NCT03912831

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

A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer

Interventions

Type	Name	Description
DRUG	KITE-439	A single infusion of E7 TCR T cells (KITE-439).
DRUG	Cyclophosphamide	Administered intravenously.
DRUG	Fludarabine	Administered intravenously.
DRUG	Interleukin-2	Administered subcutaneously.

Timeline

• Start date: 2019-04-30
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2019-04-11
• Last updated: 2023-12-26
• Results posted: 2023-12-26

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study