The aim 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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University Hosptial Cologne
Cologne, Köln, Germany
University Hospital Würzburg
Würzburg, Germany
To determine the safety and tolerability of AFM13 monotherapy.
Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
Time frame: Length of Study
To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13
Time frame: Length of study
To define the pharmacokinetic profile of AFM13.
To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered.
Time frame: Length of study
To analyse immunological markers of activity
ADCC, NK cell, Complement and Cytokine levels in the serum will be measured at different time points to assess the level of activity resulting from administration of AFM13.
Time frame: Length of study
To assess the immunogenicity of AFM13.
Time frame: length of study
To assess the activity of AFM13
To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.
Time frame: length of study
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