[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-pediatric-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-pediatric-all":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100612733","phase-1-cd45ra-depleted-cd19-car-t-cell-consolidation-after-tcrcd19-b-cell-depleted-haploidentical-hematopoietic-cell-transplantation-for-relapsedrefractory-cd19-all-and-lymphoma-100612733",false,"NCT07257419","CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+\u002FCD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed\u002FRefractory CD19+ ALL and Lymphoma","Inclusion Criteria:\n\nRecipient\n\n* Age less than or equal to 21 years\n* High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):\n\n  * High risk CD19+ B cell ALL in CR1 or CR2\n  * Any CD19+ B-cell ALL in CR3 or subsequent\n* If prior CNS leukemia, it must be treated and in CNS CR\n* Left ventricular ejection fraction \\> 40%, or shortening fraction ≥ 25%\n* Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73m2\n* Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing\n* Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)\n* Bilirubin ≤ 3 times the upper limit of normal for age\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age\n\nDonor\n\n* At least single haplotype matched (≥ 4 of 8) family member\n* At least 18 years of age\n* HIV negative\n* If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure\n* Regarding donation eligibility, is identified as either:\n\n  * Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR\n  * Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271\n\nExclusion Criteria:\n\nRecipient\n\n* Has a suitable HLA-identical sibling or suitable 12\u002F12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame\n* Any other active malignancy other than the one for which this HCT is indicated\n* Received a prior allogeneic HCT at any time\n* Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment\n* If sexually active, agreement to use birth control until 6 months after T cell infusion\n* Breast feeding\n* Any severe current uncontrolled bacterial, fungal or viral infection\n\nDonor\n\n* Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female\n* If female, breast feeding","ALL","21 Years",{"count":18,"type":19},70,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.\n\nPrimary Objective:\n\n\\- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+\u002FCD19 depleted haploidentical donor transplantation for pediatric patients with relapsed\u002Frefractory CD19+ B-cell malignancies.\n\nSecondary Objectives:\n\n* To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS).\n* To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.",[25,26,27],"Relapsed Pediatric ALL","Hematopoietic Cell Transplantation","Hematologic Malignancy",[29],"Relapsed\u002FRefractory ALL","RECRUITING","2026-05-18",{"date":33,"type":34},"2026-05-19","ACTUAL",{"date":36,"type":19},"2026-06-03",{"date":38,"type":19},"2035-12",{"name":40,"class":41},"St. Jude Children's Research Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100357817","phase-1-anti-cd19-dual-co-stimulatory-4-1bb-cd3-chimeric-antigen-receptor-t-cells-in-patients-with-relapsedrefractory-aggressive-lymphoma-or-acute-lymphoblastic-leukemia-all-100357817","NCT03938987","Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed\u002FRefractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)","A Phase 1b\u002F2 Multi-center, De-centralized, Dose Selection Study of Autologous CD19-directed Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed\u002FRefractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)","ACIT001\u002FEXC002","Inclusion Criteria:\n\n1. Have given written informed consent prior to any study-specific procedures; children (defined as 17 years of age or less) require guardian consent.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; or Karnofsky \\> 50%.\n3. Age of 2 to 70 years at time of screening.\n4. A histologically or cytologically documented, CD19+ non-hodgkin's lymphoma or ALL.\n5. At least 1 measurable lesion or FDG-avid disease by positron-emission tomography\u002Fcomputed tomography (PET\u002FCT) for lymphoma patients; quantifiable evidence of ALL in either peripheral blood or bone marrow aspirate.\n6. Tumor tissue (archival or recent acquisition) must be available for correlative laboratory studies (such as immunohistochemistry, and others).\n7. At least 2 prior systemic therapies and patient must not be eligible for potentially curative standard-of-care therapy.\n8. Adequate renal function (defined as Cockroft-Gault creatinine clearance \\> 50 mL\u002Fmin) and hepatic function (total bilirubin \\\u003C 1.5x ULN; and AST\u002FALT \\\u003C 3x ULN) unless directly related to malignant disease being treated for on study as demonstrated either by PET\u002FCT imaging or by biopsy and histopathologic confirmation.\n9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n10. Male participants should agree to not donate sperm during study period (i.e. up to 2 years following CAR T-cell administration).\n11. Male participants with reproductive potential must agree to use medical approved contraceptives during the study and for 90 days following the last dose of study treatment.\n12. Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyte globulin \\[ATG\\]), CD19-directed antibody-based therapies (except blinatumomab), or other gene therapy products.\n2. Received any investigational drug\u002Fanti-cancer therapy within 30 days.\n3. Concurrent participation in another therapeutic clinical trial.\n4. Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days prior to blood collection for CAR T-cell product manufacture.\n5. Donor lymphocyte infusion (DLI) within 4 weeks prior to leukapheresis.\n6. Salvage or debulking chemotherapy within 1 week prior to blood collection for CAR T-cell product manufacture.\n7. Prior central nervous system (CNS) involvement.\n8. Unresolved acute toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade \\>1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other nonacute toxicities are acceptable.\n9. An uncontrolled intercurrent illness including but not limited to ongoing or active infection (including fever within 48 hours of screening), symptomatic congestive heart failure (i.e., New York Heart Association \\[NYHA\\] Class 3 or 4), unstable angina pectoris, clinically significant and uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Major surgical procedure within 30 days.\n11. Known history of human immunodeficiency virus (HIV) or active infection requiring therapy, or positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA).\n12. Any vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks (28 days) of initiation of study treatment.\n13. A woman who is pregnant or breastfeeding.","2 Years","70 Years",{"count":54,"type":19},63,[22,56],"PHASE2","Autologous, unselected CD3+ lymphocytes collected from apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ).",[59,60,25],"Relapsed Non Hodgkin Lymphoma","Relapsed Adult ALL","2026-02-04",{"date":63,"type":34},"2026-02-09",{"date":65,"type":34},"2021-03-03",{"date":67,"type":19},"2027-12",{"name":69,"class":41},"University of Alberta",6,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"100560740","bridging-allogeneic-hematopoietic-stem-cell-transplantation-or-not-after-cd19-car---t-s1904-cell-therapy-for-rr-b-cell-acute-lymphoblastic-leukemia-100560740","NCT06581081","Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r\u002Fr B-cell Acute Lymphoblastic Leukemia","Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r\u002Fr B-cell Acute Lymphoblastic Leukemia, a Prospective, Open, Multicenter, Randomized, Control Study (COMPLETE Study)","Inclusion Criteria:\n\n1. The subject or guardian understands and voluntarily signs the Informed Consent Form (ICF);\n2. Male or female, aged 12-65 years (including the cutoff value) when signing the informed consent form;\n3. Expected survival period is not less than 12 weeks;\n4. ECOG physical performance score is 0-1 when signing the ICF;\n5. The subject must be diagnosed with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia when signing the ICF, and at least one of the following must be met:\n\n   1. Relapse: including relapse within 12 months after the first remission, 2 or more relapses;\n   2. Refractory: including primary refractory, failure to achieve remission after at least 2 courses of induction therapy, or failure to achieve remission after at least 1 course of salvage therapy after the first relapse.\n6. For patients with Philadelphia chromosome-positive ALL (Ph+ ALL), in addition to meeting the above relapse or refractory criteria, they should have failed at least two tyrosine kinase inhibitor (TKI) treatments (except for those with T315I mutations), or be unable to tolerate TKI treatment, or have contraindications to TKI treatment;\n7. Bone marrow morphology examination at screening showed that the proportion of primitive immature lymphocytes in the bone marrow was \\>5%;\n8. Tumor cells in the bone marrow or peripheral blood were CD19 positive by flow cytometry at screening;\n9. Major organ functions must meet the following requirements:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN);\n   2. Total bilirubin ≤2×ULN;\n   3. Serum creatinine clearance of adult subjects ≥60 mL\u002Fmin (Cockcroft-Gault formula) or creatinine ≤1.5×upper limit of normal (ULN);\n   4. Serum creatinine for children: no more than 1.2 mg\u002FdL for 10 to 13 years old, no more than 1.5 mg\u002FdL for males aged 13 to 16 years old, no more than 1.4 mg\u002FdL for females aged 13 years and above, and no more than 1.7 mg\u002FdL for males aged 16 years and above.\n10. Blood oxygen saturation\\>92%;\n11. Males and females of childbearing age with fertility must agree to use effective contraceptive measures from the signing of the informed consent form until 2 years after the use of the study drug. Females of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of females of childbearing age must be negative at the time of screening.\n\nExclusion Criteria:\n\n1. Isolated extramedullary relapse;\n2. Burkitt's lymphoma\u002Fleukemia;\n3. Previous history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy (except inactive CNS leukemia);\n4. Previous hematopoietic stem cell transplantation;\n5. History of autoimmune disease requiring systemic immunosuppressive drug treatment within 2 years before signing the ICF (including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, inflammatory bowel disease, vasculitis, psoriasis);\n6. Any uncontrolled active infection at the time of signing the ICF or within 4 weeks before apheresis, requiring antibiotic, antiviral or antifungal treatment;\n7. Previous cell therapy targeting CD19 (autologous or allogeneic);\n8. Received CAR-T therapy or other cell\u002Fgene therapy before screening;\n9. Those who tested positive for hepatitis B surface antigen (HBsAg) during screening need to be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, those with peripheral blood hepatitis B virus (HBV) DNA above the detection limit need to be excluded; those who tested positive for hepatitis C virus (HCV) antibody and HCV RNA need to be excluded; those who tested positive for human immunodeficiency virus (HIV) antibody; those who tested positive for cytomegalovirus (CMV) DNA; those who tested positive for human lymphotropic herpes virus (EBV) DNA; those who tested positive for both Treponema pallidum-specific and non-specific antibodies;\n10. Clinically significant cardiovascular disease, including any of the following:\n\n    1. QTc interval ≥470 ms after heart rate correction (QTc interval calculated by Fridericia formula);\n    2. New York Heart Association (NYHA) grade II or above heart failure;\n    3. Unstable angina or acute myocardial infarction within 6 months before signing the ICF;\n    4. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    5. Poorly controlled hypertension (systolic blood pressure ≥ 150 mm Hg and\u002For diastolic blood pressure ≥ 95 mm Hg);\n    6. Arrhythmias with clinical significance or requiring antiarrhythmic treatment (such as sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes tachycardia and complete left bundle branch block, etc.);\n11. Allergic to any drug component to be used in this study, including but not limited to S1904, clearing drugs (cyclophosphamide, fludarabine), etc.;\n12. Received any study drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is more appropriate as determined by the researcher);\n13. Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy of non-target lesions for symptom relief within 2 weeks before signing the ICF or expected during the study period;\n14. At the time of signing the ICF, except for alopecia and pigmentation, the toxicity caused by previous anti-tumor treatment has not recovered to grade 1 or baseline level (according to NCI-CTCAE version 5.0);\n15. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than 10 mg\u002Fday of prednisone) or other immunosuppressive drugs within 2 weeks before signing the ICF or within 2 weeks before apheresis or during the study, except for the following:\n\n    1. Intranasal, inhaled, local steroids or local steroid injections (such as intra-articular injections), or\n    2. Systemic corticosteroid treatment not exceeding 10 mg\u002Fday of prednisone or its equivalent physiological dose, or\n    3. Steroids as a preventive medication for allergic reactions (such as pretreatment before computed tomography \\[CT\\]), or\n    4. Used for symptomatic treatment of adverse reactions after reinfusion;\n16. Subjects who have undergone major surgery (except routine biopsy) within 4 weeks before signing the ICF, or are expected to undergo major surgery during the study;\n17. Subjects with a history of active tuberculosis infection within 1 year before signing the ICF (except for subjects with a history of active tuberculosis infection more than 1 year ago who are judged by the investigator to have no evidence of active tuberculosis);\n18. Subjects with clinically significant thyroid dysfunction as judged by the investigator;\n19. Subjects with or with a history of interstitial lung disease or interstitial pneumonia;\n20. Subjects with a history of other primary malignant tumors within 5 years before signing the ICF, except for the following:\n\n    1. Cervical carcinoma in situ that has been fully treated and cured;\n    2. Localized basal cell carcinoma or squamous cell carcinoma of the skin;\n21. Subjects who have received attenuated\u002Finactivated vaccines within 4 weeks before signing the ICF, or subjects who are planned to receive attenuated\u002Finactivated vaccines during the screening period;\n22. The researcher believes that the subject's complications or other conditions may affect compliance with the protocol or may be unsuitable for participation in this study;\n23. Pregnancy or lactation.","12 Years","65 Years",{"count":81,"type":19},130,[83],"NA","Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory (R\u002FR) B-cell acute lymphoblastic leukemia (B-ALL). Targeted CD19 CAR-T cell immunotherapy is an effective means of treating R\u002FR B-ALL. Several clinical studies have shown that its remission rate for R\u002FR B-ALL can reach 68-93%. However, long-term follow-up found that the remission time after CD19 CAR-T treatment is short and the relapse rate is high. Therefore, how to ensure the long-term survival of R\u002FR B-ALL patients after remission by CAR-T therapy is an urgent problem to be solved. Some studies have shown that timely bridging allo-HSCT after CAR-T treatment can overcome the risk of relapse and further improve the long-term survival of patients. However, there is currently no randomized controlled study on whether to bridge transplantation after CAR-T. The purpose of this study is to evaluate the efficacy and safety of