The genetically edited allogeneic product could serve as an immune-modulatory therapy for severe autoimmune diseases, data suggests.

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New clinical data has demonstrated the first application of iPSC-CAR-NK cells in autoimmune disease. The cell-based therapy successfully inducted immune reset in refractory systemic sclerosis (SSc), according to the study findings.

The patient received four doses of the off-the-shelf, dual-targeting cell product QN-139b (6 × 10⁸ cells per dose).

Following six months of treatment, results demonstrated:

  • significant reduction in autoantibodies and normalisation of complement levels
  • dramatic improvement in modified Rodnan skin score (mRSS)
  • enhanced ACR-CRISS score
  • histological evidence of B cell clearance, fibrosis suppression, lymphocyte depletion in affected tissues, and skin microvascular remodelling.

“We are proud to see a patient with nearly two decades of systemic sclerosis achieve such meaningful clinical improvement following QN-139b treatment"

“We are proud to see a patient with nearly two decades of systemic sclerosis achieve such meaningful clinical improvement following QN-139b treatment,” commented Dr Luhan Yang, Founder and CEO of Hangzhou Qihan Biotech Co., Ltd. “Our years of innovation in reducing allogeneic immune rejection now empower not only iPSC-NK but also iPSC-T and universal CAR-T platforms—offering renewed hope for patients with autoimmune diseases worldwide.”

About the iPSC-CAR-NK cell therapy

Qihan Biotech shared that the therapy utilises the company's high-throughput gene editing platform to eliminate pathogenic B cells and plasma cells by targeting both CD19 and BCMA.

One of its safety features includes production from sequenced monoclonal iPSC lines to minimise genomic toxicity. Furthermore, QN-139b includes a tEGFR safety switch which serves to reduce risk of disease flares in those with autoimmune conditions. Its low-immunogenicity design also strengthens its in vivo expansion and therapeutic durability, stated Qihan Biotech.

Findings from the iPSC-CAR-NK cell therapy study were published in Cell.

Looking ahead at future of development of iPSC-NK therapies, “meaningful progress will depend on sustained investment in cell engineering, manufacturing process optimisation, analytical development and regulatory alignment”, wrote Stefan Braam, Co-Founder and Chief Technical Officer, Cellistic, in an EPR article earlier this month.

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