[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527822":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":23,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":23,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":23,"overallStatus":53,"whyStopped":23,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"BioSyngen Pte Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BGT007H injection","EXPERIMENTAL","Intravenous infusion",[13,14,15,16],"Biological: First dose","Biological: Second dose","Biological: The third dose","Biological: The fourth dose",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","First dose","1.0×10\\^8cells,Intravenous infusion，1 subject is planned to be enrolled",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Second dose","3.0×10\\^8cells,Intravenous infusion，3 subject is planned to be enrolled",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"The third dose","1.0×10\\^9cells,Intravenous infusion，3 subject is planned to be enrolled",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"The fourth dose","3.0×10\\^9cells,Intravenous infusion，3 subject is planned to be enrolled",[9],[37],{"name":38,"affiliation":39,"role":40},"Yi Zhang","The First Affiliated Hospital of Zhengzhou University","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Xinfeng Chen","CONTACT","0371-66295320","fengxinchen1985@163.com",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},"Dan Wang","13383812031","wang.dan1002@163.com",[52],{"facility":39,"status":53,"city":54,"state":55,"zip":23,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Zhengzhou","Henan","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.64861,34.75778,{"lat":62,"lon":61},[65,66],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":23,"email":67},"dan.wang1002@163.com",{"type":69,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[71],{"name":39,"class":72},"OTHER","100527822","early-phase-1-bgt007h-cells-for-the-treatment-of-recurrentrefractory-gastrointestinal-tumors-100527822",false,"NCT06152757","BGT007H Cells for the Treatment of Recurrent\u002FRefractory Gastrointestinal Tumors","Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent\u002FRefractory Gastrointestinal Tumors","Inclusion Criteria:\n\n* 1\\. Resources sign written informed consent;\n* 2, age ≥18, male and female can;\n* 3\\. Expected survival ≥3 months;\n* 4\\. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;\n* 5\\. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;\n* 6\\. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;\n* 7\\. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology\u002Fcytology as having failed the standard of second-line or above treatment or are not suitable for\u002Frefuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);\n* 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;\n* 9, with adequate organ and bone marrow function;\n* 10\\. 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\n* 1\\. Active central nervous system metastasis (except stable after treatment);\n* 2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive;\n* 3, mental or mental illness can not cooperate with treatment and efficacy evaluation;\n* 4\\. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n* 5\\. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;\n* 6\\. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100mmHg);\n* 7, combined with lung, brain, kidney and other important organ dysfunction;\n* 8\\. 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;\n* 9\\. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;\n* 10\\. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;\n* 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;\n* 12\\. Combined graft-versus-host disease (GVHD)\n* 13\\. Subjects 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 hours prior to cell transfusion (except for inhalation or topical use);\n* 14\\. Severe allergy or history of allergy;\n* 15\\. Subjects requiring anticoagulation therapy;\n* 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;\n* 17\\. Researchers believe that there are other reasons for not being included in the treatment.","ALL","18 Years",{"count":83,"type":84},14,"ESTIMATED","INTERVENTIONAL",[87],"EARLY_PHASE1","This study is an exploratory single-arm, open, modified \"3+3\" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent\u002Frefractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.\n\nFour dose levels were designed for this study: 1.0×10\\^8cells, 3.0×10\\^8cells, 1.0×10\\^9cells, and 3.0×10\\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent\u002Frefractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.",[90],"Gastrointestinal Tumors","2023-11-22",{"date":93,"type":94},"2023-12-01","ACTUAL",{"date":96,"type":94},"2023-10-09",{"date":98,"type":84},"2027-07-19",{"name":5,"class":6},1]