A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell 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: Open
Phase: II
Principal Investigator: Lunning, Matthew
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04792489?term=NCT04792489&rank=1
Summary
Primary objective:
To determine the efficacy of MB-CART2019.1 cells administered following a conditioning lymphodepletion regimen in diffuse large B cell lymphoma (DLBCL) subjects who failed at least two lines of therapy as measured by ORR at one month
Secondary objectives:
To describe the outcome of subjects up to two years after receiving MB-CART2019.1 cells as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
To correlate the in vivo persistence of MB-CART2019.1 with clinical efficacy, incidence of cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
To characterize the types and level of serum cytokines associated MB-CART2019.1 infusion
To explore the relationship between antigen expression and disease progression and relapse after MB-CART2019.1 treatment
Exploratory objectives:
To investigate minimal residual disease (MRD)
To analyze pharmacodynamic changes in blood cells