Non-Hodgkin Lymphoma Refractory/ Relapsed Clinical Trial
Official title:
Open-Label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With Rituximab in Subjects With Selected CD19+ and CD20+ Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).
This is a phase 1, first-in-human (FIH), open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of CD19 t haNK in combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities. Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen. Following a 1-week safety pause, subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab. Subjects will then undergo the first tumor assessment. Subjects with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3 week cycles of CD19 t haNK in combination with rituximab. ;