[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572048":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-NKT Cells Lymphodepleting regimen","EXPERIMENTAL","Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg\u002Fm2 IV on day -5 to -3 and Fludarabine 25mg\u002Fm2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0.",[13],"Biological: CAR-NKT Cells treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CAR-NKT Cells treatment","Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg\u002Fm2 IV on day -5 to -3 and Fludarabine 25mg\u002Fm2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0.\n\nPotential CGC738 doses:\n\nDose level 1: 5.0×106 CAR- NKT cells\u002Fm2; Dose level 2: 1.5×107 CAR- NKT cells\u002Fm2; Dose level 3: 4.5×107 CAR- NKT cells\u002Fm2;",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xinan Sheng Professor, MD","CONTACT","+86-10-88196348","doctor_sheng@126.com",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Beijing Cancer Hospital","RECRUITING","Beijing","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":26},"Xinan Sheng, Professor","86-13810335676",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jun Guo","Deputy Director of Peking University Cancer Hospital & Institute；Director of Renal Cancer and Melanoma Department.",[49],{"name":50,"class":51},"Suzhou Cure Genetics Biosciences Co., Limited.","UNKNOWN","100572048","phase-1-a-clinical-research-about-cd70-targeted-car-nkt-cells-therapy-in-subjects-with-advanced-malignant-solid-tumors-100572048",false,"NCT06728189","A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors","A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 75 years.\n2. ECOG 0-1 points.\n3. The expected survival time is more than 3 months.\n4. Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.\n5. IHC: CD70 positive.\n6. At least one measurable lesion at baseline per RECIST version 1.1.\n7. The functions of important organs are basically normal:\n8. Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.\n9. Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. Use of cell therapy within the previous one month.\n2. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.\n3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.\n4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.\n5. Active hepatitis B, HIV positive and HCV positive.\n6. Active infection or uncontrollable infection.\n7. Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.\n8. Unstable respiratory diseases, including interstitial pneumonia.\n9. Uncontrolled ascites and pleural effusion\n10. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .\n11. Subjects who are using systemic steroids or steroid inhalers for treatment.\n12. Pregnant or lactating female subjects.\n13. Other investigators deem it unsuitable to participate in the study.","ALL","18 Years","75 Years",{"count":63,"type":64},13,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors.\n\nCondition or disease：advanced malignant solid tumors Intervention\u002Ftreatment：Biological: CD70 CAR-NKT cells Phase：Phase 1",[70],"Advanced Malignant Solid Tumors","2024-12-10",{"date":73,"type":74},"2024-12-11","ACTUAL",{"date":76,"type":74},"2024-11-14",{"date":78,"type":64},"2026-10-17",{"name":5,"class":6},1]