Qihan Biotech, a clinical-stage biotechnology company focused on advancing cell therapies and organ transplantation technologies through high-throughput multiplex gene editing, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its universal allogeneic CAR-T cell therapy candidate, QT-019C.

The milestone enables the company to advance QT-019C into human clinical trials and marks a development in next-generation off-the-shelf cell therapy research aimed at treating autoimmune diseases.

QT-019C has been independently developed by Qihan Biotech using the company’s proprietary gene-editing platform. One of the therapy’s distinguishing features is its potential to reduce or eliminate the need for extensive lymphodepleting chemotherapy before treatment — an approach currently required in many CAR-T therapies and often associated with safety concerns and treatment limitations.

The need for intensive preconditioning has historically limited CAR-T therapy use in autoimmune diseases primarily to severely affected patients. Qihan aims to broaden access to treatment by developing a safer and more patient-friendly therapy option that could benefit a wider patient population.

The company stated that QT-019C incorporates three major innovations designed to improve clinical outcomes while enhancing accessibility and affordability.

The therapy is designed as a true ‘off-the-shelf’ treatment model, allowing immediate availability without the lengthy manufacturing timelines associated with personalised cell therapies. This approach is expected to reduce patient wait times and streamline clinical administration processes.

QT-019C also explores a low-lymphodepletion treatment approach intended to minimise treatment-related toxicities while improving safety profiles. The strategy may particularly benefit patients who may struggle to tolerate conventional chemotherapy, including elderly individuals, patients with compromised health conditions and younger female patients.

Additionally, Qihan has integrated structural and functional enhancements into the therapy to improve target recognition, immune resistance, cellular activation and proliferation. The company believes these optimisations may enhance long-term treatment effectiveness and support broader adoption of universal CAR-T therapies in autoimmune disease management.

QT-019C is engineered from healthy donor leukapheresis material and is designed to express two chimeric antigen receptors (CARs) targeting CD19 and BCMA simultaneously. The dual-targeting mechanism allows the therapy to identify and eliminate disease-driving cells carrying either biomarker.

To improve safety, Qihan has used its multiplex gene-editing technologies to eliminate T-cell receptor expression and reduce the risk of graft-versus-host disease. The company also applies its proprietary QUIET multiplex editing platform to minimise immune rejection while incorporating functional enhancement elements intended to strengthen cell expansion, persistence and treatment durability.

Collectively, these mechanisms are designed to improve in vivo survival of therapeutic cells while reducing immune-related complications and strengthening overall efficacy.

Founded by Dr. Luhan Yang and Dr. George Church, Qihan Biotech focuses on advancing scalable off-the-shelf cell therapies through multiplex genome editing, synthetic biology and manufacturing technologies. The company’s long-term objective is to develop immune-privileged therapies that improve safety, accessibility and treatment outcomes for patients globally.