In a single-center phase I/II study reported in the Journal of Clinical Oncology, Shah et al found that adaptive manufactured lentiviral anti-CD20/anti-CD19 (LV20.19) chimeric antigen receptor (CAR) T-cell treatment was highly active in relapsed or refractory mantle cell lymphoma.
Study Details
In this study, 17 patients at Medical College of Wisconsin in whom two lines of therapy failed or who relapsed post-transplantation received a single dose of LV20.19 CAR T cells at 2.5 x 106 cells/kg. The LV20.19 CAR T cells were manufactured on-site via CliniMACS Prodigy using an adaptive 8- to 12-day process to optimize the final CAR product for increased numbers of naive and stem cell memory-like T cells.
Key Findings
Objective responses were observed in all 17 patients (100%), with a complete response in 15 (88%); the phase II efficacy threshold for complete response rate at 90 days was exceeded. At 1 year, median duration of response was not reached, with a 1-year rate of 93%.
Relapse occurred in two patients at 8 and 24 months. At median follow-up of 15.8 months, median progression-free survival was not reached, with a 1-year rate of 80% (95% confidence interval [CI] = 49%–93%), and median overall survival was not reached, with a 1-year rate of 86% (95% CI = 55%–96%).
Cytokine-release syndrome (all grade 1 or 2) occurred in 94% of patients. Immune effector cell–associated neurotoxicity syndrome occurred in three patients (18%) within 28 days and was grade 3 in two patients. Nonrelapse mortality events occurred in three patients, all in the setting of ongoing B-cell aplasia.
The investigators concluded: “…[We] demonstrate that on-site adaptive manufactured LV20.19 CAR T cells are feasible, safe, and efficacious for [relapsed/refractory mantle cell lymphoma] with best [objective response rate] of 100%, a favorable safety profile, and few relapses to date.”
Nirav N. Shah, MD, MS, of the BMT & Cellular Therapy Program, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Miltenyi Biomedicine. For full disclosures of all study authors, visit ascopubs.org.
