Lupus & antiphospholipid syndrome
Efficacy and safety of allogeneic CD19 chimeric antigen receptor (CAR) natural killer (NK)-cell therapy in systemic lupus erythematosus: a case series in China
An erratum to this article was published (Lancet, 20 Dec 2026 ↗)
Authors' conclusion
This study suggests that allogeneic CAR NK-cell therapy is a potent option for treatment of autoimmune diseases
Study context
- Population
- Adults (18–65 years) with relapsed or refractory systemic lupus erythematosus (SLE) with moderate-to-severe disease activity after at least two standard systemic therapies, one site in China17 (94%) female
- Participants
- 18 adults
- Outcome
- Safety and tolerability, incl. incidence of dose-limiting toxicities and adverse events (CTCAE v5.0)
- Follow-up
- 28 days (dose-limiting adverse events)
Methodological detailsopen-label, single-arm, prospective, first-in-human, single-centre, schedule escalation and dose escalation, Enrolled Aug 21, 2023, to June 16, 2024; follow-up ongoing
- Open-label
- Single-arm
- Prospective
- First-in-human
- Single-centre
- Schedule escalation and dose escalation
- Enrolled Aug 21, 2023, to June 16, 2024; follow-up ongoing
Main finding
As reported in the abstract
Safety and tolerability
Dose-limiting toxicities
0
Cytokine release syndrome (grade 1)
one (6%) of 18
Observational data: associations, not effects.
Further findings
DORIS remission and LLDAS, patients with >12 months' follow-up
- Attained DORIS remission and LLDAS: six (67%) of nine patients with more than 12 months' follow-up
Safety
Cytokine release syndrome (grade 1)
- Cytokine release syndrome reported in one (6%) of 18 patients (grade 1)
Neurotoxicity, other CAR NK-cell therapy-related severe adverse events and dose-limiting toxicities
- Neurotoxicity and other CAR NK-cell therapy-related severe adverse events not observed; no dose-limiting toxicities
Original publication
Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China. Lancet. Published 12 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →