Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma

Phase 1/2 Completed 42 enrolled Kyowa Kirin, Inc. Kyowa Hakko Kirin Pharma, Inc. · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This study will determine the maximum dose of KW-0761 administered intravenously that can be given safely in subjects with previously treated peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma(CTCL)and will see if it is effective in treating the disease.

Timeline

Start: 2009-05
Primary completion: 2012-09
Completion: 2012-09

Publications

Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. doi: 10.1182/blood-2014-09-600924. Epub 2015 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mogamulizumab	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Mogamulizumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Mogamulizumab	Monoclonal antibody	1 mg/kg	Intravenous

Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma

Summary

Timeline

Publications

Drugs

Indications