[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-acute-lymphoblastic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Relapsed or Refractory Acute Lymphoblastic Leukemia","RECRUITING","2025-08-06",{"date":31,"type":32},"2025-08-08","ACTUAL",{"date":34,"type":32},"2020-12-24",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Juventas Cell Therapy Ltd.","INDUSTRY",11]