Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

Inclusion Criteria:

1. ≥18 years of age at the time of enrollment;

2. Histologically confirmed diagnosis of PTCL as specified below:

   • PTCL-NOS
   • Angioimmunoblastic T-cell lymphoma
   • Anaplastic large cell lymphoma, ALK-positive
   • Anaplastic large cell lymphoma, ALK-negative
   • Transformed mycosis fungoides
3. Failed or intolerant of at least one prior systemic anticancer therapy;
4. ECOG performance status score of ≤ 2 at study entry;
5. At least one site of disease measurable in two dimensions by computed tomography (CT);
6. Subjects who are positive for CCR4 by immunohistochemistry;
7. Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 (NCI-CTCAE, v.4.0);
8. Adequate hematological hepatic and renal function.

Exclusion Criteria:

1. Subject with the following PTCL diagnoses are excluded;

   • Precursor T/NK neoplasms
   • Adult T-cell leukemia-lymphoma
   • T-cell prolymphocytic leukemia
   • T-cell large granular lymphocytic leukemia
   • Aggressive NK-cell leukemia
   • Systemic EBV-positive T-cell lymphoproliferative disorder of childhood
   • Hydroa vacciniforme-like lymphoma
   • Mycosis fungoides, other than transformed mycosis fungoides
   • Sezary Syndrome
   • Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphatoid papulosis
   • Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell lymphoma
   • Primary cutaneous CD4+ small/medium T-cell lymphoma
   • Primary cutaneous gamma-delta T-cell lymphoma
   • Extranodal NK/T T-cell lymphoma-nasal type
   • Enteropathy-associated T-cell lymphoma
   • Hepatosplenic T-cell lymphoma
   • Subcutaneous panniculitis -like T-cell lymphoma
   • Chronic lymphoproliferative disorder of NK cells
2. Have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or localized prostate cancer with a current PSA of ≤ 0.1 ng/ml who is currently without evidence of disease;
3. Relapsed less than 75 days of autologous stem cell transplant;
4. History of allogeneic stem cell transplant;
5. Evidence of central nervous system (CNS) metastasis;
6. Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements;
7. Subjects with a history of moderate or severe psoriasis or with psoriasis associated with systemic symptoms e.g. arthropathy), or with a 1st degree relative with history of psoriasis that required medical intervention;
8. Significant uncontrolled intercurrent illness;
9. Known or tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
10. Active herpes simplex or herpes zoster;
11. Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
12. Known active autoimmune disease will be excluded (For example: Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
13. Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating; Prohibited Therapies and/or Medications
14. Prior treatment with KW-0761;
15. Initiation of treatment with systemic steroids while on study is only permitted for acute and brief complications of underlying disease (e.g., hypercalcemia) or for treatment related side effects;
16. Initiation of treatment with topical steroids while on study is not permitted except to treat an acute rash;
17. Have had anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 4 weeks of screening visit;
18. Subjects on any immunomodulatory drug.