[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,69,86,103,130,149,179,214,237,265,286,308,330,349,388,414,436,455,476],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100515708","phase-1-4scar19u-t-cells-targeting-b-cell-malignancies-100515708",false,"NCT05995015","4SCAR19U T Cells Targeting B Cell Malignancies","Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Primary B cell surface expression of CD19.\n3. The KPS score over 80 points, and survival time is more than 1 month.\n4. Greater than Hgb 80 g\u002FL.\n5. No contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. Accompanied with other active diseases, and difficult to assess response after treatment.\n2. Bacterial, fungal, or viral infection, unable to control.\n3. Living with HIV.\n4. Active HBV or HCV infection.\n5. Pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. Prior failed CAR-T treatment.","ALL","6 Months","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.",[27],"B Cell Malignancies",[29,30,31,32,33],"Universal CAR-T","CD19 B-ALL","PMBCL","CNS-BCL","BCL","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":38},"2026-06-01",{"date":42,"type":21},"2030-12-31",{"name":44,"class":45},"Shenzhen Geno-Immune Medical Institute","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":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":46},"100472793","phase-1-cd1979b-bi-specific-car-t-cell-therapy-100472793","NCT05436509","CD19\u002F79b Bi-specific CAR-T Cell Therapy","CD19\u002F79b Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD79b molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CD19 and CD79b CAR-T treatment.",{"count":55,"type":21},60,[24,57],"PHASE2","The purpose of this study is to assess the feasibility, safety and efficacy of CD19\u002F79b bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F79b bi-specific CAR-T cells and their persistency in patients.",[27],[61,62,63,64],"CAR-T","B cell Malignancies","CD19","CD79b",{"date":37,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":85,"locationsCount":46},"100472515","phase-1-cd1922-bi-specific-car-t-cell-therapy-100472515","NCT05432882","CD19\u002F22 Bi-specific CAR-T Cell Therapy","CD19\u002F22 Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD22 molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.4. active HBV or HCV infection.\n\n5\\. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.",{"count":55,"type":21},[24,57],"The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19\u002F22 bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F22 bi-specific CAR-T cells and their persistency in patients.",[27],[61,62,63,81],"CD22",{"date":37,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":102,"locationsCount":46},"100472792","phase-1-cd1970-bi-specific-car-t-cell-therapy-100472792","NCT05436496","CD19\u002F70 Bi-specific CAR-T Cell Therapy","CD19\u002F70 Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD70 molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CD19 and CD70 CAR-T treatment.",{"count":20,"type":21},[24,57],"The purpose of this study is to assess the feasibility, safety and efficacy of CD19\u002F70 bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F70 bi-specific CAR-T cells and their persistency in patients.",[27],[61,62,63,98],"CD70",{"date":37,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":46},"100295411","phase-1-combination-car-t-cell-therapy-targeting-hematological-malignancies-100295411","NCT03125577","Combination CAR-T Cell Therapy Targeting Hematological Malignancies","Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19\u002FCD20\u002FCD22\u002FCD30\u002FCD38\u002FCD70\u002FCD123 molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases, the treatment is difficult to assess patient response.\n2. bacteria, fungus, or virus infection, unable to control.\n3. living with HIV.\n4. active HBV and HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CAR-T treatment.",{"count":111,"type":21},100,[24,57],"The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[115],"B-cell Malignancies",[117,63,118,81,119,120,121,122,98,123],"4S CAR-T","CD20","CD38","CD123","B cell leukemia","B-ALL","CD30",{"date":37,"type":38},{"date":126,"type":38},"2025-08-01",{"date":128,"type":21},"2029-12-31",{"name":44,"class":45},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":148,"locationsCount":46},"100289625","phase-1-a-phase-iii-multiple-center-trial-of-4scar19-cells-in-the-treatment-of-relapsed-and-refractory-b-cell-malignancies-100289625","NCT03050190","A Phase I\u002FII Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies","Inclusion Criteria:\n\n1. aged more than 6 months.\n2. malignant B cell surface expression CD19 molecules.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater Hgb 80 g\u002FL.\n5. no contraindications to solid and cell separation\n\nExclusion Criteria:\n\n1. accompanied with other active diseases, the treatment is difficult to correct.\n2. bacteria, fungus, or virus infection, unable to control.\n3. people living with HIV.\n4. active HBV and HCV infection.\n5. of pregnancy and nursing mothers.\n6. before entering the test of the use of glucocorticoid systemic treatment within a week.\n7. confirmed before used CAR - but invalid",{"count":137,"type":21},200,[24,57],"The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[115],[142,143,63,121,122],"CART therapy","4SCAR19",{"date":37,"type":38},{"date":146,"type":38},"2025-05-01",{"date":128,"type":21},{"name":44,"class":45},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":178},"100613828","phase-2-a-study-of-emavusertib--an-approved-bruton-tyrosine-kinase-inhibitor-btki-in-participants-with-chronic-lymphocytic-leukemia-cll-and-other-b-cell-malignancies-100613828","NCT07271667","A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies","A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies","Inclusion Criteria (All Parts):\n\n1. Males and females ≥ 18 years of age.