Typesetting丨Shuicheng WenSince 2017, the U.S. FDA has successively approved 7CAR-T Cell TherapyLaunched for the treatment of blood cancers such as leukemia and lymphoma, demonstrating powerful therapeutic effects.In recent years, CAR-T cell therapy has shown promise in clinical research.Systemic Lupus Erythematosus、Systemic Sclerosis、Idiopathic Inflammatory Myopathy、Myasthenia Gravis、Immune-Mediated Necrotizing Myopathyand many other typesFromAutoimmune diseases have a good therapeutic effect.However, all existing marketed CAR-T cell therapies use genetically engineered immune cells derived from the patients themselves, making the treatment extremely expensive and time- and labor-intensive.Therefore, researchers began to attempt to developOff-the-shelf Universal CAR-T Cell Product, thereby expanding production scale, reducing production costs, decreasing production time, and ultimately improving the accessibility of CAR-T cell therapy to benefit more patients.2025 Year3 Month12 Day，Qihan BiotechAnnounced the development of a project codenamedQT-019B TheDual-Target Universal TypeCAR-T Cell Products, TreatmentRefractoryAutoimmune Hemolytic AnemiaPatient, on the28 Obtained during the first efficacy evaluationComplete Remission（CR）。
It is reported that the patient2020 Year8 Diagnosed with autoimmune hemolytic anemia in the past month, having received various medications including glucocorticoids, rituximab, tacrolimus, sirolimus, cyclophosphamide, and intravenous immunoglobulin.Syk Inhibitors, etc. After the failure of the last treatment, the patient participated in this clinical study. The patient received the prescribed dose according to the protocol.CAR-T After cell infusion, only on day10 The patient experienced a brief period of low-grade fever, which resolved on its own without intervention, and no other adverse events were reported. Currently, the patient's hemoglobin has returned to normal, with no evidence of active hemolysis, and the patient reports feeling well and is satisfied with the treatment.
Currently, the code name isQT-019B Dual-Target Universal TypeCAR-T The product is being used to treat refractory autoimmune hemolytic anemia.Qihan BiotechPlanned in2025 More clinical data will be shared in the second half of the year.
Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeShi JunThe professor said,The Hematology Research Institute has always been committed to exploring innovative treatment methods to improve patients' therapeutic outcomes and quality of life. This preliminary 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.
Founder and CEO of Hangzhou Qihan Biotech Co., Ltd.Yang LuhanaIndicates,We are very pleased to see the exciting preliminary efficacy of Qihan's cell therapy products in patients, which also gives us a glimpse of the potential for universal applications.The tremendous potential of CAR-T therapy. We sincerely thank the research team for their strong support and the patients for their cooperation. We hope to create a world where cell and organ therapies are accessible to every patient as soon as possible, allowing every patient to benefit from the well-being brought by technological advancements.
Related Reading：
January 9, 2025, Hangzhou Qihan Biotech Co., Ltd.Yang Luhahnand Zhejiang UniversityYellow River、Hu YongImmortal、Wang DongruiWaiting in the Cell Sub-JournalCell Reports MedicinePublished an article titled:CD70-targeted iPSC-derived CAR-NK cells display potent function against tumors and alloreactive T cellsResearch Paper.
The study shows that quadruple gene-edited, CD70-targeted iPSC-derived NK cells ——70CAR-iNK, which can effectively target tumor cells and allogeneic T cells, while achieving broad tumor type coverage, superior proliferation ability, and enhancedAntibody-Dependent Cell-Mediated Cytotoxicity（ADCC）And resistance to allogeneic T-cell rejection has great potential in overcoming the current limitations of cell therapy.Is the next generation of universal immune cell therapyA strong candidate.In this latest study, the research team believes that,CD70Targeted NK cells may be a promising candidate for reducing allogeneic rejection.The research team previously developed a platform for human induced pluripotent stem cells.（iPSC）Source of NK Cells（iNK）The robust differentiation and expansion. Compared with NK cells isolated from peripheral blood or umbilical cord blood, multi-gene edited iPSCs are more feasible, and iPSCs can induce more consistent NK cells on a clinical scale. Using this platform, the research team developed a type of multi-gene modified iNK cell capable of targeting various tumors, named ——70CAR-iNK。In addition, incorporating high-affinity and non-cleavable CD16（hnCD16）When introduced into 70CAR-iNK cells, it can enhance their antibody-dependent cell-mediated cytotoxicity.（ADCC）. The research team also incorporated the IL-15 receptor α/IL-15 fusion protein（IL15RF）, to enhance the persistence of iNK cells without the support of exogenous cytokines, and to prevent by knocking out CD7070CAR-iNK CellsCannibalization。By co-culturing with various tumor cell lines and conducting experiments in xenograft mice models of human lymphoma and renal cell carcinoma, the research team investigated70CAR-iNK CellsThe anti-tumor effect. The research team also analyzed the dynamic changes in surface CD70 expression during the induction of allogeneic reactive T cells and verified the efficacy of 70CAR-iNK cells in inhibiting allogeneic rejection activity.Experimental results showed that quadruple gene-edited 70CAR-iNK cells exhibited potent cytotoxic effects against various tumors. Further validation in xenograft models demonstrated their efficacy in targeting lymphoma and renal cell carcinoma. Additionally, the study found that alloreactive T cells in transplant recipients expressed high levels of CD70, which were eliminated by 70CAR-iNK cells, thereby enhancing the survival and persistence of iNK cells.The study shows that,70CAR-iNKCells with tumor-targeting capabilities and the potential to eliminate allogeneic reactive T cells are strong candidates for the next generation of universal immunotherapy.https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(24)00660-8
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