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IV (intravenous) infusion, dose escalation

Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.

AFM 13

Andreas Engert, Professor

Anas Younes, Professor

Max S Topp, Professor

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.

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

Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.

To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered.

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.

To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Assess AFM13 in Patients With Hodgkin Lymphoma	NCT01221571	Hodgkin Lymphom...	AFM 13	18 Years -	Affimed GmbH
A Study to Assess AFM13 in Patients With Hodgkin Lymphoma	NCT01221571	Hodgkin Lymphom...	AFM 13	18 Years -	Affimed GmbH

Spots Global Cancer Trial Database for afm 13

Every month we try and update this database with for afm 13 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for afm 13

Every month we try and update this database with for afm 13 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for afm 13 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.