[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anaplastic-thyroid-carcinomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anaplastic-thyroid-carcinomas":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100606912","phase-1-cd70-targeted-car-t-therapy-in-cd70-positive-advanced-solid-tumors-100606912",false,"NCT07181720","CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors","Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Histologically or cytologically confirmed advanced\u002Fmetastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);\n3. Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);\n4. At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:\n\n   1. Extranodal lesions with a long axis ≥10mm on CT scan;\n   2. Lymph node lesions with a short axis ≥15mm on CT scan;\n   3. CT slice thickness ≤5mm.\n5. ECOG performance status of 0-2 ;\n6. Expected survival ≥12 weeks;\n7. No history of severe psychiatric disorders;\n8. Adequate organ function as defined by the following:\n\n   1. Hematology: White blood cell count \\>2.0×10⁹\u002FL, neutrophils \\>0.8×10⁹\u002FL, lymphocytes \\>0.5×10⁹\u002FL, platelets \\>50×10⁹\u002FL, hemoglobin \\>90g\u002FL;\n   2. Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;\n   3. Renal: Serum creatinine ≤2.0×ULN;\n   4. Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);\n   5. Oxygen saturation ≥92% without supplemental oxygen;\n9. Ability to undergo single or venous blood collection, with no contraindications to cellular collection;\n10. Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;\n11. Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD70 therapies;\n2. Active\u002Fsymptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;\n3. Prior treatments within specified time frames:\n\n   1. Participation in other interventional clinical trials within 3 months before cell infusion (for unapproved drugs, the last dose must be ≥3 months prior; for approved drugs, ≥5 half-lives prior to cell infusion);\n   2. Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);\n   3. Received \\>10mg\u002Fday prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled\u002Flocal steroids (except for active autoimmune disease);\n   4. Received live attenuated vaccines within 4 weeks prior to screening;\n4. Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;\n5. History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;\n6. Cardiovascular conditions:\n\n   1. NYHA Class III or IV heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;\n   3. Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);\n   4. Severe non-ischemic cardiomyopathy;\n7. Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;\n8. Positive for HBsAg or HBcAb with elevated HBV DNA in peripheral blood; positive for HCV antibodies with detectable HCV RNA levels; positive for HIV antibodies; positive syphilis test;\n9. Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;\n10. History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:\n\n    1. Severe bleeding (grade 3 or 4) lasting for ≥30 days;\n    2. Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;\n11. Pregnant or breastfeeding women;\n12. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.",[26,27,28,29,30,31],"Renal Cell Carcinoma (RCC)","Lung Cancer","Anaplastic Thyroid Carcinomas","Ovarian Cancer","Cervical Cancer","Thymic Carcinoma","RECRUITING","2025-09-28",{"date":35,"type":36},"2025-10-02","ACTUAL",{"date":38,"type":36},"2025-09-12",{"date":40,"type":20},"2028-05-31",{"name":42,"class":43},"Chongqing Precision Biotech Co., Ltd","INDUSTRY"]