Hangzhou-based Qihan Biotech has announced significant advancements in universal CAR-T cell therapy research at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in New Orleans. The company's breakthrough centers on enhancing CAR-T efficacy without the need for lymphodepletion preconditioning, potentially expanding treatment applications to autoimmune diseases.
Through systematic exploration of T cell cytokine pathways, Qihan's research team identified two novel cytokines that substantially boost CAR-T cell activity. By engineering the corresponding receptor pathways, they achieved robust CAR-T expansion in non-human primate models without requiring lymphodepletion preconditioning—a process typically necessary for current CAR-T therapies but associated with significant side effects.
"This research marks a significant step forward in CAR-T therapies," stated Dr. Luhan Yang, Founder and CEO of Qihan Biotech. "Enhancing CAR-T efficacy without lymphodepletion and toxicity could unlock its full potential in treating autoimmune diseases. We plan to begin clinical studies in 2025."
Novel Approach to CAR-T Optimization
The research findings, presented as poster #1761 titled "Enhanced CAR-T cell functions without lymphodepletion via engineering cytokine pathways," demonstrate a promising strategy to optimize CAR-T therapies. Current CAR-T treatments typically require lymphodepletion—the temporary depletion of a patient's lymphocytes—to create "space" for the engineered T cells to expand. This process, while effective, carries significant toxicity risks.
Qihan's approach could eliminate this requirement, potentially making CAR-T therapy safer and more accessible to patients with various conditions beyond cancer, particularly autoimmune diseases where the risk-benefit calculation of lymphodepletion has limited CAR-T applications.
Expanding CAR-T Applications
The ability to achieve robust CAR-T expansion without lymphodepletion represents a significant advancement in the field. Current CAR-T therapies are primarily used for treating certain blood cancers, with their application in autoimmune diseases limited by concerns about the additional immunosuppression caused by lymphodepletion in already immunocompromised patients.
Dr. Yang emphasized that this breakthrough could pave the way for broader clinical applications of CAR-T therapies. The company's findings suggest their engineered CAR-T cells demonstrated enhanced activity without observable toxicity in non-human primate models, a crucial step toward human clinical trials.
Company Background and Pipeline
Qihan Biotech specializes in applying multiplexable genome editing technology to develop novel cell therapies and organs for transplantation. The company has raised two financing rounds and has multiple products at different development stages.
One of their lead candidates, QN-019a, has already received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
The company's headquarters in Hangzhou, China, houses their research operations focused on creating immunologically privileged allogeneic cells and xenogeneic organs for treating cancer, autoimmune diseases, organ failure, and other complex medical conditions.
Future Directions
With clinical studies planned for 2025, Qihan Biotech is positioning itself at the forefront of next-generation CAR-T therapies. The elimination of lymphodepletion requirements could significantly reduce treatment-associated risks and expand the patient population that could benefit from these therapies.
The ASGCT Annual Meeting, held May 13-17, 2025, in New Orleans, continues to be a premier forum for presenting cutting-edge research in gene and cell therapy, with this year's focus including advances in treating rare diseases and autoimmune conditions.
As CAR-T therapy continues to evolve, innovations like those presented by Qihan Biotech may help address current limitations and expand treatment options for patients with previously untreatable or difficult-to-manage conditions.
