Safety Study to Assess AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02106091|
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed B-Cell Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma||Drug: AFM11||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacodynamically-guided, Dose-escalation, Phase I Study to Assess the Safety of AFM11 (Recombinant Antibody Construct Against Human CD19 and CD3) in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL.|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||September 2018|
IV (intravenous) infusion, dose escalation
Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 4 weeks.
- Number of participants with serious and non-serious adverse events as a measure of safety and tolerability of AFM11. [ Time Frame: From administration of the first dose of study drug and through 30 days after the last dose, up to 8 weeks. ]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.
- Maximum Tolerated Dose (MTD) of AFM11. [ Time Frame: up to 8 weeks ]
- Pharmacokinetic profile of AFM11 and immunological markers of AFM11 activity. [ 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. ]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.
- Tumor Response. [ Time Frame: Baseline and at week 6. ]Measure tumor size and activity in FDG-PET and CT-scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106091
|Contact: Kim Prier||+49 6221 65307 ext firstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Charles Hospital Prague||Recruiting|
|Prague, Czechia, 11636|
|University Hospital of the Saarland||Recruiting|
|Homburg/Saar, Germany, 66421|
|Kiel, Germany, 24105|
|University Medical Center of the Johannes Gutenberg University Mainz||Recruiting|
|Mainz, Germany, 55131|
|Ulm, Germany, 89081|
|Wuerzburg, Germany, 97080|
|SP ZOZ University Hospital Krakow||Recruiting|
|Krakow, Poland, 31501|
|MTZ Clinical Research||Recruiting|
|Warsaw, Poland, 02106|