Qihan Bio Announces Clinical Data of Off-the-Shelf CAR-T Therapy QT-019B in Multiple Autoimmune Diseases and Preclinical In Vivo CAR-T Results

Dec 09, 2025 18:30 CST Updated 18:30

Qihan Biotech

Gene Editing Technology Developer

Editor | Wang Duoyu

Typesetting │ Shuicheng Wen

December 9, 2025At the 67thAmerican Society of Hematology（ASH）At the annual meeting,Qihan BiotechGave an oral presentation and multiple poster presentations, announcing itsAllogeneic CAR-T ProjectPositive clinical outcomes, as well as support for themin vivoCAR-T ProjectDevelopment-based preclinical data.

Qihan BiotechThe oral report highlighted three assessmentsQT-019BTreat a variety ofAutoimmune DiseasesThe IIT clinical data included a total of 20 subjects. The treatment was well-tolerated, with no cytokine release syndrome exceeding grade 1.（CRS）The event, and no immune effector cell-associated neurotoxicity syndrome was reported.（ICANS）Or severe infection.

QT-019BIt is an "off-the-shelf" allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd., which uses the leukocyte apheresis product from healthy donors' peripheral blood as the starting raw material. It undergoes gene editing to stably express two different chimeric antigen receptors.（CAR）, targeting CD19 and BCMA respectively, thereby enabling QT-019B to simultaneously recognize and eliminate cells expressing CD19 and BCMA. Additionally, to reduce graft-versus-host disease（GvHD）Risk: The cell product eliminates the T-cell receptor through gene knockout.（TCR）Expression; Meanwhile, to reduce allogeneic immune rejection, low immunogenicity is achieved through multiple gene editing, thereby reducing the recognition and cytotoxic effects mediated by the patient's own NK cells and T cells.

QT-019B Demonstrates Clinical Benefit in Multiple Severe Autoimmune Indications: Among 19 Subjects Receiving Therapeutic Doses, with One Additional Subject Receiving Sub-Therapeutic Dose Not Included in Efficacy Summary.

The specific situation is as follows:

Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia（SLE-ITP）, a total of 6 casesSubjectAmong them, 5 cases achieved complete remission with platelet counts returning to normal; 1 case achieved partial remission.
Antiphospholipid Syndrome-Related Immune Thrombocytopenia（APS-ITP）, with a total of 5 subjects, of which 4 achieved complete remission and platelet counts returned to normal;
Autoimmune Hemolytic Anemia（AIHA）, a total of 3 subjects, of which 2 achieved complete remission and hemoglobin returned to normal;
Systemic Lupus Erythematosus（SLE）A total of 2 subjects, with 1 subject meeting the DORIS remission criteria; 1 subject achieving SRI-4 response at the 2nd month.
Autoimmune Diseases of the Nervous System(Neuromyelitis Optica Spectrum Disorders, Multiple Sclerosis), a total of 3 subjects, still under follow-up.

Pharmacokinetic and pharmacodynamic data further confirm the potential of Hangzhou Qihan Biotech Co., Ltd.'s "Immune Privilege" platform to achieve durable, systemic immune resetting.

Among the 19 subjects treated at the FDA-approved therapeutic dose level, robust expansion of allogeneic CAR-T cells was observed in 17 subjects.
Deep and sustained clearance of pathogenic autoantibodies, consistent with the expected immune reset mechanism.
In subjects with multiple sclerosis, early cerebrospinal fluid analysis showed oligoclonal bands.（OCB）Free κ Light Chain（kFLC）Being cleared rapidly and durably.

Hangzhou Qihan Biotech Co., Ltd.'s universal dual-target CAR-T cell product QT-019B has received approvals from the U.S. FDA and China NMPA forRefractory Systemic Lupus Erythematosus（rSLE）The new drug clinical trial approval. The FDA has also granted it Fast Track designation for the SLE-ITP indication, and the enrollment of subjects for the Phase I clinical trial is actively underway.

Qihan Biotech's Unique“Immune Privilege”The platform is built on world-leading multi-gene editing capabilities and a deep understanding of transplant immunology, and is able to create a new generation of cells and organs that can evade immune attacks. The platform is specifically designed to address the constraints facing the entire field.CAR-T Designed to address biological and translational barriers in field development. The primary barrier is immune rejection, namely the hostTCells andNKCells rapidly clear donor cells, limiting their expansion and persistence, and preventing them from surviving long enough to produce lasting clinical benefits. Another major challenge is lymphocyte depletion.(Qing Lin)Pre-treatment dependencies, which are associated with organ damage and extensive toxicity. Hangzhou Qihan Biotech Co., Ltd. is developing next-generation products aimed at simultaneously overcoming immune rejection and lymphodepletion dependency.QT-019C。In this oral presentation and poster exhibition, the company demonstrated its consistent scientific rigor, clinical relevance, and platform scalability to address the aforementioned key challenges.

Founder and CEO of Hangzhou Qihan Biotech Co., Ltd.Yang LuhanaDr. stated,Autologous CAR-T therapy has demonstrated the potential of cell therapy, but its model struggles to meet the scalable treatment needs for autoimmune diseases. The development of universal cell therapies has faced challenges due to immune rejection, limited expansion and persistence, and reliance on lymphodepletion. However, our data points to a different path: our first-generation product has shown strong safety, robust in vivo expansion, meaningful efficacy, and evidence of immune resetting. The development of our next-generation product will go further—by achieving deeper low immunogenicity and enhancing expansion without the need for exogenous cytokines, offering the possibility of eliminating the need for lymphodepletion. Hangzhou Qihan Biotech Co., Ltd. is committed to breaking through technological bottlenecks in the cell therapy field, promoting the accessibility and innovation of off-the-shelf cell therapies, and opening a new chapter for industry development.

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