A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients with Surface CD3+ Malignant T Cell Diseases
Cancer | Non-Hodgkin's Lymphoma
What is the purpose of this trial?
- Determine the maximal tolerated dose (MTD) of A-dmDT390-bisFv(UCHT1) fusion protein as a bolus infusion on days 1-4 in patients with CD3+ T-cell malignant diseases.
- Define the dose-limiting toxicities (DLT) of this A-dmDT390-bisFv(UCHT1) regimen in patients with CD3+ T-cell malignant diseases
- Measure the pharmacokinetics, and immune responses to this course of bolus infusions of A-dmDT390-bisFv(UCHT1) fusion protein.
- Evaluate responses and correlate with the in vitro sensitivity of patient malignant T-cells to A-dmDT390-bisFv(UCHT1).
- Determine the extent and kinetics of resting and malignant T-cell depletion and repopulation in the treatment groups by flow cytometry of samples obtained from blood and marrow aspirations.
- 18 and older
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