Manali Kamdar, MD, MBBS, discusses the background on a phase 1 clinical trial testing a novel anti-CD19 chimeric antigen receptor T-cell product in adults with relapsed/refractory B-cell non-Hodgkin’s lymphoma.
Manali Kamdar, MD, MBBS, assistant professor of medicine and clinical director of lymphoma services at the University of Colorado Hospital, discusses the background on a phase 1 clinical trial testing a novel anti-CD19 chimeric antigen receptor (CAR) T-cell product in adults with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma.
According to Kamdar, genetically engineered CAR T cells have previously exhibited promising results in regard to efficacy against chemotherapy refractory CD19 expressing B-cell malignancies.
During her presentation at the AACR Annual Meeting 2022, Kamdar further explained how the expected timeline from manufacturing to delivery of anti-CD19 CAR T-cell products could be simplified from 3-4 weeks to 2 weeks. By shortening the process, patients with R/R B-cell non-Hodgkin’s lymphoma could have the potential of decreasing the amount of interim therapy and potential morbidity.
0:08 | Genetically engineered CAR T-cell therapies have exhibited distinct efficacy against chemotherapy refractory CD19 expressing B-cell non Hodgkin lymphomas. Our phase 1 clinical trial tests a novel anti-CD19 CAR T-cell product in adults with relapsed/refractory large B-cell lymphoma. It is also important to underscore that the existing CAR T-cell therapy manufacturing takes about 3 to 4 weeks and we typically have to outsource that to the companies that have the approval for the CAR T constructs.
0:48 | In order to simplify the process of CAR T-cell manufacturing, the CliniMax prodigy by Miltenyi was used in this phase 1 clinical trial. The prodigy is basically a self contained, closed, largely automated device that obviates the need for human involvement in numerous steps, thus reducing human resource utilization and the risk of cell contamination.
1:11 | The study investigated a CD19 directed CAR T-cell product that was produced on site by GBF using the prodigy. The idea was that the expected timeline from manufacturing to delivery could be shortened to as less as 2 weeks or even under, thus hopefully decreasing the amount of interim therapy as well as potential morbidity.