Qihan Bio Announces Positive Clinical Results of Allogeneic CAR-T Therapy QT-019B in Multiple Autoimmune Diseases at ASH 2025

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On December 9, Hangzhou Qihan Biotech Co., Ltd. announced an oral presentation and multiple poster displays at the 67th American Society of Hematology (ASH) Annual Meeting. The meeting disclosed positive clinical results from the company’s allogeneic CAR-T project, as well as foundational preclinical data supporting the development of its in vivo CAR-T project.

Oral Presentation Highlights Three IIT Datasets Evaluating QT-019B for the Treatment of Multiple Autoimmune Diseases, Enrolling 20 Subjects. The study showed that the treatment was well-tolerated, with no cytokine release syndrome (CRS) events exceeding grade 1, and no reports of immune effector cell-associated neurotoxicity syndrome (ICANS) or severe infections.

In multiple severe autoimmune disease indications, QT-019B demonstrated clinical benefits in 19 subjects who received the therapeutic dose, while one subject who received a sub-therapeutic dose was not included in the efficacy summary:

• Systemic Lupus Erythematosus with Immune Thrombocytopenia (SLE-ITP) (6 cases): 5 cases of complete remission (CR), platelet count returned to normal; 1 case of partial remission (PR).

• Antiphospholipid Syndrome-associated ITP (APS-ITP) (5 cases): 4 cases of CR, platelet count returned to normal.

• Autoimmune Hemolytic Anemia (AIHA) (3 cases): 2 cases CR, hemoglobin returned to normal.

• SLE (2 cases): 1 case met the DORIS remission criteria; 1 case achieved an SRI-4 response at the 2nd month.

• Autoimmune Diseases of the Nervous System (Neuromyelitis Optica Spectrum Disorders and Multiple Sclerosis; 3 Cases): Subjects are still under follow-up.

  
  

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

• Among the 19 subjects treated at FDA-approved therapeutic dose levels, 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 that oligoclonal bands (OCB) and κ free light chains (kFLC) were rapidly and persistently cleared.

  
  

According to the press release from Hangzhou Qihan Biotech Co., Ltd., the universal dual-target CAR-T cell product QT-019B has received approval for new drug clinical trials from the U.S. FDA and China's NMPA for refractory SLE. The FDA has also granted it Fast Track designation for the SLE-ITP indication, and participant enrollment for the Phase 1 clinical trial is actively underway. In addition, based on the "immune privilege" platform, Qihan Biotech is also developing the next-generation product QT-019C, which aims to simultaneously overcome immune rejection and lymphodepletion dependency.

Source: Qihan Biotech