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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 : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer Drug: KITE-439 Drug: Cyclophosphamide Drug: Fludarabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2036

Arm Intervention/treatment
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.

Drug: KITE-439
A single infusion of E7 T-cell receptor (TCR) T cells (KITE-439)

Drug: Cyclophosphamide
Administered intravenously

Drug: Fludarabine
Administered intravenously




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall Survival [ Time Frame: Up to 15 years ]
    Overall survival is defined as the time from KITE-439 infusion to the date of death.

  4. Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 15 years ]
  5. Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: Up to 15 years ]
  6. Percentage of Participants with Anti-KITE-439 Antibodies [ Time Frame: Up to 2 years ]
  7. Percentage of Participants with Replication-competent Retrovirus (RCR) [ Time Frame: Up to 15 years ]
  8. Levels of E7 TCR T Cells [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912831


Contacts
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Contact: Medical Information 1-844-454-5483(1-844-454-KITE) medinfo@kitepharma.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Claudia Aceves       caceves@coh.org   
Principal Investigator: Erminia Massarelli, MD         
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Caitlyn Ward       Caitlyn.Ward@moffitt.org   
Principal Investigator: Kedar Kirtane, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60640
Contact: John Tyson       jtyson3@medicine.bsd.uchicago.edu   
Principal Investigator: Michael Bishop, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Parth Patel       patelp5@mskcc.org   
Principal Investigator: Chris Klebanoff, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Debora Clay       daclay@mdanderson.org   
Principal Investigator: George Blumenschein, MD         
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Kite Study Director Kite, A Gilead Company

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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT03912831     History of Changes
Other Study ID Numbers: KT-US-478-0401
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites