[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fl":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860",false,"NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[28,29,30,31,32,33],"DLBCL","CLL","FL","MCL","WM","MZL","RECRUITING","2026-05-10",{"date":37,"type":38},"2026-05-13","ACTUAL",{"date":40,"type":38},"2025-11-29",{"date":42,"type":21},"2029-11-28",{"name":44,"class":45},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100552545","phase-2-zanubrutinib-and-g-chop-in-untreated-intermediate-high-risk-follicular-lymphoma-100552545","NCT06474481","Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma","A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma","Inclusion criteria.\n\n1. Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a\n2. Have had no prior systemic treatment for lymphoma\n3. Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment\n4. 18-75 years old.\n5. ECOG Performance Status of 0-2 within 10 days prior to registration.\n6. Stage II, III, or IV by Ann Arbor staging system.\n7. defined as Intermediate-high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.\n8. Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n   * Hematological: WBC≥3.5×109\u002FL, Platelets ≥ 75×109\u002FL,Absolute Neutrophil Count (ANC) ≥ 1.0×109\u002FL，Hemoglobin (Hgb) ≥ 80 g\u002FL\n   * Renal:Calculated creatinine clearance ≥ 50 mL\u002Fmin\n   * Hepatic:Bilirubin ≤ 1.5 × upper limit of normal (ULN), AST\u002FALT ≤ 2.5×ULN\n9. Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). See the protocol.\n10. Life expectancy ≥6 months\n11. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study\n\nExclusion criteria:\n\n1. Known active central nervous system lymphoma or leptomeningeal disease\n2. Evidence of diffuse large B-cell transformation\n3. Grade 3b FL\n4. Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial\n5. Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus infection\n6. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification. Or left ventricular ejection fraction \\\u003C50%;\n7. Neuropathy ≥grade 2\n8. Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection\n9. Known pneumonia associated with idiopathic pulmonary fibrosis, machine (for example, occlusive bronchiolitis), history of drug induced pneumonia, or screening during the chest computed tomography (CT) showed active pneumonia\n10. Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania\n11. Patients who were deemed by the investigator to be ineligible for enrollment",{"count":55,"type":21},30,[25],":This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.",[30],[60,61,62],"Zanubrutinib","Intermediate-high risk Follicular Lymphoma","G-CHOP","NOT_YET_RECRUITING","2024-06-19",{"date":66,"type":38},"2024-06-25",{"date":68,"type":21},"2024-07",{"date":70,"type":21},"2029-12",{"name":72,"class":45},"Tianjin Medical University Cancer Institute and Hospital",""]