NCT01221571

A Study to Assess AFM13 in Patients With Hodgkin Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Affimed GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	AFM 13	Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2010-10-15
• Last updated: 2013-06-26

Locations

3 sites across 2 countries: United States, Germany