IASO Bio $IASO208 Therapy Cleared by FDA for Clinical Trials

IASO Biotechnology announced on September 16, 2026, that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IASO208. This proprietary CD20-targeted in vivo CAR-T therapy, developed using the company's InTelliCAR™ platform, is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive such clearance from the FDA.

Supported by early clinical data from an investigator-initiated trial in China, IASO208 is expected to proceed directly into a Phase Ib clinical study in the United States. The trial will focus on adult patients diagnosed with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), a condition that accounts for approximately 85% of all NHL cases. The therapy is administered as a single intravenous infusion and has demonstrated favorable tolerability and encouraging anti-tumor activity in preliminary studies.

IASO Bio's leadership highlighted the milestone as a crucial entry point for Chinese cell therapy innovations into the global arena and indicated plans to advance a pipeline of in vivo CAR-T candidates across various indications. ### Money Play

This regulatory clearance represents a validation of IASO Bio's in vivo CAR-T platform and opens the door for further clinical development in the U.S. market. Investors will be monitoring the progress of the Phase Ib trial as it advances the potential of China-originated cell therapies.