{
    "info": {
        "nct_id": "NCT03843294",
        "official_title": "Phase I Study Utilizing Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor Nivolumab for Relapsed/Refractory Lymphoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 12 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Disease Specific Inclusion Criteria\n\nGroup A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B cell Lymphoma (DLBCL) DLBCL\n\n* Patients who have failed at least 2 lines of prior therapy with a failed attempt at both an autologous stem cell transplant and chimeric antigen receptor T cell therapy.\n* Patients who are deemed autologous stem cell transplant ineligible and have failed only one line of prior therapy.\n* Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy unless the treatment was anti-CD20 antibody monotherapy.\n\nHL\n\n* Rel/ref HL failing more than or equal to 1 salvage regimens, including prior Brentuximab Vedotin (BV)\n* Rel/ref after autologous HSCT\n\nGroup B (consolidation after auto-HSCT for patients at high risk for relapse) DLBCL\n\n* Patients with < CMR/CR (by PET/CT) with initial treatment regimen\n* Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy\n* Patients with <CMR/CR (by PET/CT) prior to autologous HSCT\n* Patients requiring >1 salvage regimen prior to autologous HSCT HL\n* Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy\n* Patients with <CMR/CR (by PET/CT) prior to autologous HSCT\n* Patients requiring >1 salvage regimen prior to autologous HSCT\n\nRecipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):\n\n* Age >12 years\n* Karnofsky/Lansky score of more than or equal to 50 (see appendix C).\n* ALC > 600\n* Patients receiving Granulocyte colony-stimulating factor (G-CSF) are recommended a washout period of a minimum of two weeks before procurement\n* Agree to use contraceptive measures during study protocol participation (when age appropriate)\n* Patient or parent/guardian capable of providing informed consent\n\nRecipient Exclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):\n\n* Prior allogeneic BMT\n* Prior solid organ transplant\n* Patient who has received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment\n* Patient with uncontrolled infections\n* Patient with active HIV\n* Pregnancy or lactating\n* Failure to meet institutional guidelines for treatment with Nivolumab\n\nRecipient Inclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:\n\n* Age >12 years\n* Patient has received at least 8 weeks of Nivolumab\n* Patients with Grade 1 toxicities attributed to Nivolumab will be eligible at the discretion of the PI. Toxicities include but not limited to: laboratory abnormalities in thyroid function tests suggestive of hypothyroidism, thyroiditis or thyroid dysfunction adequately managed with thyroid hormone replacement, or abnormalities in amylase, lipase\n* Steroids less than 0.5 mg/kg/day prednisone or equivalent\n* Karnofsky/Lansky score of more than or equal to 50\n* Pulse oximetry of > 90% on room air\n* Bilirubin less than or equal to 2.5 mg/dL, AST/ALT less than or equal to 5x upper limit of normal, serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)\n* Absolute neutrophil count > 250/µL (may be supported with GCSF)\n* Agree to use contraceptive measures during study protocol participation (when age appropriate)\n* Patient or parent/guardian capable of providing informed consent\n\nRecipient Exclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:\n\n* Investigational therapies within 28 days prior to screening for enrollment\n* Uncontrolled infections\n* Patient with ≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies"
    },
    "inclusion_lines": [
        {
            "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 12 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 12 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Disease Specific Inclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "Disease Specific Inclusion Criteria",
                    "criterion": "disease-specific inclusion",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "inclusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Group A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B cell Lymphoma (DLBCL) DLBCL",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Relapsed/Refractory Hodgkin Lymphoma (HL)",
                    "criterion": "Hodgkin Lymphoma (HL)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Diffuse Large B cell Lymphoma (DLBCL)",
                    "criterion": "Diffuse Large B cell Lymphoma (DLBCL)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have failed at least 2 lines of prior therapy with a failed attempt at both an autologous stem cell transplant and chimeric antigen receptor T cell therapy.",
            "criterions": [
                {
                    "exact_snippets": "failed at least 2 lines of prior therapy",
                    "criterion": "prior therapy lines failed",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "failed attempt at both an autologous stem cell transplant",
                    "criterion": "autologous stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "attempt",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed attempt at ... chimeric antigen receptor T cell therapy",
                    "criterion": "chimeric antigen receptor T cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "attempt",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are deemed autologous stem cell transplant ineligible and have failed only one line of prior therapy.",
            "criterions": [
                {
                    "exact_snippets": "autologous stem cell transplant ineligible",
                    "criterion": "autologous stem cell transplant eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "failed only one line of prior therapy",
                    "criterion": "lines of prior therapy failed",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy unless the treatment was anti-CD20 antibody monotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy",
                    "criterion": "previous DLBCL lines of therapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "Systemic therapies to treat prior indolent lymphomas"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the treatment was anti-CD20 antibody monotherapy",
                    "criterion": "anti-CD20 antibody monotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "HL",
            "criterions": [
                {
                    "exact_snippets": "HL",
                    "criterion": "Hodgkin Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rel/ref HL failing more than or equal to 1 salvage regimens, including prior Brentuximab Vedotin (BV)",
