Study Title

A Phase 2, Single-Arm, Open-Label Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Summary

The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.

Objective

Primary: To evaluate the efficacy of itacitinib as a preventative treatment for CRS associated with IEC therapy Secondary: -To evaluate the proportion of participants with ICANS regardless of CRS, after IEC therapy -To evaluate the onset and episode of ICANS using the ICANS Consensus Grading, regardless of CRS, by Day 18 -To evaluate the duration of all grades of CRS, by Day 28 -To evaluate the proportion of participants who develop any grade of CRS within 48 hours after IEC therapy -To evaluate the proportion of participants who develop greater than/equal to Grade 2 CRS by Day 28 of administration after first IEC therapy -To characterize the safety of icacitinib, before and after IEC therapy, excluding CRS and ICANS -To evaluate the number of and length of hospital admissions for CRS and ICANS Exploratory -To evaluate ORR and MRD with IEC therapy in combination with itacitinib -To evaluate tocilizumab treatment necessity for participants on itacitinib against historical data -To evaluate ferritin, CRP, IL-6, IFN-γ, IL-1 and NO levels after IEC therapy -to evaluate cytokine and biomarker profiles associated with and/or predictive of CRS and/or ICANS after IEC therapy -To evaluate PK of itacitinib in participants received IEC therapy