\n2. Life expectancy of ≥ 3 months.\n3. Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2.\n4. Histopathologically confirmed diagnosis of CLL (medical record is acceptable), as per the World Health Organization 2016 classification.\n5. At least 1 criterion for measurable disease per International Workshop on Chronic Lymphocytic Leukemia (iwCLL).\n6. For Cohort 1 only:\n\n   1. Participant must be in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+) per Hallek et al, (2018) criteria.\n   2. Participant must have detectable measurable residual disease (MRD) as determined by the ClonoSEQ assay\n   3. Must be actively taking zanubrutinib for at least 12 months.\n   4. Acceptable organ function at Screening within 28 days prior to Cycle 1 Day 1 (C1D1)\n7. For Cohort 2 only:\n\n   1. Relapsed disease for which participants are ineligible for or have exhausted standard therapeutic options that would be considered standard of care\n   2. Must be actively taking zanubrutinib.\n   3. Participants must have had direct progression on zanubrutinib (within 3 months prior to study entry; administered as monotherapy or in combination) and no other anticancer therapy administered since.\n   4. Acceptable organ function at Screening within 28 days prior to C1D1.\n8. Creatine phosphokinase (CPK) \\\u003C 2.5 × ULN.\n9. Ability to tolerate a contrast-enhanced computed tomography (CT) scan.\n10. Ability to swallow and retain oral medications.\n11. Negative serum pregnancy test in women of childbearing potential (WOCP).\n12. WOCP and men who partner with WOCP must agree to use highly effective contraceptive methods for the duration of the study and for 180 days after the last dose of study treatment.\n13. Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria (All Parts):\n\n1. Active second malignancy unless in remission with a life expectancy of \\> 2 years and with documented Sponsor approval.\n2. Active malignancy other than CLL requiring systemic therapy (exceptions may be granted following a discussion with the Sponsor Medical Monitor).\n3. Have high-risk CLL TP53 mutations and 17P deletion.\n4. History of Grade ≥ 3 rhabdomyolysis without complete recovery.\n5. Received prior chimeric antigen receptor-T cell therapy.\n6. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to C1D1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to C1D1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing uptitration of immunosuppressive medications prior to Screening.\n7. Any prior systemic anticancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 (with the exception of zanubrutinib, which may be continued until the day before C1D1).\n8. Receiving the following medications within 7 days or 5 half-lives, whichever is shorter, prior to C1D1:\n\n   1. Medications that, in the opinion of the Investigator, have a high risk of causing prolonged QT interval, corrected (QTc) and\u002For Torsades de Pointes.\n   2. Peg-filgrastim or equivalent.\n   3. St John's Wort.\n9. History of or ongoing drug-induced pneumonitis.\n10. History of stroke or intracranial hemorrhage within 6 months prior to C1D1. Participants with post-biopsy hemorrhagic sequela defined as a small hyperdense lesion \\\u003C 3 millimeters (mm) on T2 sequence will not be excluded.\n11. Requirement for anticoagulation with warfarin or equivalent vitamin K antagonists, including dual antiplatelet agents, within 5 half-lives of the anticoagulant or 7 days, whichever is longer, prior to C1D1. Low molecular weight heparin is allowed. Participants who require the use of antiplatelet agents should be discussed with the Sponsor Medical Monitor (e.g., use of factor Xa inhibitors).\n12. Vaccinated with a live-attenuated vaccine within 4 weeks prior to C1D1.\n13. Prior history of hypersensitivity or anaphylaxis to emavusertib, zanubrutinib, or any of their excipients.\n14. Prior history of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Intolerance to contrast-enhanced CT scan due to allergic reactions to contrast agents.\n16. Major surgery \\\u003C 28 days prior to C1D1; minor surgery \\\u003C 7 days prior to C1D1.\n17. Viral infections:\n\n    1. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome (AIDS)-related illness. If HIV is undetectable or maintained on treatment, enrollment may be allowed after discussion with the Sponsor Medical Monitor.\n    2. Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive or hepatitis C virus (HCV) infection \\\u003C 6 months prior to C1D1, unless viral load is undetectable, or HCV with cirrhosis.\n    3. Active systemic infection, including HIV, cytomegalovirus infection, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or has had, within 28 days prior to C1D1, an infection (other than nail trichophytosis) that requires hospitalization or an intravenous antibiotic.\n18. Concomitant illness that would preclude safe participation in the study.