IASO Bio wins China IND approval for in vivo CAR-T therapy IASO208
IASO Bio has received China’s NMPA approval for IASO208, an investigational CD20-targeting in vivo CAR-T therapy, clearing the way for synchronized clinical development in the United States and China. The company plans to start a Phase Ib study directly in the United States for adults with relapsed or refractory B-cell non-Hodgkin lymphoma.
- China’s NMPA approved the IASO208 IND.
- The FDA cleared the IASO208 IND in September 2026.
- A Phase Ib U.S. study will target adults with R/R B-NHL.
- IASO Bio says 11 patients have been dosed in an early study.
- Early IASO208 results will be presented orally at the 2026 ASH Annual Meeting.
China approval follows U.S. FDA clearance
The Investigational New Drug application for IASO208 was approved by China’s National Medical Products Administration, according to IASO Bio. The decision follows the product’s implicit clearance by the U.S. Food and Drug Administration in September 2026.
IASO Bio described IASO208 as the first lentiviral-vector-based in vivo CAR-T product from China to receive an FDA IND clearance. The therapy was developed using the company’s proprietary InTelliCAR™ platform, which is designed to support in vivo CAR-T products targeting diseases including hematologic malignancies, autoimmune diseases and solid tumors.
The China IND is IASO Bio’s first product to receive approval through China’s 30-day expedited review pathway. The company said the approval demonstrates its capabilities across chemistry, manufacturing and controls, nonclinical studies, clinical trial design and communication with regulators.
Phase Ib study planned in the United States
IASO Bio said it will use investigator-initiated trial data generated in China to begin a Phase Ib clinical study directly in the United States. The study will target adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma, or R/R B-NHL.
IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study involving patients with relapsed or refractory B-cell malignancies. The study is assessing safety, tolerability and preliminary efficacy.
Unlike conventional CAR-T treatment, patients in the study are not required to undergo conventional apheresis or lymphodepleting conditioning. They receive a single intravenous infusion of IASO208. IASO Bio said 11 patients have been dosed to date.
The company reported favorable tolerability and promising anti-tumor activity in early data, while describing those findings as a foundation for larger studies in China and the United States. The early results have been selected for an oral presentation at the 2026 American Society of Hematology Annual Meeting, under Abstract #705.
What the decision means for IASO’s platform
The NMPA approval formally moves IASO Bio’s InTelliCAR™ platform into synchronized U.S.-China clinical development. It also supports the company’s strategy of using early clinical data from China in global development programs, although IASO208 remains an investigational therapy.
Jinhua Zhang, IASO Bio’s founder, chairperson and chief executive officer, called the approval “another milestone” for the company’s in vivo CAR-T platform and said it moves IASO208 from “U.S. IND approval” toward “synchronized U.S., China clinical development.”
IASO Bio was founded in 2017 and says its portfolio includes ten products and product candidates. Beyond its approved CAR-T therapy Equecabtagene Autoleucel, the company is developing nine additional candidates, including five in vivo CAR-T therapies. The IASO208 program gives that platform a clinical development path spanning both China and the United States.
