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Nirav Shah, MD, MCW, discusses the safety profile of an anti-CD20/anti-CD19 CAR T-cell therapy under investigation in the treatment of patients with non-Hodgkin lymphoma.
Nirav Shah, MD, MCW, an associate professor at the Medical College of Wisconsin, discusses the safety profile of an anti-CD20/anti-CD19 CAR T-cell therapy under investigation in the treatment of patients with non-Hodgkin lymphoma.
The safety of the CAR T-cell product was examined in a phase 1 study that launched in 2017, according to Shah. When the trial began, it was one of the first studies to examine a dual-targeted agent in this patient population. Because of this, it was very important to demonstrate the product's safety, Shah explains, as there are concerns that targeting more than 1 B-cell antigen could result in increased toxicities like cytokine release syndrome (CRS) and neurotoxicity.
The CAR T-cell therapy was found to be safe, Shah says. The incidence of CRS and neurotoxicity were low and no patients died as a result of undergoing treatment. Additionally, the adverse effects reported in patients were found to be reversible. Investigators were able to identify a safe and efficacious dose of 2.5 × 106 cells/kg that will be further evaluated in a larger phase 2 study. With this effort, investigators hope to further demonstrate the efficacy of the product.
Although the agent has already shown a promising response signal, the phase 1 study was comprised of a smaller patient population, Shah explains. The phase 2 study will offer the opportunity to evaluate the recommended phase 2 dose of the agent in a larger patient population, Shah concludes.