{
"info": {
"nct_id": "NCT06088472",
"official_title": "A Single-arm Phase I Clinical Study of TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors",
"inclusion_criteria": "* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥0.5cm (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);\n* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);\n* 3. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;\n* 5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;\n* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",
"miscellaneous_criteria": ""
},
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"line": "* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;",
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"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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},
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"value": 5,
"unit": "months"
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}
},
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}
},
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},
{
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}
},
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"and_criteria": [
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"line": "* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;",
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},
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{
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},
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}
},
{
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]
}
},
{
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"line": "* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;",
"criterions": [
{
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"criterion": "allogeneic bone marrow transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have received ... an organ allograft",
"criterion": "organ allograft",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Patients who have received allogeneic bone marrow transplantation",
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"expected_value": true
}
},
{
"exact_snippets": "Patients who have received ... an organ allograft",
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}
}
]
}
},
{
"identified_line": {
"line": "* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",
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{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... cyclophosphamide",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... fludarabine",
"criterion": "hypersensitivity to fludarabine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... IL-2",
"criterion": "hypersensitivity to IL-2",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dimethyl sulfoxide (DMSO)",
"criterion": "hypersensitivity to dimethyl sulfoxide (DMSO)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... human serum albumin (HSA)",
"criterion": "hypersensitivity to human serum albumin (HSA)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dextran-40",
"criterion": "hypersensitivity to dextran-40",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... antibiotics (beta lactam antibiotics, gentamicin)",
"criterion": "hypersensitivity to antibiotics (beta lactam antibiotics, gentamicin)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes",
"criterion": "hypersensitivity to autologous tumor infiltrating lymphocytes",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... cyclophosphamide",
"criterion": "hypersensitivity to cyclophosphamide",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... fludarabine",
"criterion": "hypersensitivity to fludarabine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... IL-2",
"criterion": "hypersensitivity to IL-2",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dimethyl sulfoxide (DMSO)",
"criterion": "hypersensitivity to dimethyl sulfoxide (DMSO)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... human serum albumin (HSA)",
"criterion": "hypersensitivity to human serum albumin (HSA)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dextran-40",
"criterion": "hypersensitivity to dextran-40",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... antibiotics (beta lactam antibiotics, gentamicin)",
"criterion": "hypersensitivity to antibiotics (beta lactam antibiotics, gentamicin)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}