[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601706":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":11,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":11,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL",null,[13],"Biological: CAR-T(CD70)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","CAR-T(CD70)","In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be administered intratumorally under CT guidance at the pre-specified dose. Following treatment, the efficacy and safety of CD70-directed CAR-T-cell therapy will be comprehensively assessed through clinical symptom evaluations, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Wei Guan","Professor","100601706","early-phase-1-clinical-study-of-a-novel-humanized-cd70-targeted-car-t-cell-incorporating-tlr2-for-advanced-renal-cell-carcinoma-therapy-100601706",false,"NCT07113977","Clinical Study of a Novel Humanized CD70-Targeted CAR-T Cell Incorporating TLR2 for Advanced Renal Cell Carcinoma Therapy","Inclusion Criteria:\n\n* 1\\. Voluntary participation with written informed consent provided by the patient or legally authorized representative;\n* 2.Age 18-75 years (inclusive) at the time of consent, regardless of sex;\n* 3.Advanced-stage renal cell carcinoma (RCC) with no curative treatment options, who have received ≥1 prior line of therapy and meet one or more of the following:\n\n  1. Recurrence after first-line or later-line treatment(s).\n  2. Progression or persistent progression following prior therapy;\n* 4.Histopathologically confirmed advanced RCC per WHO 2016 classification, with at least one measurable lesion evaluable by CT or MRI;\n* 5.CD70 positivity in tumor tissue confirmed by immunohistochemistry (IHC);\n* 6.Adequate organ function: Hepatic: ALT\u002FAST \\\u003C3× ULN and total bilirubin ≤34.2 μmol\u002FL. Renal: Creatinine clearance (Cockcroft-Gault) ≥60 mL\u002Fmin. Pulmonary: Oxygen saturation ≥95% with no active pulmonary infection. Cardiac: LVEF ≥50%, no significant pericardial effusion, and no clinically relevant ECG abnormalities;\n* 7.Contraception: Women of childbearing potential must have a negative pregnancy test (urine\u002Fserum) at screening and agree to use effective contraception for ≥1 year post-infusion.\n\nMen with partners of childbearing potential must use barrier contraception for ≥1 year post-infusion;\n\n* 8.Performance status: ECOG score 0-3;\n* 9.Life expectancy \\>3 months;\n* 10.Willingness to comply with leukapheresis, medical assessments, and follow-up visits.\n\nExclusion Criteria:\n\n* 1.Pregnant or lactating women;\n* 2.Uncontrolled fungal, bacterial, Treponema pallidum, viral, or other infections;\n* 3.Active hepatitis: HBV DNA \\>500 IU\u002FmL. Positive HCV RNA (confirmed by repeat testing);\n* 4.HIV infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection;\n* 5.Prior gene therapy of any form;\n* 6.History of severe allergic reactions to biologics (including antibiotics), antibodies, cytokines, or other macromolecular agents;\n* 7.Clinically significant CNS disorders: epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome;\n* 8.Uncontrolled psychiatric illness;\n* 9.Substance abuse\u002Faddiction;\n* 10.Prohibited medications\u002Ftreatments: Corticosteroids: ≥2 mg\u002Fkg prednisone (or equivalent \\>20 mg\u002Fday) within 2 weeks before leukapheresis.\n\nChemo\u002Fradiotherapy: Anti-tumor radiotherapy or salvage chemotherapy within 3 weeks before leukapheresis.\n\nImmunosuppressants: Use within 4 weeks before leukapheresis. Other trials\u002Fmajor surgery: Participation in another clinical trial or major non-diagnostic surgery within 4 weeks before leukapheresis.\n\nSpecific agents: Alemtuzumab within 6 months, or clofarabine\u002Fcladribine within 3 months before leukapheresis.","ALL","18 Years","75 Years",{"count":34,"type":35},30,"ESTIMATED","INTERVENTIONAL",[38],"EARLY_PHASE1","In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be infused at the pre-specified dose. Post-infusion, the efficacy and safety of CD70-directed CAR-T-cell therapy will be systematically evaluated using clinical symptom assessments, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.",[41],"Advanced Renal Cell Carcinoma",[43,44,45],"CD70","CAR-T","Advanced renal cell carcinoma","NOT_YET_RECRUITING","2025-08-07",{"date":49,"type":50},"2025-08-11","ACTUAL",{"date":52,"type":35},"2025-08-15",{"date":54,"type":35},"2028-12-31",{"name":22,"class":6}]