[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t---cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t---cell-lymphoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100583332","phase-1-nanobody-based-anti-cd5-car-t-for-relapsedrefractory-t-allnhl-100583332",false,"NCT06874946","Nanobody-Based Anti-CD5 CAR-T for Relapsed\u002FRefractory T-ALL\u002FNHL","A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL\u002FNHL): The CONQUER Trial","Phase I\u002FII","Inclusion Criteria:\n\n1. The subject or guardian understands and voluntarily signs the informed consent form (ICF).\n2. Male or female, aged 3-70 years at the time of signing the ICF (inclusive).\n3. Expected survival of at least 12 weeks.\n4. ECOG performance status of 0-2 at the time of ICF signing.\n5. Diagnosis of relapsed\u002Frefractory T-cell lymphoblastic leukemia\u002Flymphoma (R\u002FR T-ALL\u002FNHL) confirmed at screening and meeting at least one of the following criteria:\n\n   1. Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and\u002For\n   2. Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and\u002For\n   3. Extramedullary disease: Presence of measurable lesions (lymph node\u002Fmass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).\n   4. CD5 expression: Tumor cells in bone marrow, peripheral blood, or CSF are CD5-positive by flow cytometry, and\u002For lymph node\u002Fmass or extranodal lesions are CD5-positive by pathology.\n6. Adequate major organ function, defined as:\n\n   1. AST and ALT ≤5× upper limit of normal (ULN).\n   2. Total bilirubin ≤2× ULN.\n   3. Renal function: Serum creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula) or creatinine ≤1.5× ULN.\n7. Blood oxygen saturation \\>92%.\n8. Reproductive health requirements:\n\n   * Fertile men and women of childbearing potential must agree to use effective contraception from ICF signing until 2 years after study drug administration.\n   * Women of childbearing potential (pre-menopausal or within 2 years post-menopause) must have a negative blood pregnancy test at screening.\n\nExclusion Criteria:\n\n1. History of central nervous system (CNS) diseases, including but not limited to:\n\n   * Epilepsy\n   * Paralysis\n   * Aphasia\n   * Stroke\n   * Severe brain injury\n   * Dementia\n   * Parkinson's disease\n   * Neuropathy\n2. History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:\n\n   * Crohn's disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis\n   * Inflammatory bowel disease (IBD)\n   * Vasculitis\n   * Psoriasis\n3. Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.\n4. Positive virological or infectious disease markers, including:\n\n   * Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.\n   * Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.\n   * Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.\n   * Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.\n   * Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.\n   * Positive serological or non-specific antibodies for Treponema pallidum (syphilis).\n5. Clinically significant cardiovascular diseases, including any of the following:\n\n   1. QTc interval ≥480 ms (Fridericia correction formula)\n   2. New York Heart Association (NYHA) Class II or higher heart failure\n   3. Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%\n   5. Poorly controlled hypertension (as determined by the investigator)\n   6. Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:\n\n      * Persistent ventricular tachycardia\n      * Ventricular fibrillation\n      * Torsades de pointes\n      * Complete left bundle branch block\n6. History of severe hypersensitivity or allergy to any components of the study drug.\n7. Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).\n8. Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.\n9. Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0).\n10. Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg\u002Fday prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:\n\n    1. Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections)\n    2. Systemic corticosteroids ≤10 mg\u002Fday prednisone (or equivalent physiological dose)\n    3. Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT)\n    4. Steroids used for symptomatic treatment of transfusion-related reactions\n11. Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period.\n12. History of active tuberculosis infection within 1 year prior to signing the ICF, except for subjects with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of active tuberculosis.\n13. History of other primary malignancies within 5 years prior to signing the ICF, except for:\n\n    1. Adequately treated carcinoma in situ of the cervix\n    2. Localized basal cell carcinoma or squamous cell carcinoma of the skin\n14. Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period.\n15. Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation.