CClinicalTrials.gg
CompletedNCT01221571Updated Jun 26, 2013

A Study to Assess AFM13 in Patients With Hodgkin Lymphoma

A Phase 1 interventional study of AFM 13 in Hodgkin Lymphoma, sponsored by Affimed GmbH. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by Affimed GmbH · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hodgkin Lymphoma

Keywords

  • Phase I
  • Dose escalation
  • AFM 13
  • Natural killer cell
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 28 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Affimed GmbH is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.
  2. Age ≥18 years.
  3. Both genders.
  4. Patients who have relapsed or are refractory after at least two prior potentially curative therapies including autologous stem cell transplantation (ASCT). Patients with a progressive disease after the first-line therapy who are ineligible for, or refused to receive high dose chemotherapy and/or ASCT for the second-line therapy, or any other established curative therapy, are also eligible.
  5. Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.
  6. Patients who received ASCT should have fully recovered prior to study entry.
  7. Eastern Cooperative Oncology Group (ECOG) status of ≤2.
  8. Laboratory data:

    1. Platelet count >75,000/mm3;
    2. Hemoglobin >9.0 g/dL (may be maintained by transfusion);
    3. Absolute neutrophil count >1500/mm3;
    4. ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)\<2.5 times the upper limit of normal (ULN);
    5. Total bilirubin \<1.5 times ULN;
    6. Creatinine \<1.5 mg/dL.
  9. Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use medically effective contraception during the treatment period and up to 60 days after the last AFM13 administration. The patient must agree to sign his or her consent on this particular inclusion criterion.
  10. Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  11. Be willing and able to comply with the study protocol for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Any significant diseases (other than HL (Hodgkin Lymphoma)) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participating in the study.
  2. History or clinical evidence of central nervous system (CNS) HL.
  3. Allogeneic SCT.
  4. Major surgery within 4 weeks prior to study entry.
  5. Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  6. Known history of another primary malignancy that has not been in remission for at least 5 years. Non-concurrent non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.
  7. Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to study entry.
  8. Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
  9. History of significant chronic or recurrent infections requiring treatment.
  10. Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately preceding enrollment.
  11. Pregnant or breast-feeding.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    AFM13

    IV (intravenous) infusion, dose escalation

    Drug: AFM 13

Interventions

  • DrugAFM 13

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13

    Time frame: Length of study

  2. 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

  3. 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

  4. To assess the immunogenicity of AFM13.

    Time frame: length of study

  5. 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

07

Study locations

3 sites
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030-2374, United States
  • University Hosptial Cologne
    Koln, Köln 50924 Köln, Germany
  • University Hospital Würzburg
    Würzburg, 97080, Germany
08

References and documents

Publications

  • Rothe A, Sasse S, Topp MS, Eichenauer DA, Hummel H, Reiners KS, Dietlein M, Kuhnert G, Kessler J, Buerkle C, Ravic M, Knackmuss S, Marschner JP, Pogge von Strandmann E, Borchmann P, Engert A. A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2015 Jun 25;125(26):4024-31. doi: 10.1182/blood-2014-12-614636. Epub 2015 Apr 17. PubMed 25887777 ↗
  • Reiners KS, Kessler J, Sauer M, Rothe A, Hansen HP, Reusch U, Hucke C, Kohl U, Durkop H, Engert A, von Strandmann EP. Rescue of impaired NK cell activity in hodgkin lymphoma with bispecific antibodies in vitro and in patients. Mol Ther. 2013 Apr;21(4):895-903. doi: 10.1038/mt.2013.14. Epub 2013 Mar 5. PubMed 23459515 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01221571
Lead sponsor
Affimed GmbH
Responsible party
Sponsor
First posted
Oct 15, 2010
Start date
Oct 2010
Primary completion
May 2013
Completion
Jun 2013
Last update
Jun 26, 2013

Study contacts

Andreas Engert, Professor
principal investigator · University Hospital Cologne, Germany
Anas Younes, Professor
principal investigator · MD Anderson Cancer Center, Houston, Texas
Max S Topp, Professor
principal investigator · University Hospital Würzburg, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion