Qihan Biotech Presents Promising Clinical and Preclinical Data on Allogeneic and In Vivo CAR-T Programs at the 67th ASH Annual Meeting
Qihan Biotech, a clinical-stage biotechnology company developing off-the-shelf cell therapies for autoimmune diseases and cancer, announced new clinical and preclinical findings at the 67th American Society of Hematology (ASH) Annual Meeting. The company showcased an oral presentation along with several poster presentations highlighting progress across its allogeneic CAR-T program and emerging in vivo CAR-T platform. The breadth of data supports Qihan’s vision of delivering scalable, immune-evasive, next-generation therapies capable of transforming treatment for severe autoimmune disorders.
Encouraging Safety and Efficacy from QT-019B in Autoimmune Diseases
The centerpiece of Qihan’s ASH data package was clinical evidence from 20 patients participating in three investigator-initiated trials (IITs) evaluating QT-019B, the company’s allogeneic dual-target CD19/BCMA CAR-T cell therapy. Patients enrolled spanned multiple severe autoimmune diseases, including systemic lupus erythematosus (SLE), SLE-associated immune thrombocytopenia (SLE-ITP), antiphospholipid syndrome-associated ITP (APS-ITP), autoimmune hemolytic anemia (AIHA), neurological autoimmune diseases, and multiple sclerosis (MS).
Across the treated population, QT-019B demonstrated a favorable safety profile. No patient experienced ICANS, serious infections, or cytokine release syndrome (CRS) events above Grade 1. These results underscore QT-019B’s tolerability, especially given the complexity of autoimmune conditions and the significant immune dysregulation present in such patients.
Of the 20 treated patients, 19 received therapeutically relevant doses and were included in the preliminary efficacy assessment. Strong clinical responses were reported across disease categories:
- SLE-ITP (n=6): 5 complete responses (CR) marked by normalized platelet counts, and 1 partial response (PR).
- APS-associated ITP (n=5): 4 complete responses with platelet normalization.
- AIHA (n=3): 2 complete responses with normalization of hemoglobin levels.
- SLE (n=2): 1 achieved DORIS remission; 1 showed positive SRI-4 response at Month 2.
- Neurological autoimmune disorders (n=3, NMOSD and MS): 2 patients achieved EDSS stabilization, with one patient too early for assessment.
These encouraging responses are amplified by supporting pharmacokinetic and pharmacodynamic data. Notably, robust in vivo expansion of QT-019B cells was detected in 17 of 19 therapeutically dosed patients. This degree of expansion and persistence highlights the strength of Qihan’s “immune-privileged” approach, aimed at enabling donor-derived cells to withstand immune rejection.
Furthermore, patients displayed deep and sustained reductions in pathogenic autoantibodies—a key therapeutic objective for immune reset therapies. In MS specifically, early cerebrospinal fluid analyses revealed rapid and durable clearance of oligoclonal bands (OCB) and kappa free light chains (kFLC), indicators of intrathecal inflammation.
Regulatory Milestones and Clinical Advancement
Qihan’s growing clinical momentum for QT-019B is reinforced by recent regulatory achievements. Both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have granted Investigational New Drug (IND) clearances for Phase 1 trials of QT-019B in refractory systemic lupus erythematosus (rSLE). Additionally, the FDA has awarded Fast Track Designation for QT-019B in the treatment of SLE-associated immune thrombocytopenia (SLE-ITP), reflecting significant unmet need and therapeutic promise.
With regulatory clearances in place, patient enrollment in Phase 1 trials is now underway. Qihan is advancing its program to evaluate durability, expansion characteristics, and the therapy’s potential to deliver long-term immune modulation without the burdens associated with autologous CAR-T manufacturing.
A Platform Built for Immune Evasion and Scalable Therapeutics
A major theme across Qihan’s presentations at ASH was the company’s proprietary immune-evasive technology platform. Constructed through advanced multiplex gene editing and deep insights into transplantation immunology, the platform aims to generate allogeneic CAR-T cells capable of:
- Evading detection by host T cells
- Avoiding elimination by innate immune cells, including NK cells
- Expanding and persisting in recipients to induce durable immune reset
- Reducing reliance on toxic lymphodepletion regimens
Traditional allogeneic CAR-T development is hindered by rapid host-versus-graft immune rejection. Host immune cells often clear donor-derived CAR-T cells before they can exert clinical benefit. Additionally, current CAR-T paradigms depend heavily on lymphodepletion to support T cell expansion—introducing toxicity, organ risks, and immune suppression.
Qihan’s approach addresses these barriers by engineering immune-privileged cells that circumvent host rejection pathways. Building on the success of QT-019B, the company is developing the next-generation product QT-019C, designed for even deeper hypoimmunity and improved persistence. Early IIT testing suggests QT-019C may enable CAR-T function without lymphodepleting chemotherapy—an advancement that could redefine the safety and accessibility of CAR-T therapy.
Our data show a different path forward for cell therapy,” stated Luhan Yang, Ph.D., Chief Executive Officer of Qihan Biotech. “Autologous products have demonstrated remarkable potential, but they are not scalable for widespread autoimmune disease. The field has struggled with immune rejection, limited expansion, insufficient persistence, and the need for lymphodepletion. Our platform overcomes these barriers by delivering strong safety, robust in vivo expansion, and meaningful clinical benefit. We believe we are opening the door to widely accessible, off-the-shelf cell therapies.”
Advancing In Vivo CAR-T Through Foundational Preclinical Data
Beyond allogeneic CAR-T, Qihan is building a cutting-edge in vivo CAR-T platform engineered to generate CAR-T cells directly within the patient’s body. At ASH, the company presented key preclinical data supporting this technology, demonstrating scientific innovation and translational feasibility.
Preclinical highlights included:
- Engineering Quiescent Viral Entry Pathways for in Vivo CAR-T Generation:
Research showcased binder-fusogen combinatorial strategies enabling precise, efficient targeting of primary T cells, a crucial step for safe in vivo CAR-T creation. - Cytokine Receptor Armored CAR-T Cells:
Data demonstrated that equipping CAR-T cells with cytokine receptor enhancements enables strong T-cell expansion and functionality without requiring lymphodepletion—a major breakthrough for patient safety and treatment scalability. - Enhanced VSV-G Variants for High-Specificity Transduction:
Poster data revealed the design of improved VSV-G envelope proteins capable of binder-dependent, highly specific transduction of T cells, critical for in vivo CAR-T precision.
Together, these findings form the scientific foundation for Qihan’s in vivo CAR-T platform and reinforce its potential to overcome manufacturing, distribution, and cost barriers associated with ex vivo cell therapy.
ASH Presentations Overview
Qihan presented the following oral and poster sessions:
- Designing Immune-Evasive UCAR-T Cells
Oral Session, Publication #1045 – December 8, 2025 - Engineering Quiescent Viral Entry Pathways for In Vivo CAR-T Generation
Poster, Publication #2404 – December 6, 2025 - Cytokine Receptor Armored CAR-T Cells Supporting Function Without Lymphodepletion
Poster, Publication #4104 – December 7, 2025 - Enhanced VSV-G Variants for High-Specificity Transduction
Poster, Publication #4181 – December 7, 2025 - Rapid Platelet Normalization in Refractory SLE-ITP Treated with QT-019B
Poster, Publication #3031 – December 7, 2025 - Allogeneic Dual-Target CD19/BCMA CAR-T Therapy for Refractory AIHA
Poster, Publication #5922 – December 8, 2025
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.
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.
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