Clinical Trials - Cancer Research Institute (CRI)

Cutaneous T-Cell Lymphoma

071163 - A Phase I/II study of A-dmDT390-bisFv(UCHT1) Fusion Protein in Patients with Cutaneous T-Cell Lymphoma

Study Overview

This is a Phase I/II, open-label, dose-escalation, multidose study of A-dmDT390-bisFv (UCHT1) Fusion Protein. A-dmDT390-bisFv (UCHT1) is an immunotoxin targeting the CD3 receptor found on malignant T-cells. It is anticipated that approximately 30 patients will be enrolled in this study over two years.

Patients will receive full supportive care including transfusions of irradiated washed blood and blood products, antibiotics, antiemetics, etc, when appropriate. However, other anti-neoplastic drugs or hematopoietic growth factors (e.g., erythropoietin, interleukin-11, G-CSF and GM-CSF) are not allowed. Patients will be hospitalized for five days and will be monitored with labwork and/or clinic visits two to three times weekly for the first 30 days after completion of a four day administration cycle of A-dmDT390-bisFv (UCHT1). Patients will then have a follow-up visits on day 30. Patients with partial or complete remissions will have another follow-up visit on day 60, then every three months for one year, followed by annual visits to assess duration of the response.

Inclusion Criteria:

• At least 18 years old.
• Diagnosis of T-cell lymphoma.
• Must be relapsed or refractory after receiving at least one prior topical or conventional therapy.
• Patients must have CD3 on tumor cells.
• Adequate cardiac function.
• Adequate liver function.
• Adequate kidney function.
• No serious concurrent medical conditions, CNS disease, uncontrolled infections, heart attack in the last six months, or disseminated intravascular coagulopathy (DIC).
• Willing to use an approved form of birth control while on study and for two weeks after completion.

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