Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma

Phase 1 Terminated 15 enrolled Kite, A Gilead Company Pfizer · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objectives of this study are: Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma

Timeline

Start: 2018-11-20
Primary completion: 2021-05-07
Completion: 2022-12-15

Publications

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axicabtagene Ciloleucel	Cell therapy	2e+06 cells/kg	Intravenous
Subject	Axicabtagene Ciloleucel	Cell therapy	2e+08 cells	Intravenous
Subject	Utomilumab	Monoclonal antibody	10 mg	Intravenous
Subject	Utomilumab	Monoclonal antibody	30 mg	Intravenous
Subject	Utomilumab	Monoclonal antibody	100 mg	Intravenous
Subject	Utomilumab	Monoclonal antibody	200 mg	Intravenous
Subject	Utomilumab	Monoclonal antibody	400 mg	Intravenous
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma

Summary

Timeline

Publications

Drugs

Indications