A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients with Surface CD3+ Malignant T Cell Diseases

Diseases and Conditions Researched

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.

Participation Guidelines

Age: 18 and older
Gender: Both

Click here for detailed participation information for this trial.

Sponsor: Angimmune
Dates:
Last Updated:
Study HIC#: 1207010601