\n19. Pregnant or lactating female.","18 Years",{"count":158,"type":21},108,[57],"The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.",[162,115],"Chronic Lymphocytic Leukemia",[164,165,115,162,166,167],"Emavusertib","BTKi","CLL","Zanubrutinib","2026-06-11",{"date":170,"type":38},"2026-06-12",{"date":172,"type":38},"2026-04-23",{"date":174,"type":21},"2027-11",{"name":176,"class":177},"Curis, Inc.","INDUSTRY",11,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":20},"100557756","phase-1-a-study-to-evaluate-safety-pk-pd-and-efficacy-of-azd5492-a-t-cell-engaging-antibody-targeting-cd20-in-subjects-with-rr-b-cell-malignancies-100557756","NCT06542250","A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R\u002FR B-Cell Malignancies.","A Modular Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)","TITANium","Inclusion Criteria:\n\n* ≥18 years of age;\n* Histologically documented CD20+ mature B-cell neoplasm\n\n  * Large B-cell lymphoma\n  * Follicular lymphoma\n  * Mantle cell lymphoma\n  * Chronic lymphocytic leukemia\n  * Small lymphocytic lymphoma\n* Relapsed, progressive and\u002For refractory disease following at least 2 prior lines of therapy;\n* ECOG performance status of ≤ 2 (\\\u003C 2 in EU countries).\n\nThe above is a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Any neoplasm histology not specified in the IC section;\n* Active CNS involvement in lymphoma;\n* CNS pathology including but not limited to any history of seizure disorder\u002Fepilepsy;\n* Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;\n* History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;\n* Active and uncontrolled infections;\n* Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":188,"type":21},174,[24,57],"This is a Phase I\u002FII study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.",[115],[118,193,194,195,196,197,198,199,200,201,202,203,185,204],"CD8","T cell engager","TCR","AZD5492","Relapsed, Refractory","B-cell malignancies","CLL, Chronic lymphocytic leukemia","SLL, Small lymphocytic lymphoma","MCL, Mantle cell lymphoma","LBCL, Large B-cell lymphoma","FL, Follicular lymphoma","TCE","2026-04-30",{"date":207,"type":38},"2026-05-01",{"date":209,"type":38},"2024-09-18",{"date":211,"type":21},"2028-02-14",{"name":213,"class":177},"AstraZeneca",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":221,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":224,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100632563","expression-of-cd274-pd-l1-and-cd276-in-b-cell-malignancies-a-study-by-flowcytometry-100632563","NCT07515313","Expression of CD274 (PD-L1) and CD276 in B-cell Malignancies: A Study by Flowcytometry","Expression of CD274 (PD-L1) and CD276 in B-cell Malignancies: A Study by Flowcyometry","Inclusion Criteria:\n\nNewly diagnosed patients of both gender at any age with\n\n* Acute B- lymphoblastic leukemia. or\n* B- lymphoproliferative disorders (whether chronic lymphocytic leukemia or any other disorder)\n\nExclusion Criteria:\n\n* Patients with any other type of malignancies.\n* Patients that receiving chemotherapy.\n* Patients with any autoimmune diseases",true,{"count":223,"type":21},159,"OBSERVATIONAL","B-cell malignancies include a spectrum of cancers originating from abnormal B lymphocytes at different developmental stages (1) that affect the peripheral blood (PB), bone marrow (BM), and lymphatic system. They can be categorized into leukemias and lymphomas. Each has unique characteristics, depending on the type of cells affected, and different behaviors, ranging from chronic conditions with slow progression to aggressive forms that require immediate treatment (2).\n\nAcute lymphoblastic leukemia (ALL) is the most common hematologic malignancy in childhood and the predominant form of precursor B-cell leukemia globally, accounting for 85% of ALL cases. According to recent global burden estimates, ALL incidence increased to over 100 000 cases worldwide by 2021, corresponding to an age-standardized incidence rate of \\~1.4 per 100 000 persons per year (3). Its quick course and possibility of systemic involvement make early and prompt diagnosis and efficient treatment essential for enhancing long-term survival, especially in young patients.(4).\n\nB-Chronic lymphoproliferative disorders (B-CLPDs) are a diverse collection of illnesses that are defined by the uncontrolled and clonal expansion of mature B cells. Although they can range from indolent to aggressive, they usually impact elderly persons and have a slow-growing, indolent clinical history. These conditions account for more than 90% of all chronic lymphoid cancers (5).\n\nB-cell malignancies arise from disruption of immune system regulation through alterations in crucial signaling pathways, such as the B-cell receptor (BCR) signalling defect, imbalance between stimulatory signals (that drive proliferation and differentiation) and inhibitory signals (that enforce tolerance and prevent overstimulation) leading to anti-tumor immunity with development and metastasis of cancer cells (6).\n\nAn essential part of the immune regulatory system for malignancies, the B7-H family which is an important immune checkpoint provides new opportunities for modifying the tumor microenvironment (TME). This family is well-known for its several functions in controlling both innate and adaptive immunity. It is also involved in the recruitment and polarization of diverse immune cells and can have co-stimulatory or co-inhibitory effects on T cells, affecting processes like T cell activation, differentiation, and effector functions. Two important members in this family are: B7-H1 (PD-L1) also known CD274 and B7-H3 (CD276) (7).