Tanya Zhidkova, PhD’s Post

View profile for Tanya Zhidkova, PhD, graphic

MBA Сandidate at Boston College | Innovation Lead at Novo Nordisk

While the FDA requests a boxed warning on all commercial autological CAR-T, allogeneic CD19-specific CAR-NK cells have shown a high safety profile and promising efficacy in phase 1/2 trials for patients with B cell malignancies. Researchers at The University of Texas M.D. Anderson Cancer Center have successfully isolated and expanded NK cells from a donor cord blood unit, arming them with an anti-CD19 CAR. Notably, none of the 37 participants in the NCT03056339 clinical trial developed neurotoxicity or graft-versus-host disease, even at maximum tested doses (10 mln cells/kg and a flat dose of 800 mln cells). The day 30 and day 100 overall response rates were both 49%, with 1-year overall survival and progression-free survival rates at 68% and 32%, respectively. Additionally, it was found that the characteristics of the donors’ cord blood units can predict patient outcomes, which could complicate replication and enhance IP protection. These findings offer the potential for safer option for patients with relapsed/refractory CD19-positive B cell malignancies, with significant advantages in logistics, manufacturing, and quality control. Marin, D., Li, Y., Basar, R. et al. Safety, efficacy and determinants of response of allogeneic CD19-specific CAR-NK cells in CD19+ B cell tumors: a phase 1/2 trial. Nat Med (2024). https://lnkd.in/dzP3DS3y     FDA January Safety and Availability Communications: https://lnkd.in/drbe-9GV #BioTechnology #CellTherapy #CARTCellTherapy #CARNKCellTherapy

Safety, efficacy and determinants of response of allogeneic CD19-specific CAR-NK cells in CD19+ B cell tumors: a phase 1/2 trial - Nature Medicine

Safety, efficacy and determinants of response of allogeneic CD19-specific CAR-NK cells in CD19+ B cell tumors: a phase 1/2 trial - Nature Medicine

nature.com

To view or add a comment, sign in

Explore topics