[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-b-cell-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-b-cell-malignancies":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,70,91,112,137,156,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100640247","phase-1-a-study-of-the-lvivo-tavec122-product-in-subjects-with-relapsedrefractory-b-cell-malignancies-100640247",false,"NCT07628582","A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed\u002FRefractory B-cell Malignancies","An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the LVIVO-TaVec122 Product in Subjects With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Subjects voluntary agreement to provide written informed consent.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one evaluable tumor lesion.\n5. Relapsed and\u002For refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and\u002For refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.\n6. Clinical laboratory values meet screening visit criteria.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy with insufficient washout period.\n2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Female subjects who were pregnant, breastfeeding.\n6. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed\u002FRefractory B-cell Malignancies.",[26],"Relapsed\u002FRefractory B-cell Malignancies",[28],"B-cell malignancies","NOT_YET_RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-05","ACTUAL",{"date":35,"type":20},"2026-09-15",{"date":37,"type":20},"2030-09-30",{"name":39,"class":40},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100616768","phase-1-iaso208-injection-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100616768","NCT07309900","IASO208 Injection in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Single-arm, Open-label Exploratory Clinical Study of IASO208 Injection in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled in this study:\n\n1. Aged ≥18 years and ≤75 years.\n2. Voluntary participation in this study and signing the informed consent form.\n3. Prior histopathological biopsy confirming a diagnosis of one of the following pathological types:\n\n   * Diffuse Large B-Cell Lymphoma (DLBCL), including High-Grade B-Cell Lymphoma (HGBL);\n   * Grade 3b Follicular Lymphoma (FL3b);\n   * DLBCL transformed from indolent lymphoma (FL or MZL);\n   * Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Mantle cell lymphoma.\n4. For B-cell lymphoma patients with relapsed\u002Frefractory diseases who have failed standard treatment assessed by investigator (including relapse, non-remission, and progression);\n\n   * Relapsed disease is defined as disease relapse or progression occurring ≥12 months after the end of prior therapy.\n   * Refractory disease is defined as disease progression during treatment, best response of stable disease (SD), relapse within 12 months after autologous hematopoietic stem cell transplantation, or disease progression occurring within 12 months after the end of prior therapy.\n5. CD20 positivity confirmed by detection on tumor biopsy specimens obtained after the last relapse or during the screening period.\n6. Presence of at least one measurable lesion according to the Lugano 2014 criteria (nodal lesion with Long Axis Diameter \\[LDi\\] \\>1.5 cm, extranodal lesion with LDi \\>1.0 cm).\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n8. Life expectancy ≥12 weeks.\n9. Adequate organ function, as demonstrated by the following laboratory results\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥1.0 × 10⁹\u002FL; Absolute Lymphocyte Count (ALC) ≥0.3 × 10⁹\u002FL; Platelet count (PLT) ≥50 × 10⁹\u002FL; Hemoglobin (Hb) ≥70 g\u002FL (must not have received any Granulocyte Colony-Stimulating Factor \\[G-CSF\\] or Granulocyte-Macrophage Colony-Stimulating Factor \\[GM-CSF\\] treatment, or transfusion of red blood cells or platelets within 7 days prior to the laboratory assessment).\n   2. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin ≤ 2 × ULN (for subjects with documented liver involvement by tumor: ALT\u002FAST ≤5 × ULN; Total Bilirubin ≤3 × ULN).\n   3. Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50%, as measured by echocardiography or Multigated Acquisition (MUGA) scan.\n   4. Oxygen saturation \\>92% (by pulse oximetry) at rest.\n   5. Renal function: Creatinine Clearance (CrCl) ≥40 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n   6. Coagulation profile: Fibrinogen ≥1.0 g\u002FL; Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN; Prothrombin Time (PT) ≤1.5 × ULN.\n10. Subjects of childbearing potential must agree to use highly effective contraceptive methods from the time of signing the informed consent form until at least 1 year after the last dose of IASO208 injection.\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria will be excluded from this study:\n\n1. Subjects with central nervous system involvement.\n2. Subjects who have had other malignancies within 5 years prior to screening, except for appropriately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.\n3. Subjects who meet any of the following conditions in infectious disease screening:\n\n   1. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA test (abnormal HBV DNA is defined as: quantitative detection higher than the lower limit of detection \\[LLD\\], above the normal range, or positive qualitative detection).\n   2. Subjects positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA.\n   3. Subjects positive for human immunodeficiency virus (HIV) antibody.\n   4. Subjects with syphilis.\n   5. Subjects with active cytomegalovirus (CMV) infection.\n4. Uncontrolled active bacterial, fungal, or viral infection prior to enrollment, as evidenced by:\n\n   1. Persistent infection-related symptoms\u002Fsigns requiring intravenous anti-infective therapy; or\n   2. No improvement in clinical symptoms or examinations after appropriate anti-infective therapy.\n5. Severe cardiac diseases, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] Class ≥ III), or severe arrhythmia.\n6. History of central nervous system diseases or disorders within 6 months prior to screening, such as epilepsy, paralysis, aphasia, cerebral infarction, cerebral hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome (e.g., cerebral aneurysm, epilepsy, stroke \\[except for lacunar infarction\\], dementia, psychosis), or subjects with impaired consciousness.\n7. Previous solid organ transplantation.\n8. Previous allogeneic hematopoietic stem cell transplantation (allo-HSCT), allogeneic CAR-T therapy, or other allogeneic donor adoptive cell therapies.\n9. Subjects who do not meet the required washout periods for the following prior therapies\u002Ftreatments before enrollment:\n\n   1. Cytotoxic chemotherapy, monoclonal antibodies, bispecific antibodies, or antibody-drug conjugates (ADCs) within 4 weeks prior to enrollment.\n   2. Ongoing requirement for systemic corticosteroids or other immunosuppressive therapy within 4 weeks prior to enrollment.\n   3. Radiotherapy or major surgery of Grade 4 severity within 4 weeks prior to enrollment; or planned general anesthesia surgery within 12 weeks after receiving the study treatment.\n   4. Vaccination or treatment with any investigational products within 4 weeks prior to enrollment.\n   5. Autologous hematopoietic stem cell transplantation or autologous CAR-T therapy within 12 weeks prior to enrollment.\n10. Presence of other unstable systemic diseases, as determined by the investigator, including but not limited to severe hepatic, renal, or metabolic diseases requiring treatment.\n11. Adverse events from previous anti-tumor therapies have not resolved to baseline or Grade ≤ 2 (excluding alopecia, fatigue, and peripheral neuropathy).\n12. Known history of hypersensitivity to any excipient component of the IASO208 injection.\n13. Pregnant or lactating women.\n14. Any other condition deemed by the investigator as inappropriate for participation in the study.","75 Years",{"count":51,"type":20},12,[23],"This is an investigator-initiated, single-arm, open-label clinical study. It employs a dose-escalation design to evaluate the safety, pharmacokinetics, and preliminary efficacy of IASO208 injection in relapsed\u002Frefractory B-cell malignancies.",[26],[56,57,58,59],"in vivo CAR-T","CD20","IASO208","Relapsed\u002F Refractory B-cell malignancies","RECRUITING","2026-05-27",{"date":63,"type":33},"2026-06-01",{"date":65,"type":33},"2025-11-21",{"date":67,"type":20},"2029-06-15",{"name":69,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100593105","phase-1-the-cd19cd20-dual-target-in-vivo-car-t-lentiviral-product-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100593105","NCT07002112","The CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.\n2. Age greater than or equal to 18.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one evaluable tumor lesion.\n5. Relapsed and\u002For refractory NHL , and relapsed and\u002For refractory CLL with treatment indications\n6. Life expectancy≥ 3 months\n7. Clinical laboratory values meet screening visit criteria\n8. Adequate organ function;\n\nExclusion Criteria:\n\nSubject eligible for this study must not meet any of the following criteria:\n\n1. Prior antitumor therapy with insufficient washout period ;\n2. Prior treatment with lentiviral vector-based gene therapies;\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Lactating women;",{"count":78,"type":20},30,[23],"A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies.",[26],"2026-05-11",{"date":84,"type":33},"2026-05-14",{"date":86,"type":33},"2025-05-23",{"date":88,"type":20},"2029-06-30",{"name":39,"class":40},6,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100630861","phase-1-phase-i-clinical-study-to-evaluate-sys6055-injection-in-participants-with-relapsedrefractory-b-cell-malignancies-100630861","NCT07493174","Phase I Clinical Study to Evaluate SYS6055 Injection in Participants With Relapsed\u002FRefractory B-Cell Malignancies","Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6055 Injection in Participants With Relapsed\u002FRefractory B-Cell Malignancies","Inclusion Criteria:\n\n* Age≥18 year, and voluntarily signed the Informed Consent Form (ICF);\n* Histologically confirmed B-cell malignancy with CD19 antigen-positive tumor cells;\n* Patients with relapsed\u002Frefractory B-cell malignancies who have failed standard therapy, including B-cell leukemia and B-cell lymphoma;\n* At least one measurable lesion according to the 2014 Lugano Response Criteria for Lymphoma;\n* ECOG performance status score of 0-1;\n* Expected survival of at least 3 months;\n* Adequate organ and bone marrow function;\n* Eligible participants (males and females) of reproductive potential must agree to use a reliable method of contraception (hormonal contraception, barrier method, or abstinence) with their partner during the trial and for at least 1 year after dosing. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. In addition, female participants must agree not to donate oocytes (eggs, ova) for assisted reproductive technology for 1 year after dosing, and male participants must agree not to donate sperm for assisted reproductive technology for 1 year after dosing;\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* History of other malignancy within 3 years or concurrent other active malignancy (participants with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., may be enrolled);\n* Participants with bleeding diathesis, active bleeding, hemoptysis, or history of major bleeding within the previous 6 months; tumor invasion of major blood vessels shown by imaging (CT or MRI), or tumor judged by the investigator as highly likely to invade major blood vessels and cause fatal massive bleeding during the subsequent study period;\n* Participants with B-cell malignancies involving the central nervous system;\n* Received autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;\n* Previous allogeneic bone marrow transplantation, gene therapy, or adoptive cell therapy (including CAR-T therapy);\n* Received anti-PD-1, anti-PD-L1, or T-cell engager therapy within 3 months prior to the first dose; received fludarabine or bendamustine within 6 months prior to the first dose;\n* Adverse events from prior antineoplastic therapy have not recovered to CTCAE Version 6.0 grade ≤1 (except for alopecia or other toxicities without safety risk as judged by the investigator);\n* Received major surgery, chemotherapy, radical radiotherapy, antibody-based targeted therapy, imunotherapy, or other antineoplastic therapy within 28 days prior to dosing; or received palliative radiotherapy, chemotherapy, or small-molecule targeted therapy within 14 days prior to dosing; or received antineoplastic herbal preparations or traditional Chinese patent medicines within 14 days prior to dosing;\n* Simultaneously participating in another clinical trial, unless it is an observational (non-interventional) clinical trial or in the follow-up phase of an interventional trial (without impact on the follow-up data of this study);\n* Received live vaccine within 4 weeks prior to dosing;\n* Active bacterial, fungal, or viral infection prior to dosing. Individuals receiving prophylactic antimicrobial therapy without clinical manifestations of active infection prior to dosing may be considered for enrollment;\n* Autoimmune disease requiring systemic therapy;\n* History of central nervous system disease or current persistent central nervous system disease that may interfere with neurological assessments;\n* History of immunodeficiency or positive HIV antibody test during screening;\n* History of tuberculosis treatment within 2 years prior to dosing; history of active syphilis;\n* Active hepatitis B or hepatitis C during screening. Active