[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qingdao Sino-Cell Biomedicine Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100624214","phase-2-hs-it101-injection-versus-chemotherapy-in-the-treatment-of-advanced-melanoma-100624214",false,"NCT07406724","HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma","Randomized, Controlled, Open-label Phase 2 Clinical Trial of HS-IT101 Injection Versus Chemotherapy for Patients With Advanced Melanoma","Inclusion Criteria:\n\n1. Participants aged 18 to 75 years, inclusive.\n2. Patients with cytologically or histologically confirmed unresectable advanced, recurrent, or metastatic melanoma (excluding uveal melanoma), who have experienced disease progression after failure of systemic therapy recommended in the 2025 CSCO Guidelines.\n3. Disease Progression Following Anti-PD-1 Therapy.\n4. At least one tumor lesion not treated with radiotherapy or other local therapies within 28 days prior to resection, suitable for autologous tumor-infiltrating lymphocyte (TIL) preparation, with a minimum tissue weight of ≥0.050 g.\n5. At least one measurable tumor lesion per RECIST 1.1 after tumor tissue sampling.\n6. ECOG performance status ≤ 1.\n7. Expected survival ≥ 3 months.\n8. Adequate organ and bone marrow function as confirmed by screening assessments.\n9. Documented by echocardiography showing left ventricular ejection fraction (LVEF) ≥50%；Absence of arrhythmia requiring therapeutic intervention；Electrocardiogram (ECG) criteria；QT interval corrected by Frederica's formula (QTcF) ≤470 ms；Baseline peripheral oxygen saturation (SpO₂) \\>91% in room air.\n10. Adverse reactions from prior therapy have resolved to CTCAE v5.0 grade ≤1 before randomization, except for hypothyroidism and alopecia judged by the investigator as non-safety concerns.\n11. Effective non-pharmacological contraceptive measures must be used from the signing of the informed consent form until 1 year after TIL cell infusion.\n12. The subject fully understands the trial, voluntarily provides written informed consent, and is able to comply with scheduled visits and protocol-specified procedures.\n\nExclusion Criteria:\n\n1. Patients with a history of severe hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome, or toxic epidermal necrolysis) to any component of the following agents.\n2. Presence of any uncontrolled clinical conditions, including but not limited to:\n\n   * Poorly controlled hypertension (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg at rest despite antihypertensive therapy);\n   * Congestive heart failure (NYHA Class III\u002FIV).\n3. History of deep vein thrombosis (DVT) or pulmonary embolism (PE); myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism within the past 6 months.\n4. Active autoimmune diseases requiring systemic therapy during the study period（Subjects with the following conditions may be enrolled：Eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy within the last 2 years and not expected to recur, or other autoimmune diseases under stable control;Hypothyroidism requiring only thyroid hormone replacement;Type 1 diabetes requiring only insulin replacement therapy.）\n5. Organ transplant or history of hematopoietic stem cell transplantation.\n6. Use of systemic immunosuppressive agents (e.g., corticosteroids) within 4 weeks prior to randomization, or presence of comorbid conditions requiring such medications during the trial period.Exception: Intranasal or topical corticosteroids are permitted.\n7. Receipt of systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization, or planned participation in another interventional clinical trial during the study period.\n8. Acute or chronic infections, including:\n\n   * HIV-positive status, Treponema pallidum antibody positivity, or clinically active hepatitis B or C(Note: For hepatitis B, HBsAg- or HBeAg-positive individuals with HBV DNA below the lower limit of normal at the study site may be enrolled; for hepatitis C, HCVAb-positive individuals with HCV RNA below the lower limit of normal at the study site may be enrolled);\n   * Active infections requiring systemic therapy or active tuberculosis infection.\n9. Subjects who received any live attenuated vaccine within 3 months prior to screening or planning to receive live vaccines during the trial period.\n10. Subjects who have undergone major organ surgery or experienced clinically significant trauma within 4 weeks prior to screening, or require elective surgery during the trial period.\n11. Patients presenting with pre-screening surgical complications or delayed wound healing, and deemed by the investigator to confer increased risks during lymphodepleting pretreatment, adoptive TIL therapy, and high-dose IL-2 adjuvant therapy.\n12. Patients with a history of other primary malignancies diagnosed within 5 years prior to screening are excluded, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For carcinoma in situ.