@article{oai:nagoya.repo.nii.ac.jp:02001663, author = {Saito, Takuro and Kurose, Koji and Kojima, Takashi and Funakoshi, Takeru and Sato, Eiichi and Nishikawa, Hiroyoshi and Nakajima, Jun and Seto, Yasuyuki and Kakimi, Kazuhiro and Iida, Shinsuke and Doki, Yuichiro and Oka, Mikio and Ueda, Ryuzo and Wada, Hisashi}, issue = {4}, journal = {Nagoya Journal of Medical Science}, month = {Nov}, note = {Tregs infiltrate tumors and inhibit antitumor immunity. KW-0761 (Mogamulizumab) is a humanized anti-CCR4 monoclonal antibody that could eliminate activated Tregs with high immunosuppressive activity that express CCR4. In this phase Ib trial, KW-0761 was used as a cancer immunotherapeutic reagent to deplete Tregs in patients with advanced or recurrent solid CCR4-negative tumors. Thirty-nine patients with solid cancer were treated with KW-0761 at a dose of 0.1 or 1.0 mg/kg. The safety, clinical responses, and effects of Treg depletion were analyzed. Any grade and grade 3–4 treatment-related adverse events (AEs) were observed in 36 (92%) and 14 (36%) out of 39 patients, respectively. All treatment-related AEs were manageable. One and 5 patients achieved a partial response and stable disease, respectively, during treatment and were long survivors. The efficient depletion of Treg in peripheral blood was confirmed in both cohorts. Therefore, the administration of KW-0761 was safe, resulting in the depletion of Tregs in peripheral blood and potential immune responses in patients with solid cancer. The combined use of KW-0761 to deplete Tregs and other immunotherapies is a promising approach to augment immune responses.}, pages = {827--840}, title = {Phase Ib study on the humanized anti-CCR4 antibody, KW-0761, in advanced solid tumors}, volume = {83}, year = {2021} }