A Phase I/II Multi-Center Study Evaluating the Safety and Efficacy of LYL314, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Lymphoma/CLL (ONC)
Current Status: Not open
Phase: I/II (Cancer Control)
Principal Investigator: Lunning, Matthew
Contact Information:
Linda Chee
linda.chee@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05826535?term=nct05826535&rank=1#participation-criteria
Summary
Phase I
Primary: To evaluate the safety and tolerability of a single dose of LYL314 administered as a single agent; To determine the RP2D for LYL314
Secondary: To evaluate the efficacy of LYL314; To evaluate the feasibility of treatment with LYL314; To evaluate the pharmacokinetics of LYL314 when administered as a single agent
Exploratory: To characterize biomarkers associated with response; To estimate the incidence of anti-CAR antibodies;
To evaluate the efficacy of LYL314 retreatment
Phase II (Cohort 1 Expansion)
Primary: To estimate the efficacy of LYL314, as measured by ORR
Secondary: To estimate the efficacy of LYL314; To evaluate the safety and tolerability of a single dose of LYL314 administered as a single agent; To evaluate the pharmacokinetics of LYL314 when administered as a single agent
Exploratory: To characterize biomarkers associated with response; To estimate the incidence of anti-CAR antibodies;
To evaluate the efficacy of LYL314 retreatment