\n\nFirstly, PD-L1 (CD274) which bind to PD-1 . This interaction primarily result in suppresses effector T cell activity while promoting the activity of immunosuppressive regulatory T cells (Tregs), hence negatively regulating the adaptive immune response. However, in malignancy, cancer cells promote the PD-1\u002FPD-L1 axis to cause immune escape in cancer development and progression (8). It was reported that PD-L1 is widely expressed in solid tumors like melanoma and non-small cell lung cancer (9).\n\nSecondly, CD276, also called B7-H3, is abundantly expressed in cancer cells and activated tumor-infiltrating immune cells aiding in the evasion of cytotoxic T-cell and natural killer cell surveillance (10). According to new research, B7-H3 contributes to tumor growth, metastasis, and resistance to treatment, all of which have a negative impact on patient outcomes (11).\n\nTill now, the co-expression and functional relationship of CD274 and CD276 in B-cell malignancies remain poorly recognized. Understanding whether malignant B cells utilize multiple immune checkpoint pathways simultaneously may explain resistance to immunotherapy and identify novel prognostic and therapeutic targets.",[115],"NOT_YET_RECRUITING","2026-03-31",{"date":230,"type":38},"2026-04-07",{"date":232,"type":21},"2026-07-01",{"date":234,"type":21},"2030-12-01",{"name":236,"class":45},"Assiut University",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":46},"100631643","phase-1-a-phase-12-study-of-t-cell-expressing-a-novel-cd19-chimeric-antigen-receptor-shb-02-cd19-in-patients-with-cd19-expressing-b-cell-malignancies-100631643","NCT07503353","A Phase 1\u002F2 Study of T-cell Expressing a Novel CD19 Chimeric-Antigen Receptor (SHB-02-CD19) in Patients With CD19-expressing B-cell Malignancies","Inclusion Criteria:\n\n* Patient must have a CD19-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy and not eligible for current commercial CD19 CAR T cells per Israeli MOH health basket:\n\n  1. Relapse following standard relapse protocol (2nd relapse)\n  2. Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.\n  3. Patients who have histologically confirmed large B-cell lymphoma, according to the World Health Organization 2016 classification criteria, that are refractory to first-line treatment or that have relapsed from complete remission no more than 12 months after the completion of first-line chemo-immunotherapy including an anti-CD20 monoclonal antibody and anthracycline-containing regimen.\n  4. Very high risk 1st relapse of ALL, defined as (a) relapse within 18 months of initial diagnosis; (b) relapse with the following cytogenetic abnormalities: KMT2a-R, TCF3::HLF, TCF3::PBX1, TP53-alterations.\n* Age 1-80 years\n* For ALL, CD19 expression shown by flow cytometry or immunohistochemistry on at least 70% of leukemic blasts.\n* Adequate CD3 count (above 120 CD3+ cells per microliter blood)\n* Clinical performance status: Patients \\> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.\n* Females of child-bearing potential must have a negative pregnancy test\n* Cardiac function: LV ejection fraction \\>45% or shortening fraction \\>28%\n* At least 60 days after autologous or allogeneic BMT\n* No prior CD19 CAR T cell administered\n* Prior therapy:\n\n  1. Patients should be off steroids for at least 2 weeks prior to apheresis\n  2. Patients should be off systemic anti-neoplastic treatment for 2 weeks prior to apheresis, with the exception of intrathecal chemotherapy. Patients who received prior clofarabine and fludarabine should have a wash out period of 3 months prior to apheresis.\n  3. Patients should have recovered from all toxicities attributed to prior therapy. Cytopenias that are considered disease related rather than therapy related are exempt from this exclusion.\n  4. Radiation therapy should be completed at least 3 weeks prior to apheresis.\n\nExclusion Criteria:\n\n* Hyperleukocytosis (WBC\\>50,000) or rapidly progressive disease that in the judgment of the PI can compromise the ability of the patient to complete the study\n* Pregnant or breast-feeding females\n* Hepatic dysfunction, defined as bilirubin \\> x2 upper normal limit (except when explained by hemolysis or Gilbert) or SGOT \\> x2.5 upper normal limit.\n* Active HIV infection, HBV or HCV infection which is identified by positive PCR of viral sequences. Patients who are positive for HCV Abs, HBsAg and\u002For positive to HBcAbs total, will be evaluated by PCR of viral sequences. If PCR is positive, the patient will be excluded.","1 Year","80 Years",{"count":246,"type":21},50,[24,57],"This is a phase I\u002FII trial of SHB-02-CD19, T-cell expressing an anti-CD19 Chimeric-Antigen-Receptor (CAR) in patients with CD19 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed\u002Frefractory B-cell malignancies.",[27,250,251],"Acute Lymphobkastic Leukemia","Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell)",[16,253,254,61,255],"DLBCL","NHL","CD-19","2026-03-25",{"date":228,"type":38},{"date":259,"type":21},"2026-06",{"date":261,"type":21},"2030-01",{"name":263,"class":264},"Sheba Medical Center","OTHER_GOV",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":221,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":224,"phases":4,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":4},"100631358","immunophenotypic-evaluation-of-cd305-and-cd85d-in-b-cell-lymphoid-neoplasms-100631358","NCT07499635","Immunophenotypic Evaluation of CD305 and CD85d in B-Cell Lymphoid Neoplasms","Immunophenotypic Evaluation of Inhibitory Immune Receptors CD305 and CD85d in B-Cell Lymphoid Neoplasms","Inclusion Criteria:\n\n* \\- Newly diagnosed cases of B-cell acute lymphoblastic leukemia\u002Flymphoma or B CLPDs according to the WHO classification and established by morphology, immunophenotyping, and, if available, cytogenetic\u002Fmolecular findings.