Qihan Bio Announces Complete Response in First Patient with Refractory Autoimmune Hemolytic Anemia Treated with Allogeneic Dual-Target CAR-T Therapy QT-019B at Day 28

Mar 12, 2025 11:40 CST Updated 11:40

Qihan Biotech

Gene Editing Technology Developer

▎WuXi AppTec Content Team Report

Today (On March 12, Hangzhou Qihan Biotech Co., Ltd. announced the development of its product code-named QT-019B.Dual-Target Universal CAR-T Cell Product for the Treatment of Refractory Autoimmune Hemolytic Anemia Patients, achieving complete remission (CR) at the first efficacy evaluation on Day 28.

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 level has returned to normal, there is no evidence of active hemolysis, and the patient reports feeling well and is satisfied with the treatment.

Qihan Biotech is a biotechnology company in the field of cell therapy and organ transplantation. It aims to leverage its high-throughput gene-editing technology and deep understanding of immune transplantation to develop immune-compatible allogeneic cell therapies and xenotransplantation solutions, bringing hope to millions of patients and their families worldwide. The company has raised over 100 million US dollars in cumulative financing. Currently, its allogeneic cell therapy products have entered investigator-initiated clinical trials, with one product receiving tacit approval for clinical trials from the National Medical Products Administration (NMPA) of China.

Currently, the dual-target universal CAR-T product with the code name QT-019B is being targeted againstRefractory Autoimmune Hemolytic AnemiaPerform treatment,Qihan BiotechPlan to share more clinical data in the second half of 2025.

Professor Shi Jun from the Blood Disease Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences, stated: "The Hematology Research Institute has always been committed to exploring innovative treatment methods to improve patient outcomes and quality of life. This initial success is an affirmation of our multi-faceted efforts and an important milestone in the field of cell therapy. It not only provides valuable data support for future clinical applications but also brings new hope to a wide range of patients. The research is currently still in the patient recruitment phase."

Dr. Luhan Yang, founder and CEO of Hangzhou Qihan Biotech Co., Ltd., stated: "We are very pleased to see the exciting preliminary efficacy of Qihan's cell therapy products in patients, which also demonstrates the tremendous potential of universal CAR-T therapy. We are deeply grateful for the strong support from the research team and the cooperation of the patients. We hope to create a world where cell and organ therapies can be accessible to every patient as soon as possible, allowing every patient to benefit from the well-being brought by technological advancements."

References:

[1] Hangzhou Qihan Biotech Co., Ltd.'s Universal CAR-T Therapy Achieves Complete Remission at Day 28 Evaluation for Refractory Autoimmune Hemolytic Anemia Patient. Retrieved Mar 12, 2025, from https://mp.weixin.qq.com/s/5hJAXDCqW2Zg32WPy9aH9Q

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