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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03912831
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : June 16, 2021
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 : 51 participants
Allocation: N/A
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 : August 2022
Estimated Study Completion Date : August 2037

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 time from the date of their first objective response 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 with Anti-KITE-439 Antibodies [ Time Frame: Up to 2 years ]
  6. Percentage of Participants with Replication-competent Retrovirus (RCR) [ Time Frame: Up to 15 years ]
  7. Levels of E7 TCR T Cells [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT03912831

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Contact: Medical Information 1-844-454-5483(1-844-454-KITE)

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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Klarissa Jones    602-747-3647   
Principal Investigator: Jiaxin Niu, M.D.         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Claudia Aceves    626-218-5114   
Principal Investigator: Erminia Massarelli, M.D.         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Gina Khachatrian    310-794-7707   
Principal Investigator: Gottfried Konecny, M.D.         
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Edelman    813-745-1040   
Principal Investigator: Kedar Kirtane, M.D.         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60640
Contact: Michael Gomez    773-834-5314   
Principal Investigator: Michael Bishop, M.D.         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Caroline Falvey    617-582-9567   
Principal Investigator: Glenn Hanna, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Parth Patel    646-888-4424   
Principal Investigator: Chris Klebanoff, M.D.         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Debora Clay    877-632-6789   
Principal Investigator: George Blumenschein, M.D.         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Monica Dherin    206-667-3403   
Principal Investigator: Sylvia Lee, M.D.         
Sponsors and Collaborators
Kite, A Gilead Company
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Study Director: Kite Study Director Kite, A Gilead Company
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Responsible Party: Kite, A Gilead Company Identifier: NCT03912831    
Other Study ID Numbers: KT-US-478-0401
2020-005455-20 ( EudraCT Number )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
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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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists