[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646139":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":84,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PID23 Injection (Dose Escalation)","EXPERIMENTAL","Participants receive a single intravenous infusion of PID23 Injection at one of three dose levels (0.8×10⁹, 2×10⁹, or 4×10⁹ TU) according to a rapid titration + standard 3+3 dose-escalation design. The starting dose is 0.8×10⁹ TU, with escalation to higher dose levels guided by safety and pharmacokinetic assessments. All subjects are hospitalized for observation for at least 3 weeks post-infusion and followed for up to 2 years.",[13],"Biological: PID23 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","PID23 Injection","PID23 is an in vivo CAR-T product, a lentiviral vector encoding CD19, BCMA, and CD70 chimeric antigen receptors, administered as a single intravenous infusion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yuhua Li, PhD","CONTACT","+86-020-61643188","liyuhua2011gz@163.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Department of Hematology, Zhujiang Hospital, Southern Medical University","Guangzhou","Guangdong","510282","China","CN",{"type":36,"coordinates":37},"Point",[38,39],113.25,23.11667,{"lat":39,"lon":38},[42,44],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"+86-020-62782316",{"name":20,"role":24,"phone":20,"phoneExt":20,"email":45},"zhoulijanice@foxmail.com",{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[49],{"name":50,"class":51},"Chongqing Precision Biotech Co., Ltd","INDUSTRY","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":64,"type":65},18,"ESTIMATED","INTERVENTIONAL",[68],"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).",[71,72,73],"Relapsed or Refractory Acute Leukemia","Relapsed or Refractory Acute Lymphoblastic Leukemia","Relapsed or Refractory Acute Myeloid Leukemia (AML)",[75,76,77,78,79,80,81,82,83],"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":87,"type":88},"2026-07-10","ACTUAL",{"date":90,"type":65},"2026-08-01",{"date":92,"type":65},"2030-03-31",{"name":5,"class":6},1]