\n16. Pregnancy or lactation.","ALL","3 Years","70 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL\u002FNHL",[29,30,31],"Precursor T-Cell Lymphoblastic Leukemia-Lymphoma","T - Cell Lymphoma","PTCL",[33,34,35],"CD5","R\u002FR T-ALL\u002FLBL","R\u002FR PTCL","RECRUITING","2026-05-01",{"date":39,"type":40},"2026-05-07","ACTUAL",{"date":42,"type":40},"2025-02-14",{"date":44,"type":22},"2027-12-31",{"name":46,"class":47},"Peking University People's Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100601148","phase-2-clinical-study-of-the-safety-and-efficacy-of-asct-combined-with-cd7-cart-in-the-treatment-of-cd7-tcl-100601148","NCT07106723","Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL","A Clinical Study of the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Combination With CD7-CART in the Treatment of CD7+ T-Cell Lymphoma","Inclusion Criteria:\n\n1. With the subject's consent and having signed the informed consent form, willing and capable of adhering to the planned visits, study treatment, laboratory tests and other trial procedures;\n2. Age 18 to 65 years old, both male and female;\n3. Confirmed as T-cell non-Hodgkin's lymphoma type (including T-lymphoblastic lymphoma\u002Fleukemia) according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022), and meeting one of the following three conditions: 1) Newly diagnosed with high-risk factors, such as Ann Arbor stage III\u002FIV, large mass, bone marrow invasion, central nervous system (CNS) invasion, ETP phenotype, RAS activating mutation, TP53 deletion\u002Fmutation, etc., as assessed by the investigator; 2) Not achieving PR or better response after induction and consolidation therapy; 3) Patients not considered for allogeneic hematopoietic stem cell transplantation;\n4. Confirmed as tumor cells expressing CD7 by histopathology and\u002For cytology at the time of screening;\n5. With appropriate organ function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), if the investigator determines that the abnormal ALT and AST are due to the disease (such as liver infiltration or bile duct obstruction), the indicators can be relaxed to ≤ 5 times ULN; 2) Total serum bilirubin ≤ 2 times ULN, except for patients with Gilbert's syndrome; patients with Gilbert's syndrome and total bilirubin ≤ 3 times ULN and direct bilirubin ≤ 1.5 times ULN can be included; 3) Serum creatinine clearance rate ≥ 30 mL\u002Fmin; 4) International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN; 5) Possessing the minimum level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and non-oxygen-dependent blood oxygen saturation ≥ 92%; 6) Left ventricular ejection fraction ≥ 50% by echocardiography; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion and pleural effusion.\n6. Women of childbearing age have a negative blood\u002Furine pregnancy test within 7 days before infusion. Any male and female patients with fertility must agree to use effective contraceptive methods throughout the study and for at least 2 years after the administration of study treatment.\n\n   \\-\n\nExclusion Criteria:\n\nSubjects with one or more of the following are not eligible for this study:\n\n1. History of allergy to any of the components in the cell product;\n2. Severe cardiac disease, including but not limited to: Myocardial infarction, cardiac angioplasty, or stenting within 6 months prior to signing the ICF; unstable angina; severe cardiac arrhythmias; History of severe non-ischemic cardiomyopathy; Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV), NYHA score listed in Appendix II\n3. Have a history of autologous\u002Fallogeneic hematopoietic stem cell transplantation;\n4. stroke or seizure within 6 months prior to signing the ICF;\n5. Have autoimmune diseases, immunodeficiencies or other diseases that require immunosuppressant treatment;\n6. Within 3 years prior to signing the ICF, have malignancies other than T-cell hematologic tumors, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, carcinoma in situ of the duct in situ after radical resection, carcinoma in situ of other sites one year after radical resection, and there has been no treatment during the screening period and there is no sign of recurrence;\n7. presence of uncontrolled active infection;\n8. Unstable systemic diseases judged by the investigator: including but not limited to severe hepatic, renal or metabolic diseases requiring drug treatment;\n9. Any of the following within 4 weeks prior to lymphocyte collection:\n\nThe DNA detection value of hepatitis B virus (HBV) in peripheral blood was higher than the lower limit of detection; Positive for hepatitis C virus (HCV) antibody and positive for peripheral HCV-RNA; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antigen or antibody; Positive for CMV-DNA (10) application of prednisone (or equivalent amounts of other corticosteroids) in excess of 5mg\u002Fday within 1 week prior to lymphocyte collection; (11) Have used any CAR-T cell products or other genetically modified T-cell therapies; (12) Received CD7-targeted therapy; (13) History of live vaccination within 4 weeks prior to signing the ICF; (14) Have a history of alcoholism, drug abuse, or mental illness; (15) Other situations that the investigator considers unsuitable to participate in this study.\n\n\\-","18 Years","65 Years",{"count":59,"type":22},50,[26],"To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL",[63,30],"CD7 Positive","2025-07-30",{"date":66,"type":40},"2025-08-06",{"date":68,"type":40},"2025-06-01",{"date":70,"type":22},"2030-01-07",{"name":72,"class":47},"Institute of Hematology & Blood Diseases Hospital, China"]