hepatitis B is defined as HBsAg-positive and HBV DNA above the upper limit of normal (ULN). Active hepatitis C is defined as HCV antibody-positive and HCV RNA \\> ULN;\n* History of severe cardiovascular disease;\n* Hypersensitivity or intolerance to the excipients of SYS6055 (mainly human albumin);\n* Any other conditions in participants that may interfere with compliance with study procedures, are not in the best interest of participants, or may affect study results: e.g., history of psychiatric disorders, drug addiction or substance abuse, any other clinically significant diseases or conditions, etc.;\n* Pregnant or lactating female;\n* Any other reason judged by the investigator that the participant is not suitable for participation in this clinical trial.",{"count":99,"type":20},86,[23],"(Limit: 5000 characters) The purpose of this phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6055 Injection in participants with relapsed\u002Frefractory B-cell malignancies, and to provide evidence for recommending a dosage regimen for subsequent studies.",[103],"Relapsed\u002FRefractory B-Cell Malignancies","2026-04-13",{"date":106,"type":33},"2026-04-15",{"date":106,"type":20},{"date":109,"type":20},"2030-04-15",{"name":111,"class":40},"Institute of Hematology & Blood Diseases Hospital, China",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":41},"100619523","clinical-study-evaluating-the-safety-and-efficacy-of-baffr-car-t-therapy-for-relapsedrefractory-b-cell-malignancies-100619523","NCT07345728","Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed\u002FRefractory B-cell Malignancies","A Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\nPatients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatment procedures of the study; Age 18-85 years (inclusive), gender not restricted; Patients with relapsed\u002Frefractory B-cell lymphoma who have received prior treatment including anti-CD20 targeted agents (unless documented CD20 negative) and anthracycline-containing regimens; Pathological immunohistochemistry of tumor confirms positive BAFFR target expression at screening; Patients have recovered from the toxicities of previous treatments, i.e., CTCAE toxicity grade \\\u003C 2 (unless abnormalities are tumor-related or judged by the investigator to be stable and not significantly affecting safety or efficacy); ECOG performance status 0-2 and life expectancy \\> 3 months;\n\nAdequate organ function:\n\n1. Alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN);\n2. Aspartate transaminase (AST) ≤ 3 × ULN;\n3. Total bilirubin ≤ 1.5 × ULN;\n4. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n5. Hemoglobin ≥ 60 g\u002FL or maintained at this level after transfusion;\n6. Room air oxygen saturation ≥ 92%;\n7. Left ventricular ejection fraction (LVEF) ≥ 45%; Accessible venous access for apheresis and no contraindications to leukapheresis.\n\nExclusion Criteria:History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid cancer, basal or squamous cell skin cancer, localized prostate cancer after radical therapy, and ductal carcinoma in situ after radical therapy; Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV-RNA; positive for human immunodeficiency virus (HIV) antibody; History of severe allergies \\[severe allergy is defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest\\] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimen); History of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after \\> 1 month of treatment with reasonable, tolerable, and adequate doses of ≥ 3 antihypertensive drugs (including diuretics), or requires ≥ 4 antihypertensive drugs to achieve effective blood pressure control); Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment; Previous organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation); Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); Presence of tumor emergencies (e.g., spinal cord compression, bowel obstruction, leukostasis, tumor lysis syndrome, etc.) requiring urgent treatment at screening or before infusion; Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment; Use of short-acting hematopoietic growth factors affecting blood counts within 1 week, or long-acting hematopoietic growth factors within 2 weeks prior to planned CAR-T manufacturing apheresis, and judged by the investigator to affect cell manufacturing;\n\nReceiving corticosteroids or immunosuppressive drugs within 2 weeks prior to planned CAR-T manufacturing apheresis, and judged by the investigator to affect cell manufacturing:\n\n1. Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned CAR-T manufacturing apheresis and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use);\n2. Immunosuppressants: Subjects receiving immunosuppressive agents within 2 weeks prior to planned CAR-T manufacturing apheresis; Major surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds before enrollment; Vaccination with (live-attenuated) viral vaccines within 4 weeks prior to screening; History of severe mental illness; History of alcoholism or substance abuse; Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion; Subjects with contraindications to any study procedures or other medical conditions that may pose unacceptable risks according to the investigator's judgment and\u002For clinical standards.","78 Years",{"count":121,"type":20},28,[123],"NA","This is a prospective, single-arm, multi-center, randomized controlled clinical study designed to evaluate the safety and efficacy of BAFFR CAR-T therapy for relapsed\u002Frefractory B-cell malignancies. A total of 30 subjects are planned to be enrolled.",[26],[127],"relapsed\u002Frefractory B-cell malignancies","2026-01-07",{"date":130,"type":33},"2026-01-16",{"date":132,"type":20},"2026-01-01",{"date":134,"type":20},"2029-06-01",{"name":136,"class":40},"Donghua Zhang",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":41},"100611468","early-phase-1-safety-and-efficacy-of-zzsw-01-in-relapsedrefractory-b-cell-malignancies-100611468","NCT07240974","Safety and Efficacy of ZZSW-01 in Relapsed\u002FRefractory B-cell Malignancies","A Clinical Study to Evaluate the Safety and Efficacy of ZZSW-01 in the Treatment of Patients With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria:\n\n1. Age ≥18 years, no restriction on sex.\n2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2.\n3. Expected survival ≥3 months.\n4. Histologically or cytologically confirmed CD19-positive relapsed or refractory B-cell malignancies according to the WHO classification of lymphoid neoplasms, including:\n\n   Relapsed\u002Frefractory B-NHL: patients who have failed at least two prior lines of therapy, are intolerant to the toxicity of second-line regimens, or are not eligible for autologous stem cell transplantation, including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL\u002Fhigh-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, and transformed large B-cell lymphoma from indolent B-NHL.\n\n   Relapsed\u002Frefractory precursor B-ALL: patients who relapse after achieving CR following second-line therapy, or who fail to achieve CR\u002FCRi after completion of second-line therapy.\n5. For relapsed\u002Frefractory B-NHL: at least one measurable lesion as assessed by the investigator (e.g., lymph node with long axis \\>15 mm, or extranodal lesion with long axis \\>10 mm).\n\n   For relapsed\u002Frefractory precursor B-ALL: baseline bone marrow blasts ≥5%.\n6. Adequate organ function as defined below (no administration of blood components or hematopoietic growth factors within 14 days prior to first dosing):\n\n   Hematology:\n\n   Relapsed\u002Frefractory B-NHL: ANC ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥70 g\u002FL, absolute CD8+ T-cell count ≥0.3×10\\^9\u002FL; if bone marrow involvement is present: ANC ≥1.0×10\\^9\u002FL, platelets ≥50×10\\^9\u002FL, hemoglobin ≥70 g\u002FL.\n\n   Relapsed\u002Frefractory precursor B-ALL: ANC ≥1.0×10\\^9\u002FL (G-CSF support permitted), platelets ≥50×10\\^9\u002FL (no platelet transfusion within 7 days), hemoglobin ≥80 g\u002FL (no RBC transfusion within 7 days); if bone marrow involvement or not in remission: ANC ≥0.5×10\\^9\u002FL (G-CSF support permitted), platelets ≥30×10\\^9\u002FL (no platelet transfusion within 7 days), hemoglobin ≥70 g\u002FL (no RBC transfusion within 7 days). Additionally, absolute CD8+ T-cell count ≥0.2×10\\^9\u002FL and CD19+ B-cell percentage ≤5%.\n\n   Liver function: TBIL ≤1.5×ULN; ALT and AST ≤2.5×ULN (≤5×ULN if liver metastases are present).\n\n   Renal function: Serum creatinine ≤1.5×ULN (if \\>1.5×ULN, creatinine clearance must be ≥50 mL\u002Fmin).\n\n   Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN; patients on anticoagulation may be included if INR ≤2.5×ULN.\n\n   Oxygenation: Oxygen saturation \\>92% on room air.\n7. Non-hematologic toxicities from prior therapies (except disease-related) have resolved to ≤grade 1 before enrollment (excluding alopecia and ≤grade 2 neurotoxicity from chemotherapy).\n8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to ZZSW-01 infusion. All fertile male and female participants must agree to use effective contraception during the study and for at least 6 months after the last dose. (Definition of women of childbearing potential and contraceptive methods are detailed in Appendix 1.)