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

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