[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585984":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":27,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD5 CAR-NK cells","EXPERIMENTAL",null,[13],"Biological: Anti-CD5 CAR NK cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Anti-CD5 CAR NK cells","Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Jia Wei, MD","CONTACT","+86 13986102084","（0351）837 9851","jiawei@tjh.tjmu.edu.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":37,"coordinates":38},"Point",[39,40],114.26667,30.58333,{"lat":40,"lon":39},[43],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100585984","phase-1-clinical-trial-of-cd5-targeted-car-nk-therapy-for-relapserefractory-t-cell-hematologic-malignancies-100585984",false,"NCT06909474","Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse\u002FRefractory T-Cell Hematologic Malignancies","Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse\u002FRefractory T-Cell Hematologic Malignancies","Inclusion Criteria:\n\n\\-\n\n1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:\n\n1. T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts\u002Fimmature lymphocytes and\u002For flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:\n\n   1. Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).\n   2. Relapsed within 12 months after achieving CR with first-line induction therapy.\n   3. Failure to achieve CR or relapse after ≥2 lines of chemotherapy.\n   4. Relapse after hematopoietic stem cell transplantation (HSCT).\n2. T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK\u002FT-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia\u002Flymphoma (ATLL), mycosis fungoides\u002FSézary syndrome (MF\u002FSS) stage IIB or higher), and meets both:\n\n   1. At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions \\>1.5 cm in long axis; extranodal lesions \\>1.0 cm in long axis.\n   2. Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.\n\n      3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity \\[MFI\\] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (\\>30% tumor cells express CD5).\n\n      4.ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:\n\n   \u003C!-- -->\n\n   1. Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.\n   2. Renal: Serum creatinine ≤2.0×ULN.\n   3. Hepatic: ALT\u002FAST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.\n   4. Pulmonary: Oxygen saturation ≥92% (room air). 7.No Contraindications: To leukapheresis, venipuncture, or cell collection. 8.No Severe Psychiatric Disorders. 9.Contraception: Agreement to use effective contraception from informed consent until 1 year post-CAR-NK infusion (for patients of childbearing potential).\n\n      10.Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.\n\nExclusion Criteria:\n\n1. Prior CAR-NK therapy or genetically modified cell therapy.\n2. Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).\n3. Recent Anticancer Therapy:\n\n   1. Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.\n   2. Radiotherapy within 2 weeks prior to screening.\n4. Active\u002FUncontrolled Infection: Within 1 week prior to screening.\n5. Cerebrovascular Event or Seizure: Within 6 months prior to screening.\n6. Viral Infections:\n\n   1. HBV DNA \\> ULN (if HBsAg+ or HBcAb+).\n   2. HCV RNA \\> ULN (if HCV Ab+).\n   3. HIV+, syphilis+, or active tuberculosis.\n7. Cardiac Disease:\n\n   1. NYHA Class III\u002FIV congestive heart failure.\n   2. Myocardial infarction or CABG ≤6 months prior.\n   3. Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal\u002Fdehydration-related).\n   4. Severe cardiomyopathy.\n8. Active\u002FUncontrolled Autoimmune Disease.\n9. Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal\u002Fsquamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n10. Live Vaccination: Within 4 weeks prior to screening.\n11. Pregnancy\u002FLactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.\n12. Other: Investigator-determined ineligibility.","ALL","18 Years","75 Years",{"count":57,"type":58},15,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed\u002Frefractory T-Cell hematologic malignancies.",[64],"T-ALL\u002FLymphoma",[66,67,68,69,70,71,72,73,74],"T-ALL","T-LBL","PTCL-NOS","AITL","ALCL","ENKL","T-PLL","ATLL","MF\u002FSS","2025-03-27",{"date":77,"type":78},"2025-04-03","ACTUAL",{"date":75,"type":78},{"date":81,"type":58},"2028-03-31",{"name":5,"class":6},1]