Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

Inclusion Criteria:

• A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
• Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
• Signed informed consent

Exclusion Criteria:

• Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
• Prior treatment with Campath (alemtuzumab)
• Prior treatment with more than three regimens of single agent chemotherapy
• Prior treatment with pentostatin within 6 months
• Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
• Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
• Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease
• Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
• Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
• Known or suspected positive serology for HIV
• Known or suspected positive serology for hepatitis B or C
• Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
• Prior treatment with anti-CD4 monoclonal antibodies
• Breast feeding women or women with a positive pregnancy test at Visit 1
• Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period