A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13 (Recombinant Antibody Construct Against Human CD30 and CD16A) in Patients With Refractory and/or Relapsed Hodgkin Lymphoma
Study Objectives:
The overall objective of this study is to determine the safety, tolerability,
pharmacokinetics and activity of single cycles of AFM13 in patients with CD30 positive
refractory and/or relapsed Hodgkin lymphoma.
Objectives:
1. To determine the safety and tolerability of increasing doses of single cycles of AFM13
monotherapy.
2. To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of
AFM13; whichever is reached first.
3. To define the pharmacokinetic profile of AFM13.
4. To analyse immunological markers e.g. ADCC (Antibody dependent cell mediated
cytotoxicity), NK (Natural killer) cell activity, complement activation and depletion,
and cytokine release.
5. To assess the immunogenicity of AFM13.
6. To assess the activity of AFM13.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of AFM13 monotherapy.
Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
Length of Study
Yes
Andreas Engert, Professor
Principal Investigator
University Hospital Cologne, Germany
United States: Food and Drug Administration
AFM13-101
NCT01221571
October 2010
June 2013
Name | Location |
---|---|
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |