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On March 12, 2025, Hangzhou Qihan Biotech Co., Ltd. announced that QT-019B, a dual-target universal CAR-T cell product developed based on Qihan’s high-throughput gene editing technology platform, achieved complete remission (CR) at the first efficacy evaluation on day 28 in treating patients with refractory autoimmune hemolytic anemia.
The patient was diagnosed with autoimmune hemolytic anemia in August 2020 and had previously received various drug treatments, including glucocorticoids, rituximab, tacrolimus, sirolimus, cyclophosphamide, intravenous immunoglobulin, and Syk inhibitors, among others. After the failure of the last treatment, the patient enrolled in this clinical study. Following the infusion of CAR-T cells at the protocol-specified dose, the patient only experienced a brief low-grade fever on day 10, which resolved without intervention, and no other adverse events were reported. Currently, the patient's hemoglobin has returned to normal levels, with no evidence of active hemolysis, and the patient reports feeling well and is satisfied with the treatment.Currently, the dual-target universal CAR-T product with the code name QT-019B is being used to treat refractory autoimmune hemolytic anemia, and the company plans to share more clinical data in the second half of 2025.Qihan Biotech is an innovative biotechnology company focused on gene editing and cell therapy. Its R&D pipeline primarily revolves around induced pluripotent stem cells (iPSC) and gene editing technologies. The core product includes QN-019a, an allogeneic CAR-NK cell therapy targeting CD19, which received implied permission for clinical trials from the China National Medical Products Administration in 2023. It is mainly used to treat relapsed or refractory B-cell non-Hodgkin lymphoma. Additionally, the company is developing iPSC-derived CAR-NK cell products for acute myeloid leukemia (AML), as well as various stem cell therapies based on gene editing, aiming to create universal cell therapy products to address the limitations of personalized cell therapy and promote the widespread application of cell therapy technology.Source: Qihan Biotech
