Qihan Biotech Presents New Clinical Data on Allogeneic CAR-T Cell Therapies and Preclinical Data on In Vivo CAR-T at the American Society of Hematology (ASH) Annual Meeting

– Clinical data from investigator-initiated trials in 20 patients with multiple autoimmune diseases show allogeneic CAR-T QT-019B was generally well tolerated and demonstrated encouraging efficacy –

– QT-019B Phase 1 trials for refractory Systemic Lupus Erythematosus (rSLE), cleared by US FDA and China NMPA, to begin enrolling patients –

– FDA has granted Fast Track Designation to QT-019B for the treatment of Immune Thrombocytopenia occurring in patients with SLE (SLE-ITP) –

– Additional preclinical findings presented at ASH provide the scientific foundation for Qihan’s in vivo CAR-T platform –

ORLANDO, Fla.--(BUSINESS WIRE)--Qihan Biotech, a clinical-stage biotechnology company developing off-the-shelf cell therapies for autoimmune diseases and cancer, including allogeneic CAR-T and in vivo CAR-T therapies, presented an oral and several poster presentations at the 67th American Society of Hematology (ASH) Annual Meeting. The data included encouraging clinical results with the company’s allogeneic CAR-T program and foundational preclinical work supporting its emerging in vivo CAR-T program.

Qihan’s oral presentation highlighted clinical data from 20 patients enrolled in three investigator-initiated trials evaluating QT-019B in multiple autoimmune diseases. Treatment was well tolerated, with no events exceeding Grade 1 CRS and no reported ICANS or serious infections.

Across multiple severe autoimmune indications, QT-019B demonstrated clinical benefit in patients dosed at therapeutically relevant levels (n=19), with one subtherapeutic-dose patient excluded from the efficacy summary.

• SLE-ITP (n=6): 5 complete responses (CR) with normalized platelet counts and 1 partial response (PR)
• APS-associated ITP (n=5): 4 CR with normalized platelet counts
• AIHA (n=3): 2 CR with normalized hemoglobin
• SLE (n=2): 1 DORIS remission and 1 SRI-4 response at Month 2
• Neurological autoimmune diseases (NMOSD and MS; n=3): 2 EDSS stabilization; 1 too soon to assess 

Pharmacokinetic and pharmacodynamic readouts reinforce the potential of Qihan’s immune-privileged platform to deliver durable, systemic immune reset.

• Robust expansion of allogeneic CAR-T cells observed in 17 of 19 patients treated at therapeutic dose levels
• Deep and sustained depletion of pathogenic autoantibodies, consistent with the intended immune-reset mechanism
• In MS, early CSF analyses showed rapid and durable clearance of oligoclonal bands (OCB) and kappa free light chains (kFLC)

Qihan’s QT-019B program is supported by IND clearance for rSLE from both the US FDA and the China NMPA. The FDA has also granted Fast Track Designation for the SLE-ITP indication. Phase 1 enrollment is actively underway.

Qihan’s unique “immune-privileged” platform – built on the company’s world-leading capabilities in multiplexable gene editing and deep understanding of transplantation immunology – enables creation of next-generation cells capable of evading immune attack. The platform is uniquely designed to address the biological and translational barriers that have limited progress across the CAR-T field. A primary barrier is immune rejection, where host T and NK cells rapidly eliminate donor cells, limiting expansion and persistence, and preventing cells from surviving long enough to achieve durable clinical benefit. Another major challenge is the need for lymphodepletion, which is associated with organ damage and broad toxicities. Qihan is developing the next generation product QT-019C, which aims to overcome both immune rejection and the dependence on lymphodepletion. Across its oral and poster sessions, the company has demonstrated scientific rigor, clinical relevance, and platform scalability that collectively address these critical obstacles.

“Autologous therapies have shown what cell therapy can achieve, but they are not scalable for autoimmune disease. Efforts to develop off-the-shelf allogeneic approaches have been challenging due to immune rejection, limited expansion and persistence, and the need for lymphodepletion. Our data show a different path,” said Luhan Yang, Ph.D., Chief Executive Officer of Qihan Biotech. “Our first-generation program demonstrates strong safety, robust in vivo expansion, meaningful efficacy, and evidence of immune reset. Our next-generation product, which is now in human testing in an IIT, goes further. By driving deeper hypoimmunity and enhanced expansion and persistence, it provides the possibility to eliminate lymphodepletion. We believe we are overcoming the key barriers that have constrained the field and opening the door to broadly accessible, off-the-shelf cell therapies.”

Details of the oral and posters being presented are as follows:

Designing immune-evasive UCAR-T cells to overcome allogeneic barriers and advance off-the-shelf immunotherapy
Publication Number: 1045 (Oral Session)
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Refining CAR-T Cells and Engineered HSPCs; New Approaches to HSPC mobilization
Session Date & Time: December 8, 2025, at 4:30PM – 4:45 PM EST

Engineering Quiescent Viral Entry Pathways for in Vivo CAR-T Generation via Binder-Fusogen Combinatorics
Publication Number: 2404
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster I
Session Date & Time: December 6, 2025, at 5:30PM – 7:30 PM EST

Cytokine receptor armored CAR-T cells enable robust T cell expansion and function in the absence of lymphodepletion
Publication Number: 4104
Session Title: 702. CAR-T Cell Therapies: Basic and Translational: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Enhanced vsvg variants for binder‑dependent and high‑specificity transduction of primary T cells
Publication Number: 4181
Session Title: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Rapid normalization of platelet counts in patients with refractory thrombocytopenia associated with systemic lupus erythematosus (SLE) following treatment with allogeneic dual-target CD19/BCMA CAR T-cell therapy (QT-019B)
Publication Number: 3031
Session Title: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II
Session Date & Time: December 7, 2025, at 6:00PM – 8:00 PM EST

Allogeneic Dual-Target CD19/BCMA CAR T-Cell Therapy (QT-019B) for Refractory Autoimmune Hemolytic Anemia
Publication Number: 5922
Session Title: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Session Date & Time: December 8, 2025, at 6:00PM – 8:00 PM EST

About QT-019B
QT-019B is Qihan Biotech’s first-generation allogeneic CAR-T therapy designed to treat severe autoimmune diseases. Engineered using Qihan’s immune-privileged platform, QT-019B incorporates multiplex gene edits to enhance expansion, persistence, and resistance to immune rejection. QT-019B has demonstrated encouraging safety and clinical activity in multiple investigator-initiated trials and has been cleared by US FDA and China NMPA for further clinical development. QT-019B has received FDA Fast Track Designation for SLE-ITP.

QT-019B has been evaluated in the following autoimmune diseases:
SLE: Systemic Lupus Erythematosus
SLE-ITP: Systemic Lupus Erythematosus–associated Immune Thrombocytopenia
APS-ITP: Antiphospholipid Syndrome–associated Immune Thrombocytopenia
AIHA: Autoimmune Hemolytic Anemia
MS: Multiple Sclerosis
NMOSD: Neuromyelitis Optica Spectrum Disorder

About Qihan Biotech
Qihan Biotech is a biotechnology company advancing off-the-shelf cell therapies through multiplex genome editing, synthetic biology, and scalable GMP manufacturing. Qihan’s mission is to deliver next-generation, immune-privileged off-the-shelf cell therapies that are safe, effective, and globally accessible. Qihan Biotech is headquartered in Hangzhou, China. For more information, please visit the company's website at www.qihanbio.com.