The FDA has cleared the investigational new drug (IND) application for IASO208, a CD20-targeted in vivo CAR T-cell therapy, for the treatment of patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), according to a news release from the developer, IASO Bio.1 IASO208 is expected to advance directly into a phase 1b clinical study in the US and is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance.
What is IASO208 and how does it generate CAR-T cells without leukapheresis?
IASO208 was developed using IASO Bio’s proprietary InTelliCAR™ platform and represents a mechanistically distinct approach from conventional autologous CAR-T therapies. Rather than collecting, engineering, and reinfusing a patient’s T cells in the laboratory, IASO208 generates anti-CD20 CAR-T cells directly within the patient’s body.
The therapy is a replication-incompetent, self-inactivating, third-generation lentiviral vector pseudotyped with an engineered COCV-G viral envelope, which enables selective in vivo binding to and transduction of T cells. It carries a second-generation humanized anti-CD20 CAR transgene, directing the resulting CAR-T cells against CD20-expressing malignant B cells. The treatment does not require leukapheresis or lymphodepleting chemotherapy, and is administered as a single intravenous infusion, thus eliminating 2 of the most significant logistical barriers associated with current autologous CAR-T cell therapies, including the weeks-long ex vivo manufacturing timeline that can delay treatment in rapidly progressing disease.
What early data supported the IASO208 IND clearance?
The FDA’s decision was supported by early data from an ongoing investigator-initiated trial in China evaluating IASO208 in patients with relapsed/refractory B-cell malignancies (NCT07309900).2 The trial is a single-arm, open-label dose-escalation study conducted at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, in collaboration with IASO Bio. As of the announcement date, 11 patients have been dosed, with early results demonstrating favorable tolerability and anti-tumor activity, according to the developers.
The Chinese investigator-initiated trial is enrolling patients aged 18 to 75 years with histopathologically confirmed diagnoses of DLBCL (including high-grade B-cell lymphoma), grade 3b follicular lymphoma (FL), DLBCL transformed from indolent FL or marginal zone lymphoma, or primary mediastinal large B-cell lymphoma who have relapsed or are refractory following prior standard immunochemotherapy that included an anti-CD20 monoclonal antibody and an anthracycline-based regimen. Confirmed CD20 positivity on tumor biopsy and an ECOG performance status of 0 to 2 are required for enrollment. The US phase 1b study is expected to evaluate a similar relapsed/refractory B-cell NHL population; its primary end points and specific eligibility criteria will be established through ongoing FDA interactions.
What is the unmet need in relapsed/refractory B-cell NHL?
B-NHL accounts for approximately 85% of all NHL cases. According to GLOBOCAN, approximately 563,000 new NHL cases were diagnosed globally in 2024, with approximately 74,000 new cases estimated in the US that year. Patients with relapsed/refractory B-cell NHL who have progressed through multiple lines of therapy, including CD19-directed CAR-T cell therapies, have limited options and poor outcomes. Manufacturing delays and the requirement for leukapheresis further constrain access to approved CAR-T products, underscoring the rationale for streamlined in vivo delivery approaches.
What is IASO Bio’s broader in vivo CAR-T pipeline and company context?
Founded in 2017 and headquartered in Shanghai and Nanjing, China, with US operations in Pleasanton, California, IASO Bio has established a pipeline of 10 marketed and investigational products. One of the developer’s products, equecabtagene autoleucel (Fucaso; eque-cel) injection, a BCMA-targeted autologous CAR-T cell therapy, is approved in China for patients with relapsed/refractory multiple myeloma who have received at least 3 prior lines of therapy. Beyond IASO208, IASO Bio has 4 additional in vivo CAR-T candidates in IND-enabling stages across hematologic malignancies, autoimmune diseases, and solid tumors.
“The FDA’s clearance of the IND application for IASO208 represents an important milestone for InTelliCAR™, IASO Bio’s proprietary in vivo CAR-T platform, and marks the entry of China-originated cell therapy technologies into the global race in the in vivo CAR-T field,” stated Jinhua Zhang, founder, chairwoman, and chief executive officer of IASO Bio, in the press release.¹ “The FDA’s clearance of IASO208 based on early IIT data from China reflects the regulator’s recognition of the high quality of China’s IIT clinical data.”
References
- IASO Bio’s CD20-targeted in vivo CAR-T therapy IASO208 receives FDA IND clearance. News release. IASO Biotechnology. September 16, 2026. Accessed September 16, 2026. https://tinyurl.com/5apyaz24
- IASO208 injection in the treatment of relapsed/refractory B-cell malignancies. ClinicalTrials.gov. Updated June 1, 2026. Accessed September 16, 2026. https://tinyurl.com/4j5jd2sd
