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A Multicenter, Phase 1, Open-Label, Dose-Escalation and Expansion Study Of TNB-486, A Bispecific Antibody, In Subjects With Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma

Protocol No
Principal Investigator
Sumana Devata
The study drug, TNB-486, is a ‘bispecific’ antibody. An antibody is a Y shaped protein used by your body’s immune system to identify and destroy natural foreign objects such as bacteria, viruses and proteins. A bispecific antibody is an antibody that interacts with two different molecules in your body. In the case of TNB-486, one molecule is called CD19 that is found on your lymphoma cells. The second molecule is called CD3 and is present on your T-cells. A T-cell is a type of white blood cell that plays an important role in the immune system. T-cells are like soldiers that search out and destroy virus infected cells, foreign cells and cancer cells. When CD3 is engaged on a T-cell, it turns the T-cell on and makes it kill whatever cell triggered the activation. Because TNB-486 sticks very strongly to your lymphoma cells, nearby T-cells should specifically attack your tumor (lymphoma) cells.
This is a Phase 1, First-in-Human clinical trial, meaning that it is the first study where TNB-486 will be given to humans. This study is open-label, meaning that everyone on the study will receive study drug, at various doses.
The purpose of the Study is:
• To find the highest dose of the study drug that can be given without causing severe side effects.
• To identify side effects of the study drug at different doses.
• To gather early information about how well the study drug treats lymphoma
• To measure the amount of the study drug in the blood at different timepoints after study drug administration, at different doses.
• To evaluate biomarkers in your blood or other parts of your body. A biomarker is a substance in your blood or other location that may tell us something about your disease, indicate how your disease is progressing, or provide information about how effective a study drug is.
Participating Institutions
Froedtert Hospital