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

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ClinicalTrials.gov Identifier: NCT03912831
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]
    Dose-limiting toxicity is defined as protocol-defined KITE-439 related events with onset within the first 21 days following KITE-439 infusion.
  • Phase 1B - Efficacy: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR is defined as the incidence of a complete response (CR) or a partial response (PR) for participants evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03912831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    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.
  • Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]
    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.
  • Overall Survival [ Time Frame: Up to 15 years ]
    Overall survival is defined as the time from KITE-439 infusion to the date of death.
  • Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 15 years ]
  • Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: Up to 15 years ]
  • Percentage of Participants with Anti-KITE-439 Antibodies [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Replication-competent Retrovirus (RCR) [ Time Frame: Up to 15 years ]
  • Levels of E7 TCR T Cells [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Official Title  ICMJE 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
Brief 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 human leukocyte antigen (HLA)-A*02:01+ adults with relapsed/refractory human papillomavirus (HPV)16+ cancers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Intervention  ICMJE
  • Drug: KITE-439
    A single infusion of E7 T-cell receptor (TCR) T cells (KITE-439)
  • Drug: Cyclophosphamide
    Administered intravenously
  • Drug: Fludarabine
    Administered intravenously
Study Arms  ICMJE Experimental: KITE-439

Phase 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.

Interventions:
  • Drug: KITE-439
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2036
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Information 1-844-454-5483(1-844-454-KITE) medinfo@kitepharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03912831
Other Study ID Numbers  ICMJE KT-US-478-0401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences ( Kite, A Gilead Company )
Study Sponsor  ICMJE Kite, A Gilead Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kite Study Director Kite, A Gilead Company
PRS Account Gilead Sciences
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP