Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.

For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.

Individuals may be eligible for this study if they are 18 years of age or older and:

• Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy.
• At least 30% of tumor cells must be CD2 positive.
• Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work).
• At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia).
• Have no prior treatment with MEDI-507.