            "criterions": [
                {
                    "exact_snippets": "Rel/ref HL failing more than or equal to 1 salvage regimens",
                    "criterion": "salvage regimens",
                    "requirements": [
                        {
                            "requirement_type": "failure count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including prior Brentuximab Vedotin (BV)",
                    "criterion": "prior Brentuximab Vedotin (BV)",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rel/ref after autologous HSCT",
            "criterions": [
                {
                    "exact_snippets": "Rel/ref after autologous HSCT",
                    "criterion": "disease status after autologous HSCT",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Group B (consolidation after auto-HSCT for patients at high risk for relapse) DLBCL",
            "criterions": [
                {
                    "exact_snippets": "consolidation after auto-HSCT",
                    "criterion": "consolidation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after auto-HSCT"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients at high risk for relapse",
                    "criterion": "risk for relapse",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "DLBCL",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with < CMR/CR (by PET/CT) with initial treatment regimen",
            "criterions": [
                {
                    "exact_snippets": "< CMR/CR (by PET/CT)",
                    "criterion": "CMR/CR status",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "CMR/CR"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "initial treatment regimen",
                    "criterion": "treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "initial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy",
            "criterions": [
                {
                    "exact_snippets": "relapse <12 months from diagnosis",
                    "criterion": "relapse from diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse ... <6 months from completion of initial therapy",
                    "criterion": "relapse from completion of initial therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion of initial therapy",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with <CMR/CR (by PET/CT) prior to autologous HSCT",
            "criterions": [
                {
                    "exact_snippets": "<CMR/CR (by PET/CT)",
                    "criterion": "response to treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "less than complete metabolic response/complete response"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients requiring >1 salvage regimen prior to autologous HSCT HL",
            "criterions": [
                {
                    "exact_snippets": "Patients requiring >1 salvage regimen",
                    "criterion": "salvage regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to autologous HSCT HL",
                    "criterion": "autologous HSCT HL",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with <CMR/CR (by PET/CT) prior to autologous HSCT",
            "criterions": [
                {
                    "exact_snippets": "<CMR/CR (by PET/CT)",
                    "criterion": "response to treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "less than complete metabolic response/complete response"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients requiring >1 salvage regimen prior to autologous HSCT",
            "criterions": [
                {
                    "exact_snippets": "Patients requiring >1 salvage regimen",
                    "criterion": "salvage regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to autologous HSCT",
                    "criterion": "autologous HSCT",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):",
            "criterions": [
                {
                    "exact_snippets": "Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation)",
                    "criterion": "recipient inclusion",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": "initial and subsequent procurements (TAA-T Cell Generation)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >12 years",
            "criterions": [
                {
                    "exact_snippets": "Age >12 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky/Lansky score of more than or equal to 50 (see appendix C).",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky/Lansky score of more than or equal to 50",
                    "criterion": "Karnofsky/Lansky score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALC > 600",
            "criterions": [
                {
                    "exact_snippets": "ALC > 600",
                    "criterion": "ALC",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 600,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving Granulocyte colony-stimulating factor (G-CSF) are recommended a washout period of a minimum of two weeks before procurement",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving Granulocyte colony-stimulating factor (G-CSF)",
                    "criterion": "Granulocyte colony-stimulating factor (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a washout period of a minimum of two weeks before procurement",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use contraceptive measures during study protocol participation (when age appropriate)",
            "criterions": [
                {
                    "exact_snippets": "Agree to use contraceptive measures during study protocol participation",
                    "criterion": "use of contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "when age appropriate",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for contraceptive use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient or parent/guardian capable of providing informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient or parent/guardian capable of providing informed consent",
                    "criterion": "informed consent capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic BMT",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic BMT",
                    "criterion": "allogeneic BMT",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior solid organ transplant",
            "criterions": [
                {
                    "exact_snippets": "Prior solid organ transplant",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who has received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment",
            "criterions": [
                {
