{
    "info": {
        "nct_id": "NCT03912831",
        "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",
        "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\n* HPV16+ tumor as confirmed by the central laboratory\n* HLA type is HLA-A*02:01+ per local assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management\n\n  * 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\n* Primary immunodeficiency\n* 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\n* 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\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Advanced cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed or refractory disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "after at least 1 line of therapy",
                    "criterion": "previous therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line of therapy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "included systemic chemotherapy",
                    "criterion": "previous therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "systemic chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to definitive locoregional therapy",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HPV16+ tumor as confirmed by the central laboratory",
            "criterions": [
                {
                    "exact_snippets": "HPV16+ tumor",
                    "criterion": "HPV16+ tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by the central laboratory",
                    "criterion": "confirmation by central laboratory",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HLA type is HLA-A*02:01+ per local assessment",
            "criterions": [
                {
                    "exact_snippets": "HLA type is HLA-A*02:01+",
                    "criterion": "HLA type",
                    "requirements": [
                        {
                            "requirement_type": "specific type",
                            "expected_value": "HLA-A*02:01+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management",
            "criterions": [
                {
                    "exact_snippets": "Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "fungal",
                                "bacterial",
                                "viral",
                                "other"
                            ]
                        },
                        {
                            "requirement_type": "management",
                            "expected_value": "requiring anti-microbials"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Simple urinary tract infection (UTI) ... are permitted if responding to active treatment",
                    "criterion": "simple urinary tract infection (UTI)",
                    "requirements": [
                        {
                            "requirement_type": "response to treatment",
                            "expected_value": "responding to active treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncomplicated bacterial pharyngitis ... are permitted if responding to active treatment",
                    "criterion": "uncomplicated bacterial pharyngitis",
                    "requirements": [
                        {
                            "requirement_type": "response to treatment",
                            "expected_value": "responding to active treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary immunodeficiency",
            "criterions": [
                {
                    "exact_snippets": "Primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus)",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting in end organ injury",
                    "criterion": "end organ injury",
                    "requirements": [
                        {
                            "requirement_type": "result_of_autoimmune_disease",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment",
                    "criterion": "systemic immunosuppression/systemic disease modifying agents",
                    "requirements": [
                        {
                            "requirement_type": "requirement_for_autoimmune_disease",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time_frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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",
            "criterions": [
                {
                    "exact_snippets": "Known history of infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of infection with ... hepatitis B (HBsAg positive)",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of infection with ... hepatitis C (anti-HCV positive)",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of treated hepatitis B ... if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing",
                    "criterion": "treated hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "viral load",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of treated ... hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing",
                    "criterion": "treated hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "viral load",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined Inclusion/Exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Key",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": []
        }
    ]
}