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Clinical Trial 19962

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03912831

Phase: Phase I
Prinicipal Investigator: Kedar Kirtane

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Overview

Study Title

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

Summary

Study KITE-439 is a Phase 1 study evaluating the safety and efficacy of KITE-439 in subjects who are HLA-A*02:01+ and have HPV16+ relapsed/refractory cancers. The trial is separated into 2 phases: Phase 1A and Phase 1B.

Objective

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, as measured by objective response rate (ORR). Secondary objectives include assessing the safety of KITE-439 and additional efficacy endpoints.

Treatments

Therapies

Medications

KITE-439 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Advanced cancer defined as relapsed or refractory disease after at least 1 line of therapy that included systemic chemotherapy and that is not amenable to definitive locoregional therapy
  • HPV16+ tumor as confirmed by the central laboratory
  • HLA type is HLA-A*02:01+ per local assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

  • Exclusion Criteria

  • Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management. Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor
  • Primary immunodeficiency
  • History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment. Immune-mediated toxicity due to immunotherapy for treatment of cancer is not exclusionary if a healthcare professional confirms complete resolution while off systemic immunosuppressive/systemic disease modifying agents with no evidence of recurrence for at least 6 months prior to enrollment, and treatment with systemic immunosuppressive / systemic disease modifying agents, with the exception of physiologic steroid replacement, is not required during study participation.
  • Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing
  • Other protocol defined Inclusion/Exclusion criteria may apply.

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