[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601029":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":23,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":23,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":23,"overallStatus":79,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Qingdao Sino-Cell Biomedicine Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-IT101 monotherapy","EXPERIMENTAL","TIL Injection administered by intravenous infusion over 30-60 minutes.",[13,14,15,16],"Drug: Cyclophosphamide","Drug: Fludarabine","Drug: IL-2 (interleukin 2)","Drug: HS-IT101 monotherapy",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Cyclophosphamide","Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Fludarabine","Fludarabine is administered once daily via intravenous infusion for 4 consecutive days.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"IL-2 (interleukin 2)","IL-2 administered subcutaneously once daily. Dosing may be adjusted based on subject tolerance, including modifications to dose quantity, administration frequency, or complete treatment discontinuation, with a maximum treatment duration of 3 days.",[9],{"type":19,"name":9,"description":11,"armGroupLabels":33,"otherNames":23},[9],[35],{"name":36,"role":37,"phone":38,"phoneExt":23,"email":39},"WenNa.Liu","CONTACT","（86）400-6786-208","med@sino-cellbiomed.com",[41],{"facility":42,"status":23,"city":43,"state":44,"zip":23,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Guangdong Provincial People's Hospital","Guangzhou","Guangdong","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":23,"email":57},"YiLong Wu","86-020-83525173","gdghospital_ec@gdph.org.cn",{"type":59,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100601029","phase-1-hs-it101-injection-for-advanced-nsclc-100601029",false,"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.","ALL","18 Years","70 Years",{"count":71,"type":72},12,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78],"Advanced Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2025-08-18",{"date":82,"type":83},"2025-08-19","ACTUAL",{"date":85,"type":72},"2025-08-30",{"date":87,"type":72},"2027-08-30",{"name":5,"class":6},1]