Nirav N. Shah, MD, associate professor, Medical College of Wisconsin, discusses the dosing of tandem receptor CAR T-cell therapy in B-cell malignancies.
Nirav N. Shah, MD, associate professor, Medical College of Wisconsin, discusses the dosing of tandem receptor CAR T-cell therapy in B-cell malignancies.
A single-arm, open-label, phase 1 expansion trial (NCT03019055) evaluated the safety and feasibility of anti-CD20 and anti-CD19 CAR T-cell therapy (CAR-20/19-T) in patients with relapsed/refractory CD19/CD20-positive B-cell malignancies, Shah says.
Patients received a low dose of 2.5 x 106 cells/kg of the investigational product in a single infusion, says Shah. With this dose, minimal toxicities were observed. For example, some reports of cytokine release syndrome and neurotoxicity were noted; however, the numbers were low. Notably, the first 6 patients on the study received the target dose of CAR-20/19-T and achieved high response rates, Shah adds.
Moreover, this trial was unique because the CAR T-cell therapy products were manufactured in-house with the CliniMACS Prodigy device, which allowed fresh CAR T cells to be collected from patients. The therapy was then administered without mandated cryopreservation, Shah concludes.