Argx 110 for treatment of CD70 positive advanced cutaneous T cell lymphoma in a phase 1/2 clinical trial

MethodsAs part of a non-randomized, open-label, multicenter Phase 1/2 study (NCT01813539), a total of 27 patients with CD70-expressing advanced CTCL of different subtypes and stages were included for determination of the optimal dose, to evaluate exploratory efficacy and safety, and to characterize pharmacokinetics and biomarkers of drug activity (immunohistochemistry [IHC] staining for drug-and disease-related markers, profiling of malignant and non-malignant immune cells by flow cytometry, quantitative polymerase chain reaction [qPCR] and Nanostring). ARGX-110 was administered intravenously at 1 (N= 11) or 5 mg/kg (N= 16) every three weeks (Q3W). Adverse events were graded according to NCI-CTCAE v. 4.03.Results