Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma

Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma

To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma.

Inclusion Criteria:

1. Positive for serum anti-HTLV-I antibody
2. Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
3. Positive for CCR4
4. Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
5. Received at least one prior chemotherapy
6. Subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first KW-0761 treatment
7. PS of 0 to 2
8. Negative for HBs antigen and for HBV-DNA by a real-time PCR

Exclusion Criteria:

1. A history of transplantation such as hematopoietic stem cells
2. Positive for HCV antibody or HIV antibody
3. Active multiple cancers at the time of starting this clinical study
4. Previous history of allergic reactions after receiving antibody products
5. Requiring continuous systemic treatment with a steroid
6. Requiring such radiotherapy after starting this clinical study
7. Treated with any investigational drug other than KW-0761 within three months