[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415017":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":180,"collaborators":20,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":20,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":20,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Juventas Cell Therapy Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single dose of CNCT19","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.",[13],"Biological: single dose of CNCT19",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","single dose of CNCT19","Dose: 0.5 x 10\\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jianxiang Wang, Dr.","Institute of Hematology & Blood Diseases Hospital, China","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yan Zhou","CONTACT","+86-15010390127","zhouyan@juventas.cn",[33,50,63,75,89,102,114,127,140,153,167],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing Boren Hospital","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":20,"phoneExt":20,"email":20},"Chunrong Tong",{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Xinqiao Hospital of TMMU","Chongqing","Chongqing Municipality","400000",{"type":42,"coordinates":56},[57,58],106.55771,29.56026,{"lat":58,"lon":57},[61],{"name":62,"role":29,"phone":20,"phoneExt":20,"email":20},"Xi Zhang",{"facility":64,"status":35,"city":65,"state":66,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Nanfang Hospital","Guangzhou","Guangdong",{"type":42,"coordinates":68},[69,70],113.25,23.11667,{"lat":70,"lon":69},[73],{"name":74,"role":29,"phone":20,"phoneExt":20,"email":20},"Hongsheng Zhou",{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":39,"countryCode":40,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Yanda hospital, Hebei medical university","NOT_YET_RECRUITING","Sanhe","Hebei","065200",{"type":42,"coordinates":82},[83,84],117.06887,39.98049,{"lat":84,"lon":83},[87],{"name":88,"role":29,"phone":20,"phoneExt":20,"email":20},"Min Jiang",{"facility":90,"status":35,"city":91,"state":92,"zip":93,"country":39,"countryCode":40,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Henan Cancer Hospital","Zhengzhou","Henan","450000",{"type":42,"coordinates":95},[96,97],113.64861,34.75778,{"lat":97,"lon":96},[100],{"name":101,"role":29,"phone":20,"phoneExt":20,"email":20},"Xudong Wei",{"facility":103,"status":35,"city":104,"state":105,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei",{"type":42,"coordinates":107},[108,109],114.26667,30.58333,{"lat":109,"lon":108},[112],{"name":113,"role":29,"phone":20,"phoneExt":20,"email":20},"Heng Mei",{"facility":115,"status":35,"city":116,"state":117,"zip":118,"country":39,"countryCode":40,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"The affiliated hospital of Xuzhou medical university","Xuzhou","Jiangsu","221006",{"type":42,"coordinates":120},[121,122],117.28386,34.20442,{"lat":122,"lon":121},[125],{"name":126,"role":29,"phone":20,"phoneExt":20,"email":20},"Kailin Xu",{"facility":128,"status":35,"city":129,"state":130,"zip":131,"country":39,"countryCode":40,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Tongji Hospital of Tongji University","Shanghai","Shanghai Municipality","200000",{"type":42,"coordinates":133},[134,135],121.45806,31.22222,{"lat":135,"lon":134},[138],{"name":139,"role":29,"phone":20,"phoneExt":20,"email":20},"Aibin Liang",{"facility":141,"status":35,"city":142,"state":143,"zip":144,"country":39,"countryCode":40,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"West China Hospital，Sichuan University","Chengdu","Sichuan","610000",{"type":42,"coordinates":146},[147,148],104.06667,30.66667,{"lat":148,"lon":147},[151],{"name":152,"role":29,"phone":20,"phoneExt":20,"email":20},"Ting Niu",{"facility":154,"status":35,"city":155,"state":156,"zip":157,"country":39,"countryCode":40,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Institute of Hematology & Blood Diseases Hospital","Tianjin","Tianjin Municipality","300020",{"type":42,"coordinates":159},[160,161],117.17667,39.14222,{"lat":161,"lon":160},[164],{"name":23,"role":29,"phone":165,"phoneExt":20,"email":166},"+86-022-23909067","wangjx@ihcams.ac.cn",{"facility":168,"status":35,"city":169,"state":170,"zip":171,"country":39,"countryCode":40,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The First Affiliated Hospital, Zhejiang University school of Medicine","Hangzhou","Zhejiang","310000",{"type":42,"coordinates":173},[174,175],120.16142,30.29365,{"lat":175,"lon":174},[178],{"name":179,"role":29,"phone":20,"phoneExt":20,"email":20},"Jie Jin",{"type":181,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100415017","phase-2-clinical-trial-of-cnct19-cell-injection-in-the-treatment-of-relapsed-or-refractory-acute-lymphoblastic-leukemia-100415017",false,"NCT04684147","Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia","Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed consent is signed by the subject.\n2. Age 18 to 65.\n3. Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).\n4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.\n5. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.\n6. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.\n7. Eastern cooperative oncology group (ECOG) performance status of 0 to 1.\n8. Adequate organ function defined as:\n\n   1. aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN);\n   2. Serum alanine aminotransferase (ALT) ≤ 3 upper limit of normal (ULN);\n   3. Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible;\n   4. A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL\u002Fmin (Cockcroft and Gault）;\n   5. Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation \\> 91% on room air;\n   6. International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.\n9. Vascular conditions for apheresis.\n10. Women of childbearing age have a negative blood \u002F urine pregnancy test within 3 days before apheresis and the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least two years after the CNCT19 infusion.\n\nExclusion Criteria:\n\n1. Active Central Nervous System (CNS) involvement by malignancy.\n2. Isolated extra-medullary disease relapse.\n3. Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:\n\n   1. Lymphodepleting Chemotherapy prescribed by the protocol;\n   2. Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped \\> 72 hours prior to CNCT19 infusion;\n   3. The following drugs must be stopped \\> 1 week prior to CNCT19 infusion: 6-mercaptopurine, 6-thioguanine, methotrexate (\\\u003C25 mg \u002F m2), cytosine arabinoside (\\\u003C100 mg \u002F m2 \u002F d), vincristine, asparaginase;\n   4. CNS prophylaxis treatment must be stopped \\> 1 week prior to CNCT19 infusion;\n   5. Pegylated-asparaginase must be stopped \\> 4 weeks prior to CNCT19 infusion.\n4. Radiotherapy before CNCT19 infusion:\n\n   Non-CNS site of radiation completed \\\u003C 2 weeks prior to CNCT19 Infusion; CNS directed radiation completed \\\u003C 8 weeks prior to CNCT19 infusion.\n5. Therapeutic systemic doses of steroids were stopped \\\u003C 72 hours prior to CNCT19 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 10 mg\u002Fday hydrocortisone or equivalent.\n6. Has received anthracycline\u002Fanthraquinone drug treatment exceeding the maximum cumulative dose recommended by the guidelines, estimated by investigators before screening, as follows:\n\n   * Doxorubicin: 550mg\u002Fm2 (radiotherapy or combined medication, \\\u003C(radiotherapy or combined medication, \\\u003C350\\~400 mg\u002Fm2);\n   * Epirubicin: 900\\~1000 mg\u002Fm2 (Adriamycin used, \\\u003C800 mg\u002Fm2);\n   * Pirarubicin: 950 mg\u002Fm2;\n   * Daunorubicin: 550 mg\u002Fm2;\n   * Demethoxydaunorubicin: 290 mg\u002Fm2;\n   * Aclarithromycin: 2000 mg\u002Fm2 (Adriamycin used, \\\u003C800 mg\u002Fm2);\n   * Mitoxantrone: 160 mg\u002Fm2 (using doxorubicin, \\\u003C120 mg\u002Fm2);\n7. Has had treatment with any prior CAR-T therapy.\n8. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening; Patients who have received systemic drug therapy for GVHD within 4 weeks before CNCT19 infusion.\n9. Patients with systemic vasculitis.\n10. Patients complying with any of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.\n11. Prior malignancy. Patients with Prior malignancy that has been cured for ≥ 5 years or has a low risk of relapse, judged by investigators are excluded.\n12. a. Left Ventricular Ejection Fraction (LVEF) ≤45%; b. III\u002FIV congestive heart failure (NYHA); c. Severe arrhythmia, or clinically significant conduction abnormalities that can be seen on ECG, including QTc interval ≥480ms (QTcB=QT\u002FRR1\u002F2); d. Hypertension that has not been controlled after standard treatment (systolic ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg); e. Unstable angina; f. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery \\\u003C 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.\n13. Clinically significant pleural effusion.\n14. Patients with a history of epilepsy, cerebrovascular ischemia \u002F hemorrhage, cerebellar disease or other active central nervous system diseases.\n15. History of deep vein thrombosis or pulmonary embolism within 6 months of screening.\n16. Known history of hypersensitivity to ingredients used in the drug.\n17. Has had treat with live vaccine within 6 weeks prior to screening.\n18. Patients with active infections in screening.\n19. Life expectancy \\\u003C 3 months.\n20. Patient in other interventional clinical studies, who received live investigational product, including: Unlisted new drugs within 3 months before CNCT19 injection, marketed drug within 5 half-lives before CNCT19 injection, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study.\n21. Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.","ALL","18 Years","65 Years",{"count":193,"type":194},100,"ESTIMATED","INTERVENTIONAL",[197],"PHASE2","The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.",[200],"Relapsed or Refractory Acute Lymphoblastic Leukemia","2025-08-06",{"date":203,"type":204},"2025-08-08","ACTUAL",{"date":206,"type":204},"2020-12-24",{"date":208,"type":194},"2026-12-31",{"name":5,"class":6},11]