The purpose of this study is to determine whether AFM11 is safe and active in the treatment of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL).
CD19 is present on B-cells from earliest recognizable B-lineage cells during development to B-cell blasts and is lost only upon maturation to plasma cells. Expression of CD19 on B-cells at various development stages makes it an ideal target to treat B-cell associated malignancies.The rationale for the use of AFM11 is based on its ability to bind to both malignant cells via its anti-CD19 domain and to T-cells via its anti-CD3 domains. This results in the formation of the "immunological synapse" and the subsequent T-cell activation on leading to killing of malignant cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 4 weeks.
Tufts Medical Center
Boston, Massachusetts, United States
Charles Hospital Prague
Prague, Czechia
University Hospital of the Saarland
Homburg/Saar, Germany
University Hospital
Kiel, Germany
Number of participants with serious and non-serious adverse events as a measure of safety and tolerability of AFM11.
Measure occurence of adverse events until the Final Study Visit and monitor laboratory safety parameters at least once weekly. Assess immunogenicity of AFM11 at end of treatment cycle.
Time frame: From administration of the first dose of study drug and through 30 days after the last dose, up to 8 weeks.
Maximum Tolerated Dose (MTD) of AFM11.
Time frame: up to 8 weeks
Pharmacokinetic profile of AFM11 and immunological markers of AFM11 activity.
Concentration of AFM11 in blood samples will measured at different time points during the 4 weeks of treatment and 30 days thereafter to determine concentration-time profiles. Immunological markers like lymphocytes and cytokine levels in serum will be measured at different time points during the 4 weeks of treatment and 30 days thereafter to assess the level of activity resulting from administration of AFM11.
Time frame: Prior to initial dose on Day 1 and at multiple time points during the 4 weeks of treatment until up to 30 days after the last dose.
Tumor Response.
Measure tumor size and activity in FDG-PET and CT-scans.
Time frame: Baseline and at week 6.
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University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Germany
University Hospital
Ulm, Germany
University Hospital
Würzburg, Germany
SP ZOZ University Hospital Krakow
Krakow, Poland
MTZ Clinical Research
Warsaw, Poland