Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers

Phase 1 Terminated 8 enrolled Gilead Sciences

Non-randomizedSequentialOpen-labelTreatment

Summary

This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human leukocyte antigen (HLA)-A\*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+ cancers.

Timeline

Start: 2019-04-30
Primary completion: 2022-02-18
Completion: 2022-02-18

Outcome

Outcome not reported

Stopped: “Development program terminated”

Publications

Results Kirtane K, Niu J, Blumenschein G, Massarelli E, Hanna GJ, Lee S, Bishop MR, Konecny GE, Mao D, Zheng Y, Rodriguez K, Kim JJ, Williams C, Schweitzer C, Adhikary S, Jung AS, Klebanoff CA. A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial). Front Oncol. 2026 May 21;16:1809354. doi: 10.3389/fonc.2026.1809354. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KITE-439	Cell therapy	1e+06 cells/kg	—
Subject	KITE-439	Cell therapy	3e+06 cells/kg	—
Subject	KITE-439	Cell therapy	1e+07 cells/kg	—
Subject	KITE-439	Cell therapy	3e+07 cells/kg	—
Subject	KITE-439	Cell therapy	1e+08 cells/kg	—
Background	Cyclophosphamide	Other / unclassified	30 mg/kg	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	aldesleukin	Protein / enzyme biologic	250000 iu/kg	Subcutaneous