S1904 in the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia with or without bridging to allogeneic hematopoietic stem cell transplantation after remission.",[60,86,87,25],"B-cell Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia","2025-03-08",{"date":90,"type":34},"2025-03-12",{"date":92,"type":34},"2024-10-01",{"date":94,"type":19},"2029-08-31",{"name":96,"class":41},"Peking University People's Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":104,"maxAge":16,"enrollmentInfo":105,"targetDuration":4,"studyType":20,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100464986","phase-2-a-study-of-pcar-19b-in-the-treatment-of-cd19-positive-relapsedrefractory-b-all-in-children-and-adolescents-100464986","NCT05334823","A Study of pCAR-19B in the Treatment of CD19-positive Relapsed\u002FRefractory B-ALL in Children and Adolescents","A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed\u002FRefractory B-ALL","Inclusion Criteria:\n\n1. The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research;\n2. Diagnosed with B-ALL，and meet one of the following conditions:\n\n   1. Refractory B-ALL: early-stage refractory patients who failed to achieve complete remission after 2 courses of standard induction chemotherapy;\n   2. Relapsed B-ALL: patients with early relapse (\\\u003C12 months) after complete remission;or late relapse (≥12 months) after complete remission, and relapsed patients who have not achieved complete remission after standard treatment or have poor response to early treatment; experience Patients with 2 or more bone marrow recurrences; patients with recurrence after allogeneic hematopoietic stem cell transplantation;\n   3. For Ph+ALL patients, patients who have not achieved complete remission after receiving at least two Tyrosine kinase inhibitors (TKI) treatments or have relapsed after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment or have T315i mutation resistance to TKI drugs);\n3. The malignant cells in the bone marrow were confirmed to express CD19 by flow cytometry;\n4. Bone marrow morphology at the time of screening indicated that blasts≥ 5%;\n5. Eastern Cooperative Oncology Group (ECOG) 0-1 points ;\n6. Expected survival is ≥ 12 weeks;\n7. The function of important organs is basically normal:\n\n   1. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   2. Renal function: serum creatinine≤2.0×ULN;\n   3. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤5.0×ULN;\n   4. Total bilirubin≤2.0×ULN (for Gilbert syndrome, total bilirubin≤3.0×ULN);\n   5. Blood oxygen saturation≥92% in non-oxygen state.\n8. No serious mental disorder;\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects of childbearing age agree to use reliable and effective contraceptive methods for contraception (excluding rhythm contraception) from signing the informed consent to receiving pCAR-19B cell infusion within 1 year.\n\nExclusion Criteria:\n\n1. Relapse of isolated extramedullary disease;\n2. Active central nervous system leukemia at screening, defined as Central Nervous System (CNS)-grade 2 and 3 according to National Comprehensive Cancer Network (NCCN) guidelines (note: those with central nervous system involvement but improved after treatment can be included);\n3. Those who have received CAR-T therapy or other gene-modified cell therapy before screening;\n4. Received anti-CD19 drug treatment before screening;\n5. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy and other drug treatments within 14 days or at least 5 half-lives (whichever is shorter); Received radiotherapy within 14 days;\n6. HBsAg or HBcAb positive and hepatitis B virus (HBV) DNA is greater than the normal range; hepatitis C virus (HCV) antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; Cytomegalovirus (CMV) DNA positive;\n7. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to enrollment (CABG);\n   3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (by vasovagal except those caused by menstruation or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n8. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;\n9. The presence of grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening;\n10. Cerebrovascular accident or epileptic seizure within 6 months before screening;\n11. Active autoimmune diseases；\n12. Patients with malignant tumors other than acute lymphoblastic leukemia within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and duct in situ after radical resection cancer;\n13. Received live attenuated vaccine within 4 weeks before screening;\n14. Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months from the time of cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from the time of cell reinfusion;\n15. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving pCAR-19B cell reinfusion;\n16. Other investigators deem it inappropriate to participate in the study.","3 Years",{"count":106,"type":19},100,[56],"This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed\u002Frefractory B-cell acute lymphoblastic leukemia.",[110,25,87],"Acute Lymphoblastic Leukemia",[112,113,114],"CAR-T","CD19","B-ALL","2024-07-30",{"date":117,"type":34},"2024-07-31",{"date":119,"type":34},"2022-01-26",{"date":121,"type":19},"2025-07-01",{"name":123,"class":124},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",10]