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.”