The regulatory clearance allows IASO Bio to skip early-stage trials and move directly into a Phase 1b study in the United States. This decision follows positive results from an investigator-initiated trial in China, where 11 patients have already received the single intravenous infusion. Early data from these trials indicate the therapy is well-tolerated and demonstrates anti-tumor activity, validating the company's proprietary InTelliCAR platform.
In section Releases
FDA Clears IASO Bio’s In Vivo CAR-T Therapy for U.S. Clinical Trials
With the FDA greenlighting its IND application, IASO Bio has become the first Chinese firm to bring a lentiviral vector-based in vivo CAR-T therapy into American clinical trials. The treatment, IASO208, targets relapsed or refractory B-cell non-Hodgkin lymphoma without the need for traditional leukapheresis or lymphodepleting chemotherapy.
IASO208 functions by generating CAR-T cells directly within the patient’s body, using an engineered viral envelope to selectively target T cells. Jinhua Zhang, CEO of IASO Bio, noted that the FDA's decision recognizes the quality of Chinese clinical data and marks a significant step for the company's broader pipeline, which spans hematologic malignancies, autoimmune diseases, and solid tumors.
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