Rothe, Achim, Sasse, Stephanie, Topp, Max S., Eichenauer, Dennis A., Hummel, Horst, Reiners, Katrin S., Dietlein, Markus, Kuhnert, Georg, Kessler, Joerg, Buerkle, Carolin, Ravic, Miroslav, Knackmuss, Stefan, Marschner, Jens-Peter, von Strandmann, Elke Pogge, Borchmann, Peter and Engert, Andreas (2015). A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma. Blood, 125 (26). S. 4024 - 4032. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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Abstract

AFM13 is a bispecific, tetravalent chimeric antibody construct (TandAb) designed for the treatment of CD30-expressing malignancies. AFM13 recruits natural killer (NK) cells via binding to CD16A as immune effector cells. In this phase 1 dose-escalation study, 28 patients with heavily pretreated relapsed or refractory Hodgkin lymphoma received AFM13 at doses of 0.01 to 7 mg/kg body weight. Primary objectives were safety and tolerability. Secondary objectives included pharmacokinetics, antitumor activity, and pharmacodynamics. Adverse events were generally mild to moderate. The maximum tolerated dose was not reached. Pharmacokinetics assessment revealed a half-life of up to 19 hours. Three of 26 evaluable patients achieved partial remission (11.5%) and 13 patients achieved stable disease (50%), with an overall disease control rate of 61.5%. AFM13 was also active in brentuximab vedotin-refractory patients. In 13 patients who received doses of >= 1.5 mg/kg AFM13, the overall response rate was 23% and the disease control rate was 77%. AFM13 treatment resulted in a significant NK-cell activation and a decrease of soluble CD30 in peripheral blood. In conclusion, AFM13 represents a well-tolerated, safe, and active targeted immunotherapy of Hodgkin lymphoma. A phase 2 study is currently planned to optimize the dosing schedule in order to further improve the therapeutic efficacy. This phase 1 study was registered at www.clinicaltrials.gov as #NCT01221571.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Rothe, AchimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sasse, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topp, Max S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichenauer, Dennis A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hummel, HorstUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reiners, Katrin S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dietlein, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhnert, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kessler, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buerkle, CarolinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ravic, MiroslavUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Knackmuss, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marschner, Jens-PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Strandmann, Elke PoggeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engert, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-400838
DOI: 10.1182/blood-2014-12-614636
Journal or Publication Title: Blood
Volume: 125
Number: 26
Page Range: S. 4024 - 4032
Date: 2015
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 1528-0020
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ACUTE LYMPHOBLASTIC-LEUKEMIA; BRENTUXIMAB VEDOTIN; CANCER-IMMUNOTHERAPY; DISEASE; THERAPY; CHEMOTHERAPY; CELLS; BLINATUMOMAB; LENALIDOMIDE; MULTICENTERMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/40083

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