currently awaiting regulatory decisions in China for use in recurrent or refractory large B-cell lymphoma. In November 2023, it received approval in China for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This broader development pipeline highlights Juventas’ commitment to addressing unmet medical needs in both oncology and autoimmune diseases.-Fineline Info & Tech