Non Hodgkin's Lymphoma Refractory/Relapsed Clinical Trial
Official title:
Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma.
Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.
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 only and in combination with rituximab and N 803 in subjects with R/R NHL. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities. Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4 week cycle of the CD19 t haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab (cohort A) or in combination with rituximab and N-803 (cohort B). Following a second 1-week rest period, subjects will receive up to 4 repeated 4 week cycles of CD19 t haNK in combination with rituximab (cohort A) or in combination with rituximab and N 803 (cohort B) without lymphodepleting chemotherapy. ;