On September 16, 2026 IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IASO208, the Company’s proprietary CD20-targeted in vivo CAR-T therapy developed using its InTelliCAR platform.
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IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance. Supported by early clinical data from an investigator-initiated trial (IIT) in China and informed by interactions with the FDA, IASO208 is expected to advance directly into a Phase Ib clinical study in the United States for the treatment of adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).
IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study in China to assess its safety, tolerability, and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. The treatment does not require leukapheresis or lymphodepleting chemotherapy and is administered as a single intravenous infusion. To date, 11 patients have been dosed, with early data demonstrating favorable tolerability and encouraging anti-tumor activity, providing a strong foundation for larger and more systematic clinical studies. IASO Bio will continue to advance the clinical development of IASO208 to further evaluate its safety and efficacy. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, said: "The FDA’s clearance of the IND application for IASO208 represents an important milestone for InTelliCAR, IASO Bio’s proprietary in vivo CAR-T platform, and marks the entry of China-originated cell therapy technologies into the global race in the in vivo CAR-T field. Leveraging the proprietary InTelliCAR platform, IASO Bio has established a pipeline of multiple in vivo CAR-T product candidates spanning hematologic malignancies, autoimmune diseases, and solid tumors, with several of these products already in the IND-enabling stage. The FDA’s clearance of IASO208 based on early IIT data from China reflects the regulator’s recognition of the high quality of China’s IIT clinical data, and lays a solid foundation for the international development of the platform’s pipeline. Going forward, we will continue to advance the clinical development of the InTelliCAR platform pipeline to accelerate global patient access to China-originated cell therapies."
About IASO208
IASO208 is a replication-incompetent, self-inactivating, third-generation lentiviral vector-based therapeutic. It is pseudotyped with an engineered COCV-G viral envelope and carries a second-generation humanized anti-CD20 chimeric antigen receptor (CAR) transgene. Through selective binding to and transduction of T cells in vivo, IASO208 enables the generation of anti-CD20 CAR-T cells directly within the patient’s body.
About Non-Hodgkin Lymphoma (NHL)
Non-Hodgkin lymphoma (NHL) is a group of malignant tumors originating in the lymphatic system. According to GLOBOCAN estimates, approximately 563,000 new cases of NHL were diagnosed globally in 2024, with approximately 1.721 million people living with NHL within five years of diagnosis. In the United States, approximately 74,000 new cases of NHL were estimated in 2024, with approximately 256,000 people living with NHL within five years of diagnosis.1 B-cell non-Hodgkin lymphoma (B-NHL) accounts for approximately 85% of all NHL cases, making it the largest disease category within NHL.
(Press release, IASO Biotherapeutics, SEP 16, 2026, View Source [SID1234670907])