Qihan Biotech’s 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. 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.
Through structural and functional optimisation, 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 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.
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 minimise allogeneic immune rejection, Qihan Biotech uses its 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.