[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wm":71},{"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":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100628282","phase-2-efficacy-and-safety-of-lisaftoclax-apg-2575-monotherapy-in-patients-with-indolent-lymphoma-100628282","NCT07459608","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Histologically confirmed diagnosis of an indolent lymphoma (CLL\u002FWM\u002FMZL), meeting one of the following conditions:\n\n   Cohort A: Previously untreated and ineligible for Bruton's Tyrosine Kinase inhibitor (BTKi) therapy due to severe comorbidities (e.g., uncontrolled hypertension, cardiac disease, or active infection, etc.).\n\n   Cohort B: Received only one prior line of BTKi as first-line treatment, did not achieve a partial response (PR), and discontinued BTKi due to intolerable treatment-related adverse events (e.g., atrial fibrillation, hemorrhage, infection, rash, etc.).\n3. Adequate bone marrow function, defined as:\n\n   1. Hemoglobin (Hb) ≥ 70 g\u002FL (without transfusion support within 7 days prior to the first dose of study drug).\n   2. Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL (independent of growth factor support within 7 days prior to the first dose of study drug).\n   3. Platelet count ≥ 50 × 10⁹\u002FL (without transfusion support within 7 days prior to the first dose of the study drug. If the patient has documented bone marrow involvement, a platelet count ≥ 30 × 10⁹\u002FL is acceptable, provided the investigator ensures adequate supportive care).\n4. Adequate hepatic and renal function, defined as:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).\n   2. Creatinine clearance (Ccr) ≥ 40 ml\u002Fmin (estimated by the Cockcroft-Gault formula).\n   3. Total bilirubin \\\u003C 1.5 × ULN.\n5. Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN, 50%).\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 3.\n7. Life expectancy ≥ 3 months.\n8. Men, women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant), and their partners must agree to use highly effective contraception methods (e.g., condoms, implants\u002Finjections\u002Foral contraceptives, intrauterine devices \\[IUD\\], abstinence, or a sterilized partner) during the treatment period and for 90 days after the last dose of the study drug. Postmenopausal women (at least 12 months of spontaneous amenorrhea) or surgically sterile women are not considered WOCBP.\n9. No other active malignant disease within the past 3 years, except for currently treated basal cell\n\nExclusion Criteria:\n\n1. Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.\n2. Patients with active infection (including active hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\] infection, or human immunodeficiency virus \\[HIV\\] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection\u002Fquantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection\u002Fquantification).\n3. Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.\n4. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.\n5. Administration of any live vaccine within 28 days prior to the first dose of the study drug.\n6. Women of childbearing potential (WOCBP) or men with partners of childbearing potential who are unwilling to use highly effective contraception; pregnant or breastfeeding women.\n7. Inability to swallow tablets, or presence of malabsorption syndrome, any disease significantly affecting gastrointestinal function, gastrectomy\u002Fsmall bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial\u002Fcomplete bowel obstruction.\n8. Known hypersensitivity to the active pharmaceutical ingredient, excipients of the study drug, or its analogs.\n9. Requirement for concomitant treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A.\n10. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's judgment, could compromise the patient's safety or pose an undue risk for study participation.",{"count":54,"type":21},75,[25],"This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment.\n\nEligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.",[58,32,33,59],"Indolent Lymphoma","CLL \u002F SLL","NOT_YET_RECRUITING","2026-03-11",{"date":63,"type":38},"2026-03-13",{"date":65,"type":21},"2026-03-10",{"date":67,"type":21},"2028-03-01",{"name":69,"class":70},"Henan Cancer Hospital","OTHER_GOV",""]