[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550340":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":74,"collaborators":78,"id":82,"slug":24,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":24,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":24,"enrollmentInfo":90,"targetDuration":24,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation","EXPERIMENTAL","CD19\u002FCD22-CAR-transduced T cells at escalating doses (0.5\\~5.0 ×10\\^6 cells\u002Fkg)",[13],"Biological: KQ-2002 CAR-T cells （CD19\u002FCD22 CAR T-Cells）",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose expansion","CD19\u002FCD22-CAR-transduced T cells at MTD or highest dose administered",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","KQ-2002 CAR-T cells （CD19\u002FCD22 CAR T-Cells）","CD19\u002FCD22 cells will be infused on Day1 after induction chemotherapy regimen.\n\nLymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide.\n\nFludarabine 30 mg\u002Fm2\u002Fday IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg\u002Fm2\u002Fday IV x 2 days (days -5 and-3)",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Rong Tao, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Weijing Zhang","CONTACT","021-64175590","88503","JJYIN555@163.com",[37,56],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Nanchang University;","RECRUITING","Nanchang","Jiangxi","360000","China",{"type":45,"coordinates":46},"Point",[47,48],115.85306,28.68396,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":24,"email":54},"Fei Li, MD","13970038386","lifeigcp@2022@163.com",{"name":52,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":57,"status":39,"city":58,"state":59,"zip":60,"country":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":45,"coordinates":62},[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67,70,73],{"name":27,"role":32,"phone":68,"phoneExt":24,"email":69},"8621-64175590","rtao@shca.org.cn",{"name":71,"role":32,"phone":68,"phoneExt":24,"email":72},"Wenhao Zhang, MD","zwhl98@foxmail.com",{"name":27,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Rong Tao","Chief physician",[79],{"name":80,"class":81},"Novatim Immune Therapeutics (Zhejiang) Co., Ltd.","INDUSTRY","100550340",false,"NCT06445803","CD19\u002FCD22 CAR-T Cells in Adults With R\u002FR ALL or NHL","A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19\u002FCD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Male or female,≥18 years old;\n* Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):\n\n(B-NHL)\n\n1. Second or greater relapse (CD20 regimens must be included) OR\n2. Refractory to first-line chemotherapy or relapse within 1 year OR\n3. Relapse within 1 year of auto-HSCT.\n4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)\n\na. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR\u002FCRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.\n\n* ECOG 0\\~2\n* Estimated survival time ≥ 12 weeks;\n* Main tissues and organs function well.\n\nExclusion Criteria:\n\n* Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg\u002Fd or equivalent) within 72 h\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；\n* active bleeding, or venous thromboembolic event\n* Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs\n* Central nervous system (CNS) disease or symptoms of CNS involvement\n* Pregnant or nursing (lactating) women\n* Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded\n* Any Iinappropriate conditions in the opinion of the PI .","ALL","18 Years",{"count":91,"type":92},48,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This study examines the safety, tolerability and preliminary efficacy of anti-CD19 \u002FCD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.",[98,99,100,101],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia With Failed Remission","B-cell Lymphoma Refractory","B-cell Lymphoma Recurrent",[103],"CAR-T therapy","2024-06-01",{"date":106,"type":107},"2024-06-06","ACTUAL",{"date":109,"type":107},"2024-05-31",{"date":111,"type":92},"2026-12",{"name":76,"class":6},2]