Ignite Creation Date:
2024-05-05 @ 10:57 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01221571
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2010-10-05
Brief Title:
A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
Sponsor:
Affimed GmbH
Organization:
Affimed GmbH
Study Overview
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 andor Relapsed Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 andor 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 eg 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
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 andor 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-019232-13 | EUDRACT_NUMBER | None | None |