Hodgkin Lymphoma Clinical Trial
Official title:
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
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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