A Study to Assess AFM13 in Patients With Hodgkin Lymphoma

NCT01221571 | Completed Phase 1 DMC

• 2 other identifiers: AFM13-1012010-019232-13
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 3

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 and/or relapsed Hodgkin lymphoma.

Conditions

Hodgkin Lymphoma

Keywords

Phase I; Dose escalation; AFM 13; Natural killer cell

Outcome Measures

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.

  Length of Study

Secondary Outcomes (5)

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

  Length of study

• To define the pharmacokinetic profile of AFM13.

  Length of study

• To analyse immunological markers of activity

  Length of study

• To assess the immunogenicity of AFM13.

  length of study

• To assess the activity of AFM13

  length of study

Study Arms (1)

AFM13

EXPERIMENTAL

IV (intravenous) infusion, dose escalation

Drug: AFM 13

Interventions

AFM 13 DRUG

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

AFM13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.
• Age ≥18 years.
• Both genders.
• 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.
• Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.
• Patients who received ASCT should have fully recovered prior to study entry.
• Eastern Cooperative Oncology Group (ECOG) status of ≤2.
• Laboratory data:
• Platelet count \>75,000/mm3;
• Hemoglobin \>9.0 g/dL (may be maintained by transfusion);
• Absolute neutrophil count \>1500/mm3;
• ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)\<2.5 times the upper limit of normal (ULN);
• Total bilirubin \<1.5 times ULN;
• Creatinine \<1.5 mg/dL.
• 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.

You may not qualify if:

• 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.
• History or clinical evidence of central nervous system (CNS) HL.
• Allogeneic SCT.
• Major surgery within 4 weeks prior to study entry.
• Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
• 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.
• Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to study entry.
• Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
• History of significant chronic or recurrent infections requiring treatment.
• Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately preceding enrollment.
• Pregnant or breast-feeding.

Sponsors & Collaborators

• Affimed GmbH: lead

Study Sites (3)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-2374, United States

Location

University Hosptial Cologne

Cologne, Köln, 50924 Köln, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

Related Publications (2)

• 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.

  PMID: 25887777 DERIVED

• 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.

  PMID: 23459515 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andreas Engert, Professor

  University Hospital Cologne, Germany

  PRINCIPAL INVESTIGATOR

• Anas Younes, Professor

  MD Anderson Cancer Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

• Max S Topp, Professor

  University Hospital Würzburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2011-02

Locations

US (1); DE (2)