Qihan Biotech has commenced patient dosing in a Phase I/IIa clinical trial of the allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, QT-019B, targeting refractory systemic lupus erythematosus (rSLE).
QT-019B is Qihan Biotech’s first-generation therapy intended for severe autoimmune diseases.
It is developed using the company’s immune-privileged platform and incorporates multiplex gene edits to support cell expansion, persistence and resistance to immune rejection.
The therapy is obtained from healthy donor leukapheresis products to stably express two CARs that target cluster of differentiation 19 (CD19) and B-cell maturation antigen (BCMA), allowing the identification and removal of cells bearing either antigen.
The QT-019B-001CN Phase I/IIa multi-centre, single-arm, open-label clinical trial involves patients with rSLE.
Qihan Biotech founder and CEO Luhan Yang said: “QT-019B has already been evaluated in investigator-initiated clinical trials involving more than 20 patients with autoimmune diseases.
“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.”
The study protocol comprises both dose-expansion and dose-escalation phases and aims to assess the efficacy, safety, and tolerability of QT-019B for obtaining pharmacodynamic and pharmacokinetic data and determining the recommended dose for pivotal trials.
This trial is being conducted under a US Food and Drug Administration (FDA) investigational new drug (IND) study, has been granted fast track designation for systemic lupus erythematosus - immune thrombocytopenia (SLE-ITP), and secured IND approval from the Chinese Center for Drug Evaluation.
Peking Union Medical College Hospital director and the study principal investigator Mengtao Li said: “Refractory systemic lupus erythematosus represents a substantial unmet medical need and urgently calls for innovative therapeutic approaches. While autologous CAR-T therapy has enabled immune reset and long-term remission in some patients with SLE, challenges such as limited accessibility remain.”
