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IASO Bio wins FDA clearance to test an in vivo CD20 CAR-T

Diagram of in vivo CAR-T therapy showing a patient receiving an intravenous infusion of viral vector or nanoparticles that generate CAR T cells inside the body, with a lower panel illustrating those cells binding to and killing pathogenic cells.

Chen et al., Experimental Hematology and Oncology 2025 (CC BY 4.0)CC BY

IASO Bio, based in Shanghai and Nanjing, received FDA clearance of its investigational new drug application for IASO208 on 16 September 2026, in relapsed or refractory B-cell non-Hodgkin lymphoma.

IASO208 targets CD20 on malignant B cells. Like other in vivo CAR-T candidates it is given as a single intravenous infusion and builds the engineered cells inside the patient, using a third-generation self-inactivating lentiviral vector with an engineered COCV-G envelope, developed on the company InTelliCAR platform. The company says the approach requires neither leukapheresis to collect a patient’s cells nor the lymphodepleting chemotherapy that precedes a conventional CAR-T infusion.

The clearance rests on an ongoing investigator-initiated trial in China at Union Hospital, Tongji Medical College, a single-arm open-label dose-exploration study in which eleven patients had been dosed at the time of the announcement, with what IASO Bio reports as favourable tolerability and anti-tumour activity. The therapy is to advance directly into a Phase 1b study in the United States, without a separate Phase 1 dose-escalation stage.

IASO Bio describes IASO208 as the first China-originated lentiviral-vector in vivo CAR-T to receive FDA IND clearance.

Sources

  1. [1]IASO208 Receives FDA IND Clearance for Relapsed/Refractory B-Cell LymphomaCancerNetwork··Article
  2. [2]IASO Bio CD20-targeted in vivo CAR-T cleared for US study in B-NHLAllSci··Article