[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100646139","early-phase-1-clinical-study-on-the-safety-and-efficacy-of-pid23-injection-in-patients-with-relapsedrefractory-acute-leukemia-100646139",false,"NCT07696481","Clinical Study on the Safety and Efficacy of PID23 Injection in Patients With Relapsed\u002FRefractory Acute Leukemia","A Single-center, Single-arm, Open-label Clinical Study on the Safety and Efficacy of PID23 Injection in Treating Patients With Relapsed\u002FRefractory Acute Leukemia","R\u002FR AL","Inclusion Criteria:\n\n1. Patient or legal guardian voluntarily signs the informed consent form (ICF), demonstrating understanding of the study purpose and procedures, and willingness to participate.\n2. Age 3 to 75 years, inclusive, male or female.\n3. Diagnosis of relapsed or refractory acute leukemia per guideline criteria:\n\nRelapsed: reappearance of leukemic cells in peripheral blood or bone marrow blasts ≥5% after achieving complete remission (CR); Refractory: failure to achieve CR after 2 courses of standard induction chemotherapy; relapse within 12 months after consolidation\u002Fintensification therapy; relapse after 12 months with no response to conventional chemotherapy; 2 or more relapses; extramedullary leukemia relapse or persistence; relapse after allogeneic hematopoietic stem cell transplantation.\n\n4.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 5.Life expectancy ≥12 weeks. 6.Bone marrow morphology showing ≥5% primitive\u002Fimmature lymphocytes (blasts). 7.Tumor cells positive for CD19, BCMA, or CD70 expression by flow cytometry. 8.Adequate major organ function, defined as:\n\n1. Cardiac: left ventricular ejection fraction (LVEF) ≥40% by echocardiogram;\n2. Renal: serum creatinine ≤2.0× upper limit of normal (ULN), or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula);\n3. Hepatic: ALT and AST ≤3.0×ULN (≤5.0×ULN if with liver involvement); total bilirubin ≤2.0×ULN (≤3.0×ULN for Gilbert's syndrome);\n4. Pulmonary: oxygen saturation ≥92% on room air;\n5. Hematologic: absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, platelets ≥50×10⁹\u002FL, hemoglobin ≥80 g\u002FL (with bone marrow involvement, ANC ≥0.5×10⁹\u002FL, platelets ≥20×10⁹\u002FL permitted) - assessments allowed after transfusion or hematopoietic growth factor support.\n\n9\\. For women of childbearing potential, negative serum pregnancy test; all participants agree to use reliable (non-rhythm) contraceptive methods from ICF signing through 1 year post-PID23 infusion.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T or other genetically modified cell therapies, unless the investigator determines that safety risks have been adequately excluded.\n2. Received the following anti-tumor therapies prior to PID23 infusion: Chemotherapy or molecular targeted therapy within 14 days or 5 half-lives (whichever is longer) (excluding conditioning chemotherapy and intrathecal chemotherapy; intrathecal therapy must be stopped ≥1 week prior to PID23 infusion); Radiotherapy to non-hematopoietic sites within 7 days; Radiotherapy to hematopoietic sites within 14 days.\n3. Any of the following cardiac conditions:\n\n(1) New York Heart Association (NYHA) Class III or IV congestive heart failure; (2) Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment; (3) Clinically significant ventricular arrhythmia, or unexplained syncope (excluding vasovagal or dehydration-related); (3) History of severe non-ischemic cardiomyopathy. 4.Active or uncontrolled infection requiring systemic therapy within 1 week prior to screening.\n\n5.Grade 2-4 acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks prior to screening.\n\n6.Cerebrovascular accident or seizure within 6 months prior to screening. 7.Deep vein or arterial thrombosis event within 6 months prior to screening. 8.Active malignancy other than acute leukemia (excluding: inactive disease with treatment completed \\>2 years; adequately treated cervical carcinoma in situ, basal\u002Fsquamous cell skin carcinoma, localized prostate cancer post-curative surgery, ductal carcinoma in situ post-curative surgery).\n\n9.Received (attenuated) live vaccine within 4 weeks prior to screening. 10.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.","ALL","3 Years","75 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","Relapsed or refractory acute leukemia (R\u002FR AL) is a life-threatening blood cancer with poor outcomes and limited treatment options. PID23 Injection is an innovative in vivo CAR-T therapy that delivers a viral vector encoding three targets (CD19, BCMA, and CD70) directly into patients, enabling their own T cells to generate functional CAR-T cells against leukemia cells. This single-center, single-arm, open-label, dose-escalation study (3 dose levels: 0.8×10⁹, 2×10⁹, and 4×10⁹ TU) plans to enroll 3-18 patients with R\u002FR AL aged 3-75 years, ECOG 0-2, and positive for at least one target. The primary objective is to evaluate safety, tolerability, and determine the recommended dose. Secondary objectives include preliminary efficacy (remission, survival), pharmacokinetics (CAR-T expansion), pharmacodynamics (cytokine changes), and exploratory viral clearance. After a single intravenous infusion, patients are hospitalized for ≥3 weeks, followed by monthly visits for 3 months, then every 3 months for up to 2 years. Enrollment is from May 2026 to May 2027, with follow-up through May 2029. The study is conducted at Zhujiang Hospital of Southern Medical University (PI: Prof. Li Yuhua).",[28,29,30],"Relapsed or Refractory Acute Leukemia","Relapsed or Refractory Acute Lymphoblastic Leukemia","Relapsed or Refractory Acute Myeloid Leukemia (AML)",[32,33,34,35,36,37,38,39,40],"PID23","In vivo CAR-T","Acute Leukemia","Relapsed","Refractory","AML","B-ALL","Acute Myeloid Leukemia","Acute lymphoblastic leukemia","NOT_YET_RECRUITING","2026-07-09",{"date":44,"type":45},"2026-07-10","ACTUAL",{"date":47,"type":22},"2026-08-01",{"date":49,"type":22},"2030-03-31",{"name":51,"class":52},"Zhujiang Hospital","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100415017","phase-2-clinical-trial-of-cnct19-cell-injection-in-the-treatment-of-relapsed-or-refractory-acute-lymphoblastic-leukemia-100415017","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.","18 Years","65 Years",{"count":64,"type":22},100,[66],"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.",[29],"RECRUITING","2025-08-06",{"date":72,"type":45},"2025-08-08",{"date":74,"type":45},"2020-12-24",{"date":76,"type":22},"2026-12-31",{"name":78,"class":79},"Juventas Cell Therapy Ltd.","INDUSTRY",11]