FDA Clears IND for IASO208, First China-Originated In Vivo CAR-T to Enter US Clinic
核心洞察
The FDA has cleared the IND application for IASO208 (搜索), a CD20 (搜索)-targeted in vivo CAR-T therapy developed on IASO Bio's InTelliCAR (搜索) platform.
IASO208 (搜索) is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance, and will advance directly to a US Phase 1b study.
The therapy generates anti-CD20 (搜索) CAR-T cells inside the patient without leukapheresis or lymphodepleting chemotherapy, given as a single intravenous infusion.
The U.S. Food and Drug Administration (搜索) has cleared the Investigational New Drug application for IASO208 (搜索), a CD20 (搜索)-targeted in vivo CAR-T therapy developed by IASO Biotechnology (搜索) using its proprietary InTelliCAR (搜索)™ platform, the company announced. IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance, and it is expected to advance directly into a Phase 1b clinical study in the United States for adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (搜索) (R/R B-NHL).
The clearance was supported by early clinical data from an ongoing investigator-initiated trial in China and informed by interactions with the FDA, according to the company.
A Mechanistically Distinct Approach to CAR-T Generation
IASO208 (搜索) differs fundamentally from conventional autologous CAR-T therapies, which require collecting, engineering, and reinfusing a patient's T cells in the laboratory. Instead, the therapy generates anti-CD20 (搜索) CAR-T cells directly within the patient's body.
The agent 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 (搜索) CAR transgene, directing the resulting CAR-T cells against CD20-expressing malignant B cells.
Because the treatment does not require leukapheresis or lymphodepleting chemotherapy and is administered as a single intravenous infusion, it eliminates two 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.
Early Data From the Chinese Investigator-Initiated Trial
The FDA's decision was supported by early data from an ongoing investigator-initiated trial in China evaluating IASO208 (搜索) in patients with relapsed/refractory B-cell malignancies (NCT07309900). 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 encouraging anti-tumor activity, according to the developers. The company described the data as providing a strong foundation for larger and more systematic clinical studies.
The Chinese 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, 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 (搜索) 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.
Unmet Need in Relapsed/Refractory B-Cell NHL
B-cell non-Hodgkin lymphoma accounts for approximately 85% of all NHL cases, making it the largest disease category within NHL. According to GLOBOCAN estimates, approximately 563,000 new cases of NHL were diagnosed globally in 2024, with approximately 1.721 million people living with NHL within five years of diagnosis. In the United States, approximately 74,000 new cases were estimated in 2024, with approximately 256,000 people living with NHL within five years of diagnosis.
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.
Platform Pipeline and Company Context
"The FDA's clearance of the IND application for IASO208 (搜索) represents an important milestone for InTelliCAR (搜索)™, 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," said Jinhua Zhang, founder, chairwoman, and chief executive officer of IASO Bio.
Zhang added that the clearance based on early IIT data from China "reflects the regulator's recognition of the high quality of China's IIT clinical data, and lays a solid foundation for the international development of the platform's pipeline."
Leveraging the InTelliCAR (搜索)™ platform, IASO Bio has established a pipeline of multiple in vivo CAR-T product candidates spanning hematologic malignancies, autoimmune diseases, and solid tumors, with several already in the IND-enabling stage. Beyond IASO208 (搜索), the company has four additional in vivo CAR-T candidates in IND-enabling stages.
Founded in 2017, IASO Bio is a commercial-stage biopharmaceutical company focused on cell therapies and biologics for hematologic malignancies and autoimmune diseases, with operations in Shanghai and Nanjing, China, and Pleasanton, California. The company has a pipeline of 10 marketed and investigational products, including its core product equecabtagene autoleucel (Fucaso; eque-cel) injection, a BCMA (搜索)-targeted autologous CAR-T cell therapy approved in China for relapsed/refractory multiple myeloma (搜索) in patients who have progressed after at least three prior lines of therapy. The company is also developing that product for earlier lines of r/r MM treatment and for autoimmune diseases including myasthenia gravis (搜索), multiple sclerosis (搜索), and systemic lupus erythematosus (搜索)/lupus nephritis (搜索).
IASO Bio's broader pipeline includes three autologous CAR-T cell therapies, five in vivo CAR-T cell therapies, and one antibody drug candidate. The company has also established strategic collaborations with Innovent Biologics (搜索), Sana Therapeutics (搜索), Cabaletta Bio, and Umoja Biopharma (搜索), as well as academic institutions and hospitals.