Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China
Abstract
BACKGROUND
Lately, autologous CD19-targeting chimeric antigen receptor (CAR) T cells have shown excellent efficacy in treatment of autoimmune diseases, but with great safety concerns, such as infections. In this study, we aimed to evaluate the safety, tolerability, and efficacy of allogeneic CD19 CAR natural killer (NK)-cell therapy in patients with relapsed or refractory systemic lupus erythematosus (SLE).
METHODS
In this open-label, single-arm, prospective, first-in-human case series, we evaluated allogeneic CD19 CAR NK-cell therapy in adult patients (aged 18-65 years) with relapsed or refractory SLE at one site in China. Patients who had received at least two previous standard systemic therapies and continued to exhibit moderate-to-severe disease activity were eligible for inclusion. This study consisted of schedule escalation and dose escalation, with schedule escalation from 7 days and dose escalation commencing at 0·75 × 109 CAR NK cells on day 0. All patients received a lymphodepleting conditioning regimen with fludarabine (25 mg/m2 per day) and cyclophosphamide (300 mg/m2 per day) administered daily from days -5 to -3, followed by three CAR NK-cell infusions within a single treatment cycle at identical dose levels and inter-infusion intervals. Dose-limiting adverse events were monitored in patients for 28 days. The primary endpoints of this study were safety and tolerability, including the incidence of dose-limiting toxicities and adverse events according to National…
How strong is the evidence?
Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health. Reported size: 18 participants or records.
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