[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524092":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":23,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"The Affiliated Hospital of Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BGT007H Cell Injection","EXPERIMENTAL","This is an exploratory study of single-arm, open, modified \"3+3\" dose escalation. The BGT007H cell therapy group received five progressively increased dose levels (2.0× 10\\^8,5.0 ×10\\^8, 1.0× 10\\^9,3.0 × 10\\^9,6.0 ×10\\^9) of BGT007H cells. Each subject was observed for at least 4 weeks after cell transfusion (DLT observation period). The first two dose groups (2.0×10\\^8 cells and 5.0×10\\^8 cells) included 1 subject each, and the other three dose groups were followed by conventional \"3+3\" dose increments.",[13],"Biological: BGT007H Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BGT007H Injection","BGT007H injection (d0) were infused intravenously once, and the dose group was 2.0× 10\\^8 cells,5.0 ×10\\^8 cells, 1.0× 10\\^9 cells,3.0 × 10\\^9 cells,6.0 ×10\\^9 cells.",[9],null,[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Xuzhou","Jiangsu","221000","China","CN",{"type":30,"coordinates":31},"Point",[32,33],117.28386,34.20442,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Li Li, doctor","CONTACT","+86-516-85609999","lily9711214@126.com",{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[44],{"name":45,"class":46},"Guangzhou Bioresette Biomedical Technology Co., Ltd.","INDUSTRY","100524092","early-phase-1-bgt007h-cells-for-the-treatment-of-refractory-digestive-system-tumors-100524092",false,"NCT06104215","BGT007H Cells for the Treatment of Refractory Digestive System Tumors","Clinical Study on the Safety and Initial Efficacy of BGT007H Cell Therapy in Patients With Recurrent\u002FMetastatic Refractory Digestive Tract Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent;\n2. Age ≥18 years old, ≤70 years old, male and female;\n3. Expected survival ≥ 3 months;\n4. The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1;\n5. Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent) : Target protein test is positive;\n6. At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria;\n7. Patients with recurrent\u002Fmetastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance;\n8. It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation;\n9. having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10\\^9\u002FL Platelet count (PLT) ≥80×10\\^9\u002FL Hemoglobin concentration ≥90g\u002FL Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL\u002Fmin Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN\n10. Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);\n11. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result is negative.\n\nExclusion Criteria:\n\n1. Active central nervous system metastases (except those stable after treatment);\n2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive;\n3. Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;\n4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n5. Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment;\n6. Any unstable systemic disease (including but not limited to) :\n\n   Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100 mmHg);\n7. dysfunction of important organs such as lung, brain and kidney;\n8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;\n9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to anapheresis or within 5 half-lives, whichever is shorter;\n10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years;\n11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months;\n12. Graft-versus-host disease (GVHD);\n13. Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use);\n14. Severe allergies or history of allergies;\n15. Subjects requiring anticoagulation therapy;\n16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)\n17. Researchers believe that there are other reasons for not being included in the treatment.","ALL","18 Years","70 Years",{"count":58,"type":59},14,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007H injection in the treatment of recurrent\u002Fmetastatic\u002Frefractory digestive system tumors.",[65],"Digestive Tract Cancer",[67],"recurrent\u002Fmetastatic\u002Frefractory","2023-10-23",{"date":70,"type":71},"2023-10-27","ACTUAL",{"date":73,"type":71},"2023-10-22",{"date":75,"type":59},"2027-10-20",{"name":5,"class":6},1]