\n\nExclusion Criteria:\n\n* Patients diagnosed with hematologic malignancies other than B-cell acute lymphoblastic leukemia\u002Flymphoma or B CLPDs.\n* Patients who have received prior therapy, including chemotherapy or immunomodulatory treatment.\n* Patients refused to sign informed consent.",{"count":273,"type":21},180,"Inhibitory immune receptors, including CD85d and CD305 (LAIR-1), act as immune checkpoint-like molecules. They contain immunoreceptor tyrosine-based inhibitory motifs (ITIMs) that recruit SH2-domain phosphatases (e.g., SHP-1), which suppress cellular activation (7,8).\n\nCD85d is predominantly expressed in myeloid cells, including monocytes, macrophages, dendritic cells, and granulocytes. It is also differentially expressed on NK, T, B cells, and neutrophils. It is expressed at high levels in tumor cells, facilitating immune escape by promoting immune suppression, allowing for tumor evasion (9).\n\nCD85d is widely expressed across AML, so it is a top candidate, due to its traditional association with myeloid phenotypes and limited expression in normal haematopoiesis (10). It was reported to be expressed in B cells of CLL patients in contrast to normal B cells. Its expression in CLL patients denotes a distinctive feature, which may be acquired during malignant transformation (8). Therefore, CD85d may have significant prognostic, mechanistic, and therapeutic roles in hematologic malignancies (11).\n\nAs a novel biomarker in solid malignant tumors to predict the prognosis of patients, upregulation of CD85d in tumors is associated with worse tumor phenotypes. Targeting CD85d may be an effective tool for targeted cancer therapy (12).\n\nConcerning CD305, it has been reported in about 60% of CLL patients and may be used as an effective prognostic marker to predict TTFT in CLL patients (13).\n\nDespite their potential clinical significance, the expression patterns of CD85d and CD305 across B-cell lymphoid neoplasms subtypes remain incompletely identified. Illustrating their role may help to determine TTFT, prognosis, therapeutic targeting, and refinement of B-cell neoplasms classification in line with WHO-HAEM5 standards.",[27],[277],"CD85d, CD305, B-Cell Lymphoid Neoplasms","2026-03-24",{"date":280,"type":38},"2026-03-30",{"date":282,"type":21},"2026-09-06",{"date":284,"type":21},"2029-03",{"name":236,"class":45},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":46},"100619840","early-phase-1-exploratory-study-on-mrna-therapeutic-drug-targeting-cd19-for-the-treatment-of-hematologic-malignancies-100619840","NCT07349849","Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies","Inclusion Criteria:\n\n* 1\\. Age range of 18-70 years old, gender not limited;\n* 2\\. Expected survival time exceeds 12 weeks;\n* 3\\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines\n* 4\\. There are assessable lesions (applicable only to lymphoma patients);\n* 5\\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1;\n* May involve other inclusion criteria\n\nExclusion Criteria:\n\n* 1\\. Accompanied by other uncontrolled malignant tumors;\n* 2\\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;\n* 3\\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;\n* 4\\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;\n* 5\\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.\n\nMay involve other exclusion criteria","70 Years",{"count":294,"type":21},47,[296],"EARLY_PHASE1","Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed\u002Frefractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.\n\nThe advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.\n\nThe core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.",[115],"2026-01-15",{"date":301,"type":38},"2026-01-20",{"date":303,"type":21},"2025-12-20",{"date":305,"type":21},"2028-12-31",{"name":307,"class":45},"Xinqiao Hospital of Chongqing",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":244,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":46},"100603357","phase-1-a-phase-12-study-of-t-cell-expressing-an-anti-cd22-chimeric-antigen-receptor-shb-04-cd22-in-patients-with-cd22-expressing-b-cell-malignancies-100603357","NCT07135466","A Phase 1\u002F2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies","Inclusion Criteria:\n\n* Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease):\n* Relapse following standard relapse protocol (2nd relapse), including CD19 CART.\n* Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.\n* Age 1-80 years\n* CD22 expression shown by flow cytometry on at least 70% of leukemic blasts \u002F lymphoma cells\n* Adequate CD3 count (above 120 CD3+ cells per microliter blood)\n* Clinical performance status: Patients \\> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.