Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

Inclusion Criteria: 1. Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following: A. ATL (Adult T-Cell Leukemia-Lymphoma) Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody; Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry); B. PTCL (Peripheral T-Cell Lymphoma) Includes Mycosis Fungoides and Sezary Syndrome; 2: Relapsed to the latest standard chemotherapy; 3: Received at least one prior chemotherapy; 4: After 4 weeks from a prior therapy; 5: Have measurable disease; 6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 7: Male or female, at least 20 years and not older than 70 years of age; 8: Signed written informed consent; 9: Stay in hospital for 4 weeks; 10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry); 11: Adequate bone marrow, hepatic and cardiac function including the followings: Neutrophil count ≥ 1,500 /mm3, Platelets ≥ 75,000 /mm3, Hemoglobin ≥ 8.0 g/dL Serum creatinine ≤ 1.5 x ULN; Serum SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5.0 x ULN if considered due to disease involvement in liver); Serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if considered due to disease involvement in liver) Serum calcium ≤ 11.0 mg/dL PaO2 ≥ 65 mmHg or SaO2 ≥ 90% No clinically significant Electrocardiogram abnormality Left Ventricular Ejection Fraction ≥ 50% [by ECHO or MUGA] Exclusion Criteria: Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results; Active tuberculosis; Prior stem cell transplantation; Myocardial infarction (within 12 months prior to the study entry); Concurrent acute or chronic hepatitis, or cirrhosis; Anti-HCV: positive, Anti-HIV: positive Concurrent active malignant disease; Known allergic reaction to antibody therapy; Concomitant treatment with systemic steroids; Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases; Evidence of CNS metastasis at baseline; Prior and Concurrent spinal cord disease; Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study; Female patients who are pregnant or breast feeding; Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards; Treatment with any other investigational agent within the 4 months prior to study entry; For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.