[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502867":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":21,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":21,"enrollmentInfo":76,"targetDuration":21,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","R\u002FR CD7+Malignant Hematologic Diseases",[13,14],"Drug: CD7 CAR-T cells injection","Other: Allogeneic hematopoietic stem cell transplantation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","CD7 CAR-T cells injection","CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Allogeneic hematopoietic stem cell transplantation","In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases",[9],[27],{"name":28,"affiliation":29,"role":30},"He Huang, MD","First Affiliated Hospital of Zhejiang University","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","+86-0571-87236476","hehuangyu@126.com",{"name":37,"role":33,"phone":34,"phoneExt":21,"email":38},"Yongxian HU, MD","huyongxian2000@aliyun.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.16142,30.29365,{"lat":52,"lon":51},[55,57],{"name":28,"role":33,"phone":56,"phoneExt":21,"email":35},"86-13605714822",{"name":58,"role":33,"phone":59,"phoneExt":21,"email":38},"Yongxian Hu, MD","+8615957162012",{"type":30,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"He Huang","Clinical Professor",[64],{"name":65,"class":66},"Yake Biotechnology Ltd.","INDUSTRY","100502867","phase-1-cd7-car-t-bridging-to-allohsct-for-rr-cd7malignant-hematologic-diseases-100502867",false,"NCT05827835","CD7 CAR-T Bridging to alloHSCT for R\u002FR CD7+Malignant Hematologic Diseases","A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* Male or female, older than 18 years (including 18 years)\n* Anticipated survival time more than 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML\n* Consistent with r\u002Fr CD7+acute leukemia diagnosis, including any of the following conditions\n* a. No CR after standard chemotherapy\n* b. The first induction reaches CR, but CR ≤ 12 months\n* c. Patients with r\u002Fr CD7+acute leukemia have not responded to the first or multiple remedial treatments\n* d. Multiple recurrences\n* Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments\n* Normal lung function, oxygen saturation greater than 92% without oxygen inhalation\n* The blood biochemical test results are consistent with the following results\n* a. (AST) and (ALT) ≤ 2.5 × (ULN)\n* b. Total bilirubin ≤ 1.5 × ULN\n* c. 24-hour serum creatinine clearance ≥ 30 mL\u002Fmin\n* d. Lipase and amylase ≤ 2 × ULN\n* Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening\n\nExclusion Criteria:\n\n* Patients with the history of epilepsy or other CNS disease\n* Pregnant or breastfeeding\n* Active infection with no cure\n* Patients with prolonged QT interval time or severe heart disease\n* Have experienced hypersensitivity or intolerance to any drug used in this study\n* Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening\n* Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening\n* Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis\n* In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs\n* Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding\u002Fcoagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding\n* Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study\n* Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1\u002F2) before screening\n* Any situation that the researchers believe may increase the risk of patients or interfere with the test results.","ALL","18 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","This is a single-arm, open-label, single-center, phase I\u002FII study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases",[85,86],"Hematologic Diseases","Neoplasms",[88,89],"allo-HSCT","CD7 CAR-T","2025-08-07",{"date":92,"type":93},"2025-08-13","ACTUAL",{"date":95,"type":93},"2023-04-30",{"date":97,"type":78},"2027-04-25",{"name":5,"class":6},1]