\n* Females of child-bearing potential must have a negative pregnancy test\n* Cardiac function: LV ejection fraction \\>45% or shortening fraction \\>28%\n* At least 60 days after autologous or allogeneic BMT\n* At least 30 days after prior CAR therapy in absence of response",{"count":246,"type":21},[24,57],"This is a phase I\u002FII trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed\u002Frefractory B-cell malignancies.",[27],[16,254,253,61,81,319,320,321],"Chimeric Antigen Receptor","Leukemia","Lymphoma","2026-01-14",{"date":324,"type":38},"2026-01-16",{"date":326,"type":21},"2026-02-01",{"date":328,"type":21},"2028-01-01",{"name":263,"class":264},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":292,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":4},"100618518","early-phase-1-exploratory-study-on-the-treatment-of-relapsed-and-refractory-b-cell-malignant-tumors-with-wgb-0301-injection-100618518","NCT07332663","Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection","Inclusion Criteria:\n\n* 1\\. Age range of 18-70 years old, gender not limited;\n* 2\\. Expected survival time exceeds 12 weeks;\n* 3\\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines and meeting the corresponding frontline treatment line requirements;\n* 4\\. There are assessable lesions (applicable only to lymphoma patients);\n* 5\\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;\n* 6\\. The main organ functions well and the relevant examination indicators meet the corresponding requirements;\n* 7\\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;\n* 8\\. Those who can understand this experiment and have signed the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Accompanied by other uncontrolled malignant tumors;\n* 2\\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;\n* 3\\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;\n* 4\\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;\n* 5\\. Participants with atrial or ventricular involvement;\n* 6\\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;\n* 7\\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;\n* 8\\. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial\u002Fvenous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;\n* 9\\. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;\n* 10\\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;\n* 11\\. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections);\n* 12\\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.",{"count":337,"type":21},9,[296],"Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed\u002Frefractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.\n\nThe advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. The core of LNP mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.\n\nThe experimental drug WGb-0301 injection is a CD19 based messenger RNA (mRNA) therapeutic mRNA drug, formed by loading mRNA onto lipid nanoparticles (LNP). WGb-0301 injection has demonstrated efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell malignancies, bringing better clinical benefits to more patients with B-cell malignancies.",[27],"2025-12-31",{"date":343,"type":38},"2026-01-12",{"date":345,"type":21},"2026-01-01",{"date":305,"type":21},{"name":348,"class":45},"Sichuan University",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":366,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":46},"100605748","phase-1-bispecific-car-t-cells-for-b-cell-malignancies-basecar-01-trial-100605748","NCT07166549","Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)","A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies","BaseCAR-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:\n\n  * Acute B-lymphoblastic leukaemia\n  * Burkitt lymphoma\n  * Primary CNS lymphoma\n  * DLBCL or high-grade lymphoma of any subtype\n  * Primary mediastinal B cell lymphoma (including grey zone lymphoma)\n  * Mantle Cell lymphoma\n  * Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)\u002F small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma\u002Fleukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma\n* CD19 and\u002For CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)\n* ECOG clinical performance status ≤2\n* Able to provide written informed consent.\n* Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:\n\n  * Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed)\n  * Adequate renal function: creatinine clearance ≥30 mL\u002Fmin\u002F1.73 m2\n  * Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \\> 91% with room air.\n  * Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia\n  * Adequate bone marrow reserve (Hemoglobin ≥80 g\u002FL (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\\^9\u002FL (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\\^9\u002FL (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\\^9\u002FL)\n* Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n* Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs\n* Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.\n* Uncontrolled coronary artery disease or uncontrolled arrhythmias\n* Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.\n* Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).\n* Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer).\n* Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.\n* Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide\n* Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG.\n* Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n* Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.\n* Investigational treatments within other trials ≤ 4 weeks before enrollment.