Qihan Biotech, a biotechnology company dedicated to applying high-throughput, multiplexed gene editing technologies to cell therapy and organ transplantation, announced today that QT-019C has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). QT-019C is a universal allogeneic CAR-T cell therapy independently developed by Qihan Biotech using the company’s proprietary intellectual property. A distinguishing innovation and advantage of QT-019C lies in its potential to reduce or even eliminate the need for patients to receive preconditioning with lymphodepleting chemotherapy before receiving therapy. It is one of the first such products to advance into human clinical trials under an FDA-approved IND.
The application of CAR-T in autoimmune disease has been limited to the most severely affected patients because of the need to precondition patients with lymphodepletion. Qihan has employed its multiplexed gene editing technological innovations to develop QT-019C with the goal of offering a broader range of patients with autoimmune disease a safer and more convenient treatment option. This milestone marks a significant advancement in the field of next-generation off-the-shelf cell therapies.
To address the multiple challenges currently facing universal cell therapies, QT-019C has been developed with a strong focus on clinical needs and incorporates three major innovations aimed at delivering a next-generation therapy that requires minimal lymphodepletion while maintaining safety, efficacy, and affordability:
- QT-019C enables a true “off-the-shelf” supply model. The product significantly reduces patient wait time and streamlines the clinical infusion process, improving treatment accessibility and efficiency.
- Low-lymphodepletion preconditioning with improved safety. Unlike existing universal cell therapy products that require intensive lymphodepletion chemotherapy prior to treatment, QT-019C is designed to explore a low-lymphodepletion approach, potentially reducing treatment-related toxicities and improving safety. This approach may provide a more patient-friendly option, particularly for young female patients, elderly patients, and patients with compromised health and unable to tolerate conventional chemotherapy.
- Comprehensive functional enhancement to reshape the treatment landscape. Through innovative structural and functional optimization, QT-019C demonstrates enhanced performance across multiple key parameters, including target recognition, resistance to immune rejection, activation, and proliferation. The therapy has the potential to deliver superior clinical benefits for patients with autoimmune diseases and to advance universal CAR-T therapy for autoimmune diseases (UCAR-T4AID) into a new era of safer and more accessible treatment.
About QT-019C
QT-019C Cell Injection is an “off-the-shelf” allogeneic CAR-T cell therapy invented and developed by Qihan Biotech. The therapy is engineered from healthy donor leukapheresis products to stably express two distinct CARs targeting CD19 and BCMA. This dual-targeting design allows QT-019C to simultaneously identify and eliminate disease-causing cells expressing CD19 and BCMA.
To mitigate the risk of graft-versus-host disease (GvHD), Qihan Biotech has used its gene editing technology to eliminate T-cell receptor expression on the surface of QT-019C. To further minimize allogeneic immune rejection, Qihan Biotech leverages its proprietary QUIET® platform for multiplex gene editing to reduce immunogenicity. Additionally, the integration of functional enhancement elements improves the expansion and persistence of QT-019C, thereby enhancing the product’s efficacy and durability.
Collectively, these mechanisms significantly enhance the in vivo survival of QT-019C cells, reduce immune-mediated adverse events, and improve the overall safety and efficacy profile of QT-019C Cell Injection.
About Qihan Biotech
Qihan Biotech is a clinical-stage biotechnology company headquartered in Hangzhou, China, founded by Dr. Luhan Yang and Dr. George Church. The company is 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 cell therapies that are safe, effective, and globally accessible.
Forward-looking Statements
This release contains statements including, but not limited to, Qihan’s research development and/or relevant programs, its past, ongoing, and planned research studies, and the potential of Qihan’s research candidate. These and any other statements in this release are based on Qihan management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such statements. These risks and uncertainties include, but are not limited to, the risk that Qihan’s research program may not warrant further development, the risk that results observed in prior studies of Qihan’s research candidates will not be observed in ongoing or future studies involving these candidates, the risk of a delay or difficulties in the developing or transforming of Qihan’s research candidates, the risk that Qihan may cease or delay the research development of any of its candidates for a variety of reasons. Qihan is providing the information in this release as of this date and does not undertake any obligation to update any statements contained in this release as a result of new information, future events, or otherwise. Information concerning therapies and related products contained herein is not intended as medical advice.
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