IASO Bio announced synchronized investigational new drug clearances for its in vivo CAR-T therapy IASO208. The company disclosed this on Wednesday, November 11, 2026. Both the United States FDA and China's NMPA granted the clearances. The dual green light enables coordinated clinical development across primary global sites. The therapy targets the CD20 surface antigen. IASO208 was developed for adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The candidate is built on the proprietary InTelliCAR engineered lentiviral platform. The therapeutic vector delivers CAR constructs directly into circulating T lymphocytes.
Clinical investigators reported on the delivery approach. One investigator statement was released with the announcement. The administration model is off-the-shelf. It bypasses multi-week patient leukapheresis entirely. It also skips centralized bioreactor processing. Those two steps are standard in ex vivo CAR-T production. China's drug evaluation agency cleared the regulatory filing through its expedited 30-day review pathway. The clearance followed precedent U.S. clinical acceptance.
The Phase Ib trial protocol will assess safety and systemic tolerability. It will also measure preliminary cell expansion dynamics across escalating dose cohorts. Investigator-initiated exploratory trials showed encouraging early biological activity. Those trials reported no dose-limiting immunogenic toxicity. The Phase Ib work will build on that early signal. Dose escalation remains the core design feature of the protocol.
IASO Bio plans synchronized patient screening across participating research medical centers. Screening is set to begin throughout early 2027. The company has not disclosed the number of planned enrollment sites. It has also not released target enrollment figures for the Phase Ib study. Participating research medical centers will run screening in parallel across regions. The synchronized approach mirrors the dual regulatory clearances.
