Qihan Biotech, a clinical-stage company developing off-the-shelf cell therapies for autoimmune diseases and cancer, announced that it has begun dosing in a Phase I/IIa trial of QT-019B, its allogeneic CAR-T therapy for refractory systemic lupus erythematosus (rSLE). 

 

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation (CDE).

 

QT-019B is Qihan’s first-generation allogeneic CAR-T therapy engineered to treat severe autoimmune diseases. Using the company’s immune-privileged platform, the therapy incorporates multiple gene edits to boost expansion, persistence, and resistance to immune rejection. 

 

Derived from healthy donor leukapheresis products, QT-019B is engineered to express two chimeric antigen receptors (CARs) targeting CD19 and BCMA, enabling it to attack cells expressing either antigen. Gene editing also knocks out the T cell receptor (TCR) to reduce the risk of graft-versus-host disease, while additional modifications minimize immune rejection and cytotoxicity.

 

“Refractory systemic lupus erythematosus represents a substantial unmet medical need and urgently calls for innovative therapeutic approaches,” said Mengtao Li, Director at Peking Union Medical College Hospital and principal investigator. 

 

“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, 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.”