\n* Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.",{"count":358,"type":21},12,[24],"This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma\u002Fleukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.",[27,362,363,364,365],"B-cell Leukemia","B Cell Lymphoma","Bispecific Chimeric Antigen Receptor (CAR) T Cells","Relapsed or Refractory (r\u002Fr) B-cell Malignancies",[367,368,369,370,371,372,373,374,375,376,377,378,379],"Bispecific anti-CD19, anti-CD20 CAR T cell therapy","lymphapheresis","lymphodepleting (non- myeloablative) chemotherapy","Immune effector cell-associated neurotoxicity syndrome (ICANS)","Cytokine release syndrome (CRS)","Immune effector cell-associated haematotoxicity (ICAHT)","European Group for Blood and Marrow Transplantation (EBMT)","18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)","positron emission computed tomography (PET CT)","acute lymphocytic leukemia (ALL)","immunoglobulin heavy chain (IGH)","non-Hodgkin's lymphoma (NHL)","Eastern Cooperative Oncology Group (ECOG)","2025-12-17",{"date":382,"type":38},"2025-12-24",{"date":259,"type":21},{"date":385,"type":21},"2028-11",{"name":387,"class":45},"University Hospital, Basel, Switzerland",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":395,"maxAge":18,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":46},"100597960","jy231jy231-injection-for-the-treatment-of-rr-b-cell-malignancies-100597960","NCT07065279","JY231(JY231) Injection for the Treatment of R\u002FR B-cell Malignancies","JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);\n2. Histologically confirmed as B-cell Malignancies ;\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin # 34 μ Mol\u002FL; Creatinine clearance rate\\>30 mL\u002Fmin; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109\u002FL, blood platelet(PLT)\\>30 × 109\u002FL, Hb\\>80 g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. Individuals with fertility must agree to the use of efficient contraceptive methods;\n9. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants.","2 Years",{"count":397,"type":21},36,[399],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.",[115],[403,61,404],"B cell tumor","in vivo","2025-07-03",{"date":407,"type":38},"2025-07-15",{"date":409,"type":21},"2025-07",{"date":411,"type":21},"2027-12",{"name":413,"class":45},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":46},"100589766","phase-1-evaluation-of-sys6005-in-patients-with-advanced-malignant-tumor-100589766","NCT06958679","Evaluation of SYS6005 in Patients With Advanced Malignant Tumor","A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Anti-tumor Activity of SYS6005 in Patients With Advanced Malignant Tumor","Inclusion Criteria:\n\n1. Participants who are voluntarily enrolled in this study and sign the informed consent form (ICF);\n2. Age ≥ 18 years old, male or female;\n3. Patients with advanced malignant tumors confirmed by cytology or histology, who have failed standard therapy or are intolerant to standard therapy and require systemic treatment： Solid tumor: Pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy. Preferred tumor types include breast, lung, gynecologic, prostate, skin, adrenal, testicular, colon, bladder, pancreatic, gastric, kidney, cholangiocarcinoma, and esophageal cancers.\n\n   B-cell malignancies: Pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 WHO classification, with disease progression on or after at least 2 lines of prior systemic therapy. Preferred tumor types include cHL, DLBCL, MCL, FL, MZL, RTL, CLL\u002FSLL;\n4. Patients with at least one evaluable lesion as defined per RECIST v1.1 for solid tumor or 2014 Lugano Classification Criteria for lymphoma, respectively;\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2;\n6. Expected survival ≥ 3 months;\n7. Participants must have adequate organ function and have not received transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medical supportive treatments within 14 days prior to examination\n8. For participants enrolled in the dose-expansion phase, tumor tissue must be confirmed as ROR1-positive by the central laboratory during screening in order to be eligible for enrollment.\n9. Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the ICF until at least 6 months after the last dose of the investigational product; female participants of childbearing potential must have a negative pregnancy test result within 7 days prior to the first administration of the investigational product;\n10. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Participants who have participated in other studies involving ROR1-targeted therapies prior to enrollment in this study, or have previously received ADC treatments containing MMAE payloads;\n2. Participants with known central nervous system (CNS) lymphoma or CNS metastases from solid tumors that are symptomatic, untreated, or require treatment. Except for participants with metastases to CNS that have been completely resected and\u002For have stabilized or improved after radiotherapy, provided that imaging examinations prior to screening show stable disease for at least 4 weeks, and there is no evidence of brain oedema and no requirement for corticosteroids or anticonvulsant drugs;\n3. Participants deemed suitable for CAR-T therapy or hematopoietic stem cell transplant (HSCT) by the investigator. Participants who have received an allogeneic haematopoietic stem cell transplant within 6 months prior to the first administration of the investigational product, have received an autologous haematopoietic stem cell transplant within 100 days prior to the first administration of the investigational product, or have received CAR-T cell therapy within 3 months prior to the first administration of the investigational product. Participants with active graft versus host disease;\n4. Participants have a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast or cancers that have been treated with no expectation of recurrence\n5. Participants have a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy For solid tumor: \\> 10 mg daily prednisone equivalents within 14 days prior to the administration of the first dose of SYS6005; For lymphoma: \\> 20 mg daily prednisone equivalents within 28 days prior