Qihan Biotech, a clinical-stage biotechnology company developing off-the-shelf cell therapies for autoimmune diseases and cancer, including allogeneic CAR-T and in vivo CAR-T therapies, today announced it has initiated dosing in a Phase I/IIa clinical study of QT-019B, an allogeneic CAR-T therapy for the treatment of refractory systemic lupus erythematosus (rSLE). The study is being carried out under a US FDA IND, has received US Fast Track Designation for SLE-ITP, and has obtained IND approval from the Chinese Center for Drug Evaluation (CDE).

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. The therapy is derived from healthy donor leukapheresis products and engineered through gene editing to stably express two distinct chimeric antigen receptors (CARs) targeting CD19 and BCMA, enabling simultaneous recognition and elimination of cells expressing either antigen. To reduce the risk of graft-versus-host disease (GvHD), the T cell receptor (TCR) is knocked out though gene-editing. Additionally, multiplex gene-editing strategies are used to confer hypoimmunity, reducing recognition and clearance by the patients’ endogenous T and NK cells. Together, these modifications minimize immune rejection and cytotoxicity while enhancing persistence.

The phase I/IIa clinical trial, QT-019B-001CN, is an open-label, single-arm, multicenter clinical study conducted in patients with rSLE. The protocol includes dose-escalation and dose-expansion stages, and is designed to evaluate the safety, tolerability, and efficacy of QT-019B in patients with rSLE, to obtain pharmacokinetic and pharmacodynamic data, and to determine the recommended dose for pivotal clinical studies.

“Refractory systemic lupus erythematosus represents a substantial unmet medical need and urgently calls for innovative therapeutic approaches,” said Mengtao Li, M.D., Director at Peking Union Medical College Hospital, and the principal investigator of the study. “While autologous CAR-T therapy has enabled immune reset and long-term remission in some patients with SLE, challenges such as limited accessibility remain. We look forward to evaluating the clinical potential of this off-the-shelf CAR-T cell product, which could provide a novel and more accessible treatment option for patients with refractory systemic lupus erythematosus.”

“QT-019B has already been evaluated in investigator-initiated clinical trials involving more than 20 patients with autoimmune diseases,” said Luhan Yang, Ph.D., Founder and CEO of Qihan Biotech. “We are encouraged by the results we have seen to date and believe that QT-019B has the potential to offer an innovative and more accessible treatment option for patients with refractory systemic lupus erythematosus.”

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. For more information, please visit the company's website at www.qihanbio.com.

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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