Dr. Shah on Dosing 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 rate​s, 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.