Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
B-cell non-Hodgkin lymphoid malignancies (NHLs) are defined by clonal populations of B- lymphocytes. JNJ-80948543 is a T-cell redirecting tri-specific antibody that recognizes the cluster of differentiation 3 (CD3) antigen on T lymphocytes and CD79b, and CD20 surface antigens on mature healthy and malignant B- lymphocytes. The study will be conducted in 2 parts: Part A (dose Escalation) and part B (Cohort Expansion). Each of the 2 parts of this study is divided into 3 periods, a screening phase, a treatment phase and a post-treatment follow-up phase. The total duration of the study will be up to 2 year 5 months. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy, physical examinations. Safety will be monitored throughout the study. ;
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