Clinical Trials /

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

NCT03912831

Description:

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 human leukocyte antigen (HLA)-A*02:01+ adults with relapsed/refractory human papillomavirus (HPV)16+ cancers.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: KT-US-478-0401
  • NCT ID: NCT03912831

Conditions

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

Interventions

DrugSynonymsArms
KITE-439KITE-439
CyclophosphamideKITE-439
FludarabineKITE-439

Purpose

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 human leukocyte antigen (HLA)-A*02:01+ adults with relapsed/refractory human papillomavirus (HPV)16+ cancers.

Trial Arms

NameTypeDescriptionInterventions
KITE-439ExperimentalPhase 1A (Dose Escalation): Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-439. Phase 1 B: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-439, at a dose selected based on Phase 1A.
  • KITE-439
  • Cyclophosphamide
  • Fludarabine

Eligibility Criteria

        Key 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

        Key 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

          -  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

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
Time Frame:Up to 21 days
Safety Issue:
Description:Dose-limiting toxicity is defined as protocol-defined KITE-439 related events with onset within the first 21 days following KITE-439 infusion.

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Up to 2 years
Safety Issue:
Description:For participants who experience an objective response, DOR is defined as the date of their first objective response, which is subsequently confirmed to the date of disease progression per modified RECIST v1.1 or death from any cause.
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:PFS is defined as the time from the KITE-439 infusion date to the date of disease progression per modified RECIST v1.1 or death from any cause.
Measure:Overall Survival
Time Frame:Up to 15 years
Safety Issue:
Description:Overall survival is defined as the time from KITE-439 infusion to the date of death.
Measure:Percentage of Participants Experiencing Adverse Events
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Percentage of Participants with Anti-KITE-439 Antibodies
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Percentage of Participants with Replication-competent Retrovirus (RCR)
Time Frame:Up to 15 years
Safety Issue:
Description:
Measure:Levels of E7 TCR T Cells
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kite, A Gilead Company

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