China's Qihan Biotech has obtained regulatory approval in the US to begin Phase I/II trials of its allogeneic dual-target CAR-T therapy QT-019B for refractory systemic lupus erythematosus (SLE). The therapy simultaneously targets CD19 and BCMA through genetically engineered T-cells from healthy donors, with additional edits to eliminate T-cell receptor expression and reduce immunogenicity. Initial investigator-led studies in China showed promising efficacy across multiple autoimmune diseases, prompting prioritisation of lupus as the first indication.

QT-019B represents China's first US-approved off-the-shelf CAR-T candidate for autoimmune disorders, leveraging Qihan's gene-editing platform to overcome graft-versus-host disease risks while maintaining potent B-cell depletion capabilities.

PharmCube's NextBiopharm® database shows that Qihan Bio competes with 12 other developers of CD19/BCMA-targeting CAR-T therapies in SLE. Click here to request a free trial for NextBiopharm®.