\n13. Patients with severe respiratory diseases (including but not limited to a documented history of or concurrent severe interstitial lung disease (ILD), severe chronic obstructive pulmonary disease (COPD), profound pulmonary insufficiency, or symptomatic bronchospasm).\n14. Patients requiring surgical intervention for gastrointestinal hemorrhage, localized intestinal ischemia, or intestinal perforation.\n15. Patients with symptomatic central nervous system (CNS) metastases\n16. Patients with clinical symptoms of central nervous system (CNS) metastases who have received prior therapy for brain metastases and maintained radiographic stability (confirmed by MRI) for at least 12 weeks may be enrolled.\n17. Pregnant or lactating women.\n18. Individuals with a known history of psychiatric disorders, alcoholism, drug abuse, or substance abuse, as well as any other conditions deemed unsuitable for participation by the investigator .","ALL","18 Years","75 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized controlled, open-label Phase II clinical study designed to evaluate the efficacy and safety of HS-IT101 Injection versus the investigator's choice of chemotherapy in participants with advanced melanoma. A total of 90 participants are planned to be enrolled, and eligible participants will be randomly assigned to the experimental group or control group at a 1:1 ratio. The experimental group will receive a single administration of autologous tumor-infiltrating lymphocyte therapy, while the control group will receive chemotherapy regimens selected by the research physicians. Efficacy and safety evaluations will be conducted for all enrolled participants throughout the study.",[27],"Melanoma (Excluding Uveal Melanoma)",[29],"Advanced Melanoma","NOT_YET_RECRUITING","2026-02-09",{"date":33,"type":34},"2026-02-12","ACTUAL",{"date":36,"type":21},"2026-02-26",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Qingdao Sino-Cell Biomedicine Co., Ltd.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100601029","phase-1-hs-it101-injection-for-advanced-nsclc-100601029","NCT07105176","HS-IT101 Injection for Advanced NSCLC","A Phase Ib Single-arm Clinical Study of HS-IT101 Injection for Advanced NSCLC","Inclusion Criteria:\n\n* Age: 18-70 years (inclusive).\n\nDiagnosis:\n\nHistologically\u002Fcytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) .\n\nTumor Sampling:\n\n≥1 lesion untreated with radiotherapy\u002Flocal therapy within 28 days for TIL preparation (tissue weight ≥0.050 g).\n\nTarget Lesion:\n\n≥1 measurable lesion per RECIST v1.1, untreated with radiotherapy\u002Flocal therapy (unless treatment occurred \\>28 days before sampling with documented progression).\n\nPerformance Status: ECOG score ≤1. Survival: Life expectancy ≥3 months.\n\nOrgan Function:\n\nHematology: ANC ≥1.5×10⁹\u002FL, PLT ≥90×10⁹\u002FL, HGB ≥90 g\u002FL (no transfusion\u002Ferythropoietin within 14 days).\n\nLiver: ALT\u002FAST ≤2.5×ULN (≤5×ULN if liver metastases); TBil ≤1.5×ULN (≤3×ULN for Gilbert syndrome).\n\nKidney: Serum Cr ≤1.5×ULN or Ccr ≥60 mL\u002Fmin (Cockcroft-Gault formula). Coagulation: APTT ≤1.5×ULN; INR\u002FPT ≤1.5×ULN.\n\nCardiac Function:\n\nLVEF ≥50% by echocardiography; QTcF ≤470 ms (Fridericia formula: QTcF = QT\u002FRR⁰·³³).\n\nBaseline SpO₂ \\>91% (room air). Note: If QTcF is abnormal initially, repeat twice at ≥5-minute intervals and use mean value for eligibility.\n\nToxicity Recovery: All treatment-related adverse events resolved to CTCAE v5.0 ≤Grade 1 (except alopecia\u002Fnon-risk toxicities per investigator) before tumor sampling.\n\nContraception: Effective non-pharmacological contraception from informed consent until 1 year post-TIL infusion.\n\nCompliance: Capable of understanding the trial, voluntarily signing informed consent, and adhering to protocol visits\u002Fprocedures.\n\nExclusion Criteria:\n\n* Severe Hypersensitivity: History of severe hypersensitivity to drugs used in the study (including but not limited to cyclophosphamide, fludarabine, IL-2, gentamicin, amphotericin B, or components of TIL infusion).\n\nUncontrolled Comorbidities:\n\nPoorly controlled hypertension (resting SBP ≥160 mmHg or DBP ≥100 mmHg despite medication).\n\nCongestive heart failure (NYHA Class III\u002FIV).\n\nCardiovascular Events (within 6 months):\n\nDeep vein thrombosis, pulmonary embolism, myocardial infarction, severe\u002Funstable arrhythmia, angina, PCI, ACS, CABG, stroke, TIA, or cerebral embolism.\n\nActive Autoimmune Disease:\n\nRequires systemic therapy during the study period (Exceptions: Eczema, vitiligo, psoriasis, alopecia, or Graves' disease stable without systemic therapy for 2 years; hypothyroidism on hormone replacement; type 1 diabetes on insulin).\n\nTransplantation History: Solid organ or hematopoietic stem cell transplantation.\n\nImmunosuppressive Therapy:\n\nUse of immunosuppressants (e.g., steroids) within 4 weeks before tumor sampling (Allowed: Physiologic glucocorticoid doses ≤12 mg\u002Fm²\u002Fday hydrocortisone equivalent; topical\u002Fnasal steroids).