[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488484":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":46,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":23,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":23,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":23,"overallStatus":84,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ThisCART19A cells infusion","EXPERIMENTAL","In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia.",[13,14,15,16],"Drug: ThisCART19A","Drug: Fludarabine Pill","Drug: Cyclophosphamide","Drug: VP-16 Protocol",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","ThisCART19A","ThisCART19A is a new type CAR-T therapy for patients with r\u002Fr B Cell Malignancy .",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Fludarabine Pill","Fludarabine is used for lymphodepletion.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Cyclophosphamide","Cyclophosphamide is used for lymphodepletion.",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"VP-16 Protocol","VP-16 is used for lymphodepletion.",[9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Keshu zhou, Dr.","CONTACT","+86-13674902391","drzhouks77@163.com",{"name":43,"role":39,"phone":44,"phoneExt":23,"email":45},"Jun Li, Ph.D","+86-18662604088","jli@ctigen.com",[47],{"facility":48,"status":23,"city":49,"state":50,"zip":23,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":23},"Henan cancer hospital","Zhengzhou","Henan","China","CN",{"type":54,"coordinates":55},"Point",[56,57],113.64861,34.75778,{"lat":57,"lon":56},{"type":60,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[62],{"name":63,"class":64},"Fundamenta Therapeutics, Ltd.","INDUSTRY","100488484","phase-1-assessment-of-safety-and-efficacy-of-thiscart19a-in-adult-patients-with-b-cell-malignancies-after-failure-of-autologous-chimeric-antigen-receptor-t--cellcar-t-therapy-100488484",false,"NCT05640713","Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy","A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy","Inclusion Criteria:\n\n1. Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；\n2. No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；\n3. Failing to autologous CAR-T therapy；\n4. Should be confirmed Cluster of differentiation(CD)19 positive；\n5. The expected survival time is ≥12 weeks;\n6. ECOG score 0-1;\n7. Measurable or detectble disease at time of enrollment.\n8. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；\n\nExclusion Criteria:\n\n1. Allergic to preconditioning measures；\n2. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical\u002Fbreast cancer can be recruited；\n3. Uncontrollable bacterial, fungal and viral infection during screening；\n4. Patients had pulmonary embolism (PE) and\u002For deep vein thrombosis (DVT) within 3 months prior to enrollment;\n5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；\n6. The presence of central nervous system involvement；\n7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \\\u003C 2000 IU\u002FmL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；\n8. Had big lesion(single lesion diameter ≥10 cm)；\n9. Receive allogeneic hematopoietic stem cell transplantation less than 100 days；\n10. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live\u002Fnon-live adjuvant vaccinations allowed to be included)；\n11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；\n12. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.","ALL","18 Years","75 Years",{"count":76,"type":77},12,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.",[83],"Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited","UNKNOWN","2022-11-28",{"date":87,"type":88},"2022-12-07","ACTUAL",{"date":90,"type":77},"2022-12-01",{"date":92,"type":77},"2025-08-01",{"name":5,"class":6},1]