China-based IASO Biotechnology received US FDA IND clearance for IASO208, an in vivo CD20-targeted CAR-T therapy for relapsed/refractory B-cell non-Hodgkin lymphoma, allowing the company to advance the program into US clinical development.
IASO208 uses a lentiviral vector to deliver an anti-CD20 CAR transgene directly into patients, generating CAR-T cells in vivo without the leukapheresis and ex vivo cell-manufacturing steps required for conventional autologous CAR-T therapy. The candidate drug was developed on IASO Bio's InTelliCAR platform.
The FDA clearance was supported by data from an ongoing investigator-initiated trial (IIT) in China, a single-arm, open-label, dose-exploration study in patients with relapsed/refractory B-cell malignancies. Eleven patients had been dosed at the time of the announcement, with IASO Bio reporting favorable tolerability and preliminary anti-tumor activity. The company said the FDA's acceptance of IIT data generated in China as a basis for IND clearance reflects the regulator's recognition of the data quality from that program.
IASO Bio said IASO208 is expected to advance directly into a Phase Ib study in the US, skipping a de novo Phase I dose-escalation stage — a path the company attributed to the existing IIT safety and activity data. No trial initiation date or enrollment target was disclosed.