                    "exact_snippets": "Patient who has received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening",
                    "criterion": "immunosuppressive T cell monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with uncontrolled infections",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with active HIV",
            "criterions": [
                {
                    "exact_snippets": "active HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactating",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure to meet institutional guidelines for treatment with Nivolumab",
            "criterions": [
                {
                    "exact_snippets": "Failure to meet institutional guidelines for treatment with Nivolumab",
                    "criterion": "institutional guidelines for treatment with Nivolumab",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >12 years",
            "criterions": [
                {
                    "exact_snippets": "Age >12 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received at least 8 weeks of Nivolumab",
            "criterions": [
                {
                    "exact_snippets": "Patient has received at least 8 weeks of Nivolumab",
                    "criterion": "Nivolumab treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Grade 1 toxicities attributed to Nivolumab will be eligible at the discretion of the PI. Toxicities include but not limited to: laboratory abnormalities in thyroid function tests suggestive of hypothyroidism, thyroiditis or thyroid dysfunction adequately managed with thyroid hormone replacement, or abnormalities in amylase, lipase",
            "criterions": [
                {
                    "exact_snippets": "Grade 1 toxicities attributed to Nivolumab",
                    "criterion": "Grade 1 toxicities",
                    "requirements": [
                        {
                            "requirement_type": "attribution",
                            "expected_value": "Nivolumab"
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities in thyroid function tests suggestive of hypothyroidism",
                    "criterion": "thyroid function tests",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": "suggestive of hypothyroidism"
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroiditis or thyroid dysfunction adequately managed with thyroid hormone replacement",
                    "criterion": "thyroiditis or thyroid dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": "adequately managed with thyroid hormone replacement"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormalities in amylase, lipase",
                    "criterion": "amylase, lipase",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Steroids less than 0.5 mg/kg/day prednisone or equivalent",
            "criterions": [
                {
                    "exact_snippets": "Steroids less than 0.5 mg/kg/day prednisone or equivalent",
                    "criterion": "steroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "mg/kg/day prednisone or equivalent"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky/Lansky score of more than or equal to 50",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky/Lansky score of more than or equal to 50",
                    "criterion": "Karnofsky/Lansky score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulse oximetry of > 90% on room air",
            "criterions": [
                {
                    "exact_snippets": "Pulse oximetry of > 90%",
                    "criterion": "pulse oximetry",
                    "requirements": [
                        {
                            "requirement_type": "oxygen saturation",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than or equal to 2.5 mg/dL, AST/ALT less than or equal to 5x upper limit of normal, serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than or equal to 2.5 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST/ALT less than or equal to 5x upper limit of normal",
                    "criterion": "AST/ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 1.0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "x upper limit of normal"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 250/µL (may be supported with GCSF)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 250/µL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use contraceptive measures during study protocol participation (when age appropriate)",
            "criterions": [
                {
                    "exact_snippets": "Agree to use contraceptive measures",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age appropriate",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "age appropriate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient or parent/guardian capable of providing informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient or parent/guardian capable of providing informed consent",
                    "criterion": "capability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Investigational therapies within 28 days prior to screening for enrollment",
            "criterions": [
                {
                    "exact_snippets": "Investigational therapies within 28 days prior to screening for enrollment",
                    "criterion": "investigational therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled infections",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with ≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies",
            "criterions": [
                {
                    "exact_snippets": "≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies",
                    "criterion": "non-hematologic toxicities from prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy",
            "criterions": [
                {
                    "exact_snippets": "relapse <12 months from diagnosis",
                    "criterion": "relapse from diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse <6 months from completion of initial therapy",
                    "criterion": "relapse from completion of initial therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion of initial therapy",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Recipient Exclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):",
            "criterions": []
        },
        {
            "line": "Recipient Inclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:",
            "criterions": []
        },
        {
            "line": "Recipient Exclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:",
            "criterions": []
        }
    ]
}