Conditions: Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL)
Keywords: Adult T-Cell Leukemia ATL Adult Peripheral T-Cell Lymphoma PTCL
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Detailed description:
This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

Arms:
arm 1: KW-0761

Interventions: intervention 1: KW-0761
Intervention descriptions: intervention 1: IV administration at 4 escalating dose levels.

Protocol document: