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Saurabh Dahiya, MD, FACP, discusses safety and efficacy data from a study of the CAR T-cell therapy KITE-363 in relapsed/refractory B-cell lymphoma.
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“We did not observe any DLTs, and as such, we were able to reach the highest [planned] dose level.”
Saurabh Dahiya, MD, FACP, an associate professor of medicine at Stanford University School of Medicine; as well as clinical director of Cancer Cell Therapy in the Division of Blood and Marrow Transplantation and Cell Therapy at Stanford Medicine, discussed findings from a phase 1 study (NCT04989803)investigating the CD19/CD20-directed CAR T-cell therapy KITE-363 in patients with relapsed/refractory B-cell lymphoma.
This trial enrolled 41 adult patients with large B-cell lymphoma (LBCL), indolent non-Hodgkin lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma, or mediastinal gray zone lymphoma who had relapsed on or were refractory to at least 2 prior lines of therapy. Notably, patients with LBCL were permitted to enroll if they had primary refractory disease after at least 1 line of therapy.
The primary end point of this study was the assessment of dose-limiting toxicities (DLTs). Among all treated patients (n = 37), no DLTs were observed during the evaluation period, which allowed for dose escalation to the highest planned dose level, Dahiya said. At the maximum dose level of 2 x 106 CAR T cells/kg, in patients with primary-refractory LBCL (n = 15), no grade 3, 4, or 5 cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome was reported, demonstrating the agent’s favorable safety profile, according to Dahiya.
Among patients with LBCL, treatment at the highest dose level in those who were CAR T-cell therapy naive (n = 23) resulted in an overall response rate of 87%, with a complete remission (CR) rate of 78%. Furthermore, the median duration of CR in CAR T-cell therapy–naive patients was not reached (95% CI, 5.2 months-not evaluable), and the estimated 6-month CR rate was 71.4% (95% CI, 44.3%-87.0%).
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