\n\nRecent Anticancer Therapy:\n\nSystemic anticancer treatment within 4 weeks before preconditioning (including investigational drugs; washout \\\u003C5 half-lives if \\\u003C4 weeks).\n\nPlanned participation in other interventional trials.\n\nActive Infections:\n\nHIV\u002Fsyphilis antibody-positive; active HBV\u002FHCV (Allowed: HBsAg\u002FHBeAg+ if HBV DNA below LLN; HCV Ab+ if HCV RNA below LLN).\n\nActive systemic infection or tuberculosis requiring treatment. Recent Surgery\u002FTrauma: Major surgery or significant trauma within 4 weeks before screening; elective surgery planned during the study.\n\nPoor Wound Healing: Surgery-related complications or delayed healing increasing risks of TIL therapy (per investigator judgment).\n\nOther Malignancies: Additional primary malignancy within 5 years (Exceptions: Curatively treated basal\u002Fsquamous cell carcinoma or carcinoma in situ).\n\nSevere Respiratory Disease: History of severe ILD, COPD, pulmonary insufficiency, or symptomatic bronchospasm.\n\nGastrointestinal Complications: Surgical-required GI bleeding, bowel ischemia, or perforation.\n\nCNS Involvement:\n\nLeptomeningeal metastasis; uncontrolled\u002Funtreated CNS metastases (Exceptions: Asymptomatic lesions \\\u003C1 cm, stable for ≥4 weeks without steroids\u002Fanticonvulsants).\n\nPrior Cell Therapy: Previous treatment with similar cellular products. Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n\nOther Exclusions:\n\nPsychiatric disorders, alcoholism, drug abuse, or other conditions deemed unsuitable by the investigator.","70 Years",{"count":51,"type":21},12,[53],"PHASE1","An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.",[56],"Advanced Non-Small Cell Lung Cancer","2025-08-18",{"date":59,"type":34},"2025-08-19",{"date":61,"type":21},"2025-08-30",{"date":63,"type":21},"2027-08-30",{"name":40,"class":41},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100563206","early-phase-1-hs-it201-injection-in-the-treatment-of-advanced-solid-tumors-100563206","NCT06613152","HS-IT201 Injection in the Treatment of Advanced Solid Tumors","Clinical Study on the Safety and Efficacy of HS-IT201 Injection in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* To be eligible for the study, patients must meet ALL of the following criteria prior to participation:\n\n  1. Age: 18 years to 75 years at the time of consent;\n  2. Diagnosis by cytology or histology, failure to standard treatment (including disease progression and\u002For adverse reactions are not tolerated) or are judged by the investigator to be unsuitable for the use of existing standards Treatment methods for patients with advanced solid tumors, including but not limited to kidney cancer, non-small cells Lung cancer, stomach cancer, colorectal cancer, melanoma, etc. Participants are required to have a minimum of menstruation Through first-line treatment.\n  3. At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；or resectable lesions capable of producing sufficient TIL;\n  4. At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression;\n  5. ECOG score 0-1;\n  6. Expected life-span more than 3 months;\n  7. Adequate organ and bone marrow function:\n\n     Absolute count of neutrophil ≥1.5×10\\^9\u002FL; Platelet count ≥90×10\\^9\u002FL; Hemoglobin ≥ 90g\u002FL; AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN（Gilbert syndrome≤3×ULN）; Serum creatinine ≤1.5×ULN, or estimated creatinine clearance (CrCl)≥60 mL\u002Fmin (Cockcroft-Gault formula); Activated partial thromboplastin time (APTT) ≤1.5×ULN, while international normalized ratio (INR) or prothrombin (PT) ≤1.5×ULN;\n  8. Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; Arrhythmias that do not require treatment, the QT interval (QTcF) corrected by the Fridericia method is ≤ 470 ms (QTcF is calculated using the Fridericia formula, i.e. QTcF=QT\u002F(RR \\^ 0.33), RR is the standardized heart rate value, RR=60\u002Fheart rate); If there is an abnormality during the first inspection, it can be retested twice with an interval of at least 5 minutes, and the overall result\u002Faverage value should be taken to determine the qualification; Basic blood oxygen saturation in indoor natural air environment\\>91%;\n  9. Test subjects must have recovered from all prior therapy-related toxicities to ≤Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for alopecia (tumor resection);\n  10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of treatment;\n  11. Be able to understand and sign the informed consent document.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will not be allowed to participation:\n\n  1. Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);\n  2. Test subjects have any uncontrollable clinical problems (including but not limited):\n\n     hypertension poorly controlled by medication (blood pressure ≥160\u002F100mmHg at rest after taking medication); poorly controlled diabetes; cardiac disease (New York Heart Association class Ⅲ\u002FⅣ congestive heart failure or heart block);\n  3. Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;\n  4. Active autoimmune diseases that require systemic treatment during the study period (eczema, vitiligo, psoriasis, alopecia or Grave\\'s disease that do not require systematic treatment in the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes subjects that only require insulin replacement therapy can be included);\n  5. Organ transplantation and a history of hematopoietic stem cell transplantation;\n  6. Any immunosuppressive drugs, such as steroids, have been used within 4 weeks prior to tumor tissue sampling, or the researcher has determined the presence of comorbidities that require the use of immunosuppressive drugs during the trial period. However, physiological doses of glucocorticoids (i.e. ≤ 12 mg\u002Fm2\u002Fday of hydrocortisone or other hormones within the equivalent dose range after equivalent dose conversion) are allowed, and steroid drugs are allowed for intranasal or local use;\n  7. Individuals who have received systematic anti-tumor therapy within 4 weeks prior to pre-treatment (including those who have participated in other clinical trial drug treatments; those who have metabolized 5 drugs with a half-life of less than 4 weeks, whichever is shorter) or those who plan to participate in other intervention clinical trials during the study period;\n  8. Presence of acute or chronic infection:\n\n     HIV positive, Treponema pallidum antibody positive, or clinically active hepatitis B and C, including virus carriers (excluding HBsAg and\u002For HBeAg positive individuals for hepatitis B; excluding HCVAb positive individuals for hepatitis C);Active infections or active tuberculosis infections that require systemic treatment;\n  9. Vaccinated with the new coronavirus vaccine within 4 weeks propr to screening, or who have received a live vaccine within 3 months, or who plan to receive live vaccine during the trial;\n  10. Major organs underwent surgery (excluding needle biopsy) or significant trauma within 4 weeks before screening；required elective surgery during the study;\n  11. Patients who have surgical complications or delayed healing prior to screening, and have been determined by the researchers to increase the risk of gonorrhea pretreatment, adoptive TIL therapy, and IL-2 adjuvant therapy;\n  12. Test subjects who have had another primary malignancy within the previous 5 years, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after radical resection;\n  13. Suffering from severe respiratory system diseases (with a history of or combined with severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, and symptomatic bronchospasm);\n  14. Patients with gastrointestinal bleeding requiring surgical treatment, local intestinal ischemia or perforation;\n  15. Patients with known meninges metastasis; Patients with known uncontrolled or untreated central nervous system metastases (excluding those who have received stable treatment symptoms and stopped glucocorticoid and anticonvulsant drug treatment ≥ 4 weeks prior to pre-treatment);\n  16. Previously received similar cell therapy products;\n  17. Females in pregnancy or lactation;\n  18. Subject have mental illness, alcoholism, drug or substance abuse；or researchers considering the test subject as having other reasons inappropriate for the clinical study.",{"count":74,"type":21},9,[76],"EARLY_PHASE1","Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT201) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.",[79],"Solid Tumor","2024-09-22",{"date":82,"type":34},"2024-09-25",{"date":84,"type":21},"2024-10",{"date":86,"type":21},"2028-10",{"name":40,"class":41},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":65},"100542397","phase-1-hs-it101-injection-in-the-treatment-of-advanced-solid-tumors-100542397","NCT06342336","HS-IT101 Injection in the Treatment of Advanced Solid Tumors","Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* To be eligible for the study, patients must meet ALL of the following criteria prior to participation:\n\n  1. Age: 18 years to 75 years at the time of consent;\n  2. Histologically or cytological diagnosed as advanced soild tumor:\n  3. At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；or resectable lesions capable of producing sufficient TIL;\n  4. At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression;\n  5. ECOG score 0-1;\n  6. Expected life-span more than 3 months;\n  7. Adequate organ and bone marrow function:\n\n     Absolute count of neutrophil ≥1.5×10\\^9\u002FL; Platelet count ≥90×10\\^9\u002FL; Hemoglobin ≥ 90g\u002FL; AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN（Gilbert syndrome≤3×ULN）; Serum creatinine ≤1.5×ULN, or estimated creatinine clearance (CrCl)≥60 mL\u002Fmin (Cockcroft-Gault formula); Activated partial thromboplastin time (APTT) ≤1.5×ULN, while international normalized ratio (INR) or prothrombin (PT) ≤1.5×ULN;\n  8. Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; Arrhythmias that do not require treatment, the QT interval (QTcF) corrected by the Fridericia method is ≤ 470 ms (QTcF is calculated using the Fridericia formula, i.e. QTcF=QT\u002F(RR \\^ 0.33), RR is the standardized heart rate value, RR=60\u002Fheart rate); If there is an abnormality during the first inspection, it can be retested twice with an interval of at least 5 minutes, and the overall result\u002Faverage value should be taken to determine the qualification; Basic blood oxygen saturation in indoor natural air environment\\>91%;\n  9. Test subjects must have recovered from all prior therapy-related toxicities to ≤Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for alopecia (tumor resection);\n  10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of treatment;\n  11. Be able to understand and sign the informed consent document.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will not be allowed to participation:\n\n  1. Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);\n  2. Test subjects have any uncontrollable clinical problems (including but not limited):\n\n     hypertension poorly controlled by medication (blood pressure ≥160\u002F100mmHg at rest after taking medication); poorly controlled diabetes; cardiac disease (New York Heart Association class Ⅲ\u002FⅣ congestive heart failure or heart block);\n  3. Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;\n  4. Active autoimmune diseases that require systemic treatment during the study period (eczema, vitiligo, psoriasis, alopecia or Grave's disease that do not require systematic treatment in the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes subjects that only require insulin replacement therapy can be included);\n  5. Organ transplantation and a history of hematopoietic stem cell transplantation;\n  6. Any immunosuppressive drugs, such as steroids, have been used within 4 weeks prior to tumor tissue sampling, or the researcher has determined the presence of comorbidities that require the use of immunosuppressive drugs during the trial period. However, physiological doses of glucocorticoids (i.e. ≤ 12 mg\u002Fm2\u002Fday of hydrocortisone or other hormones within the equivalent dose range after equivalent dose conversion) are allowed, and steroid drugs are allowed for intranasal or local use;\n  7. Individuals who have received systematic anti-tumor therapy within 4 weeks prior to pre-treatment (including those who have participated in other clinical trial drug treatments; those who have metabolized 5 drugs with a half-life of less than 4 weeks, whichever is shorter) or those who plan to participate in other intervention clinical trials during the study period;\n  8. Presence of acute or chronic infection:\n\n     HIV positive, Treponema pallidum antibody positive, or clinically active hepatitis B and C, including virus carriers (excluding HBsAg and\u002For HBeAg positive individuals for hepatitis B; excluding HCVAb positive individuals for hepatitis C);Active infections or active tuberculosis infections that require systemic treatment;\n  9. Vaccinated with the new coronavirus vaccine within 4 weeks propr to screening, or who have received a live vaccine within 3 months, or who plan to receive live vaccine during the trial;\n  10. Major organs underwent surgery (excluding needle biopsy) or significant trauma within 4 weeks before screening；required elective surgery during the study;\n  11. Patients who have surgical complications or delayed healing prior to screening, and have been determined by the researchers to increase the risk of gonorrhea pretreatment, adoptive TIL therapy, and IL-2 adjuvant therapy;\n  12. Test subjects who have had another primary malignancy within the previous 5 years, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after radical resection;\n  13. Suffering from severe respiratory system diseases (with a history of or combined with severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, and symptomatic bronchospasm);\n  14. Patients with gastrointestinal bleeding requiring surgical treatment, local intestinal ischemia or perforation;\n  15. Patients with known meninges metastasis; Patients with known uncontrolled or untreated central nervous system metastases (excluding those who have received stable treatment symptoms and stopped glucocorticoid and anticonvulsant drug treatment ≥ 4 weeks prior to pre-treatment);\n  16. Previously received similar cell therapy products;\n  17. Females in pregnancy or lactation;\n  18. Subject have mental illness, alcoholism, drug or substance abuse；or researchers considering the test subject as having other reasons inappropriate for the clinical study.","18 Days","75 Days",{"count":98,"type":21},44,[53],"Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.",[79],"RECRUITING","2024-03-25",{"date":105,"type":34},"2024-04-02",{"date":107,"type":34},"2024-01-18",{"date":109,"type":21},"2028-03-31",{"name":40,"class":41},""]