A 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 for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematologic malignancies.

Timeline

Start

2020-02-07

Primary completion

2023-02-23

Completion

2023-08-22

Outcome

Met primary endpoint

paper By day 14, grade ≥2 CRS occurred in fewer patients on 200 mg twice daily itacitinib (17.4%) than on placebo (56.5%; P = .003). PMID 40090005 ↗

Publications

• Frigault MJ, Maziarz RT, Park JH, Lazaryan A, Shah NN, Svoboda J, Lekakis L, Reshef R, Phillips CL, Burke L, Lei J, Pratta M, Morariu-Zamfir R, DiPersio JF. Itacitinib for the prevention of IEC therapy-associated CRS: results from the 2-part phase 2 INCB 39110-211 study. Blood. 2025 Jul 24;146(4):422-436. doi: 10.1182/blood.2024026586.
• Huarte E, O'Connor RS, Peel MT, Nunez-Cruz S, Leferovich J, Juvekar A, Yang YO, Truong L, Huang T, Naim A, Milone MC, Smith PA. Itacitinib (INCB039110), a JAK1 Inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-cell Therapy. Clin Cancer Res. 2020 Dec 1;26(23):6299-6309. doi: 10.1158/1078-0432.CCR-20-1739. Epub 2020 Sep 30.

Drugs

Indications