\n9. Ability and willingness to provide written informed consent and to comply with study procedures, follow-up assessments, and treatment.\n\nExclusion Criteria\n\nParticipants meeting any of the following conditions will be excluded from this study:\n\n1. Patients with CNS involvement of B-cell malignancies confirmed by lumbar puncture and\u002For MRI with CNS-related symptoms.\n2. Patients with isolated extramedullary relapse of B-ALL.\n3. Patients with severe hereditary diseases or congenital hematopoietic dysfunction.\n4. Patients with Burkitt's lymphoma\u002Fleukemia or blast phase chronic myeloid leukemia (p210 BCR-ABL+).\n5. Current or past history of central nervous system disorders, including: seizures, ischemic\u002Fhemorrhagic cerebrovascular disease, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric illness, or any autoimmune disease involving the CNS.\n6. Receipt of chemotherapy within 2 weeks prior to ZZSW-01 infusion (except intrathecal chemotherapy for prevention of CNS leukemia, which must be stopped ≥1 week prior to infusion).\n7. Prior systemic immune checkpoint inhibitor therapy (e.g., anti-PD-1\u002FPD-L1 mAbs) within fewer than 3 half-lives before ZZSW-01 infusion; or other systemic antitumor therapy within fewer than 2 weeks or 5 half-lives (whichever is shorter) before infusion.\n8. Use of systemic therapeutic corticosteroids within 72 hours prior to ZZSW-01 infusion (physiologic replacement doses are allowed, e.g., prednisone \\\u003C10 mg\u002Fday or equivalent).\n9. Receipt of targeted therapies or antibody drugs (including BiTEs, antibody-drug conjugates) within 2 weeks, or cytotoxic therapy within 1 week prior to ZZSW-01 infusion.\n10. Autologous stem cell transplantation (ASCT) within 6 weeks prior to ZZSW-01 infusion.\n11. Any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n12. Known history of the following diseases:\n\n    1. . Systemic vasculitis (e.g., Wegener's granulomatosis, polyarteritis nodosa)\n    2. Systemic lupus erythematosus (SLE)\n    3. . Active or uncontrolled autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, autoimmune hemolytic anemia)\n    4. . Primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases)\n13. Evidence of any of the following infections:\n\n    1. . Chronic or active hepatitis B (HBV) infection (except HBcAb-positive with HBV DNA \\\u003C500 IU\u002FmL)\n    2. . Hepatitis C virus (HCV) infection\n    3. . Human immunodeficiency virus (HIV) infection\n    4. . Syphilis infection\n14. Major surgery within 4 weeks prior to screening, if deemed unsuitable for enrollment by the investigator.\n15. Concurrent active malignancy. (Patients with prior malignancies cured ≥2 years may be eligible).\n16. Any of the following cardiac conditions:\n\n    1. . Left ventricular ejection fraction (LVEF) ≤45% (by echocardiography)\n    2. . NYHA class III or IV congestive heart failure\n    3. . Severe arrhythmia requiring treatment, including QTc ≥450 ms in males or ≥470 ms in females (QTcB=QT\u002FRR1\u002F2)\n    4. . Uncontrolled hypertension (systolic ≥140 mmHg and\u002For diastolic ≥90 mmHg), pulmonary hypertension, or unstable angina\n    5. . Myocardial infarction, bypass surgery, or stent placement within 12 months prior to dosing\n    6. . Clinically significant valvular heart disease\n    7. . Any other cardiac disease deemed unsuitable by the investigator\n17. Lymphoma involving the atrium or ventricle.\n18. Clinical emergencies caused by obstruction or compression from lymphoma masses at screening (e.g., bowel obstruction, vascular compression).\n19. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening.\n20. Hypersensitivity (allergy to ≥2 drugs or foods), or known hypersensitivity to components of the investigational product (compound electrolyte injection, 5% human serum albumin).\n21. Receipt of live vaccines within 6 weeks prior to screening.\n22. Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).\n23. Participation in another interventional clinical trial with investigational drugs within 3 months prior to ZZSW-01 infusion, or intent to participate in another clinical trial or receive non-protocol antitumor therapy during the study.\n24. Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation.",{"count":90,"type":20},[146],"EARLY_PHASE1","This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed\u002Frefractory B-cell malignancies.",[26],"2025-11-16",{"date":65,"type":33},{"date":152,"type":33},"2025-10-28",{"date":154,"type":20},"2028-09-15",{"name":69,"class":40},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100561499","phase-1-ubx-303061-in-subjects-with-relapsedrefractory-b-cell-malignancies-100561499","NCT06590961","UBX-303061 in Subjects With Relapsed\u002FRefractory B-Cell Malignancies","A Phase Ia\u002FIb, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed\u002FRefractory B-Cell Malignancies","Key Inclusion Criteria\n\n* Capable of giving signed informed consent\n* Age ≥18 years\n* ECOG performance status ≤2.\n* Phase Ia (dose-escalation part only): Subjects with relapsed and\u002For refractory B-cell malignancies (CLL\u002FSLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.\n* Phase Ib (dose-expansion only): Subjects with relapsed and\u002For refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL\u002FSLL or DLBCL or MCL or FL, WM, MZL\n* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria\n\n* For subjects with lymphoma:\n\n  * Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.\n  * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.\n  * Unconjugated monoclonal antibody therapies \\\u003C6 weeks before the first dose of study treatment.\n  * Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.\n  * Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.\n  * Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.\n  * History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.\n  * Any immunotherapy within 4 weeks of first dose of study drug.\n  * The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \\\u003C5 times the t1\u002F2 of the previously administered agent(s).\n* Previously exposed to BTK degradation therapy\n* Malignant disease, other than that being treated in this study.\n* Radiotherapy within 2 weeks of the first dose of study treatment\n* Known hypersensitivity to BTK degraders or any of the ingredients.\n* Impaired cardiac function or clinically significant cardiac disease\n* Subjects with history of severe bleeding disorders and known\u002Fsuspected other autoimmune disease\n* Major surgery within 4 weeks of the first dose of study treatment",{"count":164,"type":20},94,[23],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed\u002Frefractory B-cell malignancies.",[26],{"date":169,"type":33},"2025-11-19",{"date":171,"type":33},"2025-02-20",{"date":173,"type":20},"2027-08",{"name":175,"class":176},"Ubix Therapeutics, Inc.","INDUSTRY",11,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100499190","phase-1-a-study-of-ac676-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100499190","NCT05780034","A Study of AC676 for the Treatment of Relapsed\u002FRefractory B-Cell Malignancies","A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).\n2. Patients with histologically confirmed relapsed\u002Frefractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).\n3. Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n1. Treatment with any of the following:\n\n   * Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).\n   * Systemic chemotherapy within 14 days.\n   * Radiation therapy within 14 days\n   * Biologics (Antibodies) treatment within 28 days,\n   * Radioimmunoconjugates or toxin conjugates within 12 weeks.\n   * Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. For patients with DLBCL, no prior CAR- T therapy is allowed.\n   * Autologous or allogenic stem cell transplant within 100 days and must not have ongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.\n2. History of central nervous system lymphoma\u002Fleukemia in remission for less than 2 years.\n3. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.",{"count":186,"type":20},60,[23],"This clinical trial is evaluating a drug called AC676 in participants with Relapsed\u002FRefractory B-cell Malignancies. The main goals of the study are to:\n\n* Identify the recommended dose of AC676 that can be given safely to participants\n* Evaluate the safety profile of AC676\n* Evaluate the pharmacokinetics of AC676\n* Evaluate the effectiveness of AC676",[26],[191,192,193,194,195,196,197,198,199,200,201,202],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)","Mantle Cell Lymphoma (MCL)","Follicular Lymphoma (FL)","Non-Germinal Center B-cell (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)","Marginal Zone Lymphoma (MZL","Waldenström Macroglobulinemia (WM)","Non-Hodgkin Lymphoma (NHL)","Bruton's tyrosine kinase-BTK","BTK Degrader","AC676","AC0676","2025-09-29",{"date":205,"type":33},"2025-10-02",{"date":207,"type":33},"2023-06-20",{"date":209,"type":20},"2026-05-31",{"name":211,"class":176},"Accutar Biotechnology Inc",9]