to the administration of the first dose of SYS6005; The use of short-course systemic corticosteroids (≤ 7 days) is permitted, with a wash-out period of 1 week prior to the administration of the first dose of SYS6005\n6. Participants with peripheral oedema, pericardial effusion, pleural effusion, or ascites that require medical intervention or limit daily life activities;\n7. Participants with records of cerebrovascular events, angina unstable, myocardial infarction, or a history of NYHA Class III-IV cardiac symptoms within 6 months before the first administration of the investigational product, or a QTcF \\> 450 ms recorded in three repeated ECG examinations during screening;\n8. Participants with any active infection requiring systemic treatment within 2 weeks prior to the first dose of investigational product;\n9. Participants who have used strong inhibitors or inducers of CYP3A4 within 7 days prior to the first dose of the investigational product, or are expected to require the use of strong inhibitors or inducers of CYP3A4 during the study treatment;\n10. Participants with the severity of any toxicities from prior treatments or surgery (excluding ≤ Grade 2 alopecia, endocrine disorders manageable with hormone replacement therapy, or other toxicities that the investigator considers do not pose a safety risk to the patient) has not returned to baseline or ≤ Grade 1 per NCI-CTCAE Version 5.0;\n11. Participants with ≥ grade 2 peripheral neuropathy at baseline;\n12. Participants who have received major surgery, radical radiotherapy, antibody-based targeted therapy, or immunotherapy within 28 days prior to the first administration of the investigational product, or who have received palliative radiation, chemotherapy, or small molecule targeted therapy within 14 days prior to the study treatment. Participants who have used anti-tumor Chinese herbal preparations or Chinese patent medicines within 14 days prior to the first administration of the investigational product;\n13. Participants with history of immunodeficiency or positive human immunodeficiency virus (HIV) antibody test during screening;\n14. Participants with active hepatitis B or hepatitis C, where active hepatitis B is defined as HBsAg positive and HBV DNA \\> 2000 IU\u002Fml; active hepatitis C is defined as HCV antibody positive and HCV RNA \\> ULN;\n15. Participants who have received a live vaccine within 28 days prior to the first dose of investigational product;\n16. Participants with history of hypersensitivity or atopic reactions to excipients of the investigational product or any monoclonal antibodies;\n17. Women who are pregnant or breastfeeding;\n18. Other situations that may interfere with the participant's participation in the study program or are not in the participant's best interest or affect the study results include: history of mental illness, addiction or drug abuse, any other clinically significant illness or condition, etc.",{"count":422,"type":21},132,[24],"This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)\u002Frecommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.",[115,426],"Solid Tumors","2025-05-12",{"date":429,"type":38},"2025-05-14",{"date":431,"type":38},"2025-04-03",{"date":433,"type":21},"2028-06-30",{"name":435,"class":177},"CSPC Megalith Biopharmaceutical Co.,Ltd.",{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":292,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":4},"100555996","early-phase-1-an-exploratory-clinical-study-evaluating-the-safety-and-efficacy-of-intravenous-anti-cd20cd30-car-t-cell-infusion-in-relapsedrefractory-lymphoma-patients-100555996","NCT06519344","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20\u002FCD30-CAR-T Cell Infusion in Relapsed\u002FRefractory Lymphoma Patients.","Inclusion Criteria:\n\n(1) Voluntary participation in the clinical study; complete understanding by self or legally authorized guardian, informed of the study, and signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.\n\n(2) Age between 18 and 70 years.\n\n(3) Patients refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and unsuitable for other treatment options such as second hematopoietic stem cell transplantation. Refractory\u002Frelapsed lymphoma is defined as:\n\n1. No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):\n\n   \\- Progression of Disease (PD) assessment after first-line treatment\n   * Best response of Stable Disease (SD) after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD maintenance duration not exceeding 6 months after the last dose.\n2. No response to second-line or subsequent therapies:\n\n   * PD as best response to the most recent treatment regimen\n   * Best response of SD after at least 2 cycles of last-line treatment, with SD maintenance duration not exceeding 6 months after the last dose.\n3. Refractory post autologous stem cell transplantation (ASCT):\n\n   * Disease progression or relapse ≤12 months after ASCT (relapsing subjects must have biopsy-proven relapse)\n   * If salvage therapy is performed post-ASCT, subjects must have had no response or relapse after the last-line treatment.\n   * Relapsed or refractory disease after two or more lines of systemic therapy.\n\n     (4) Lymphoma patients with target antigens meeting the following criteria:\n   * CD20\u002FCD30 double-positive lymphomas\n   * Relapse after anti-CD19-CAR-T cell therapy, and CD20-positive lymphomas\n   * Never received anti-CD19-CAR-T cell therapy, CD20-positive lymphomas\n   * CD30-positive Hodgkin lymphoma.\n\n     (5) Included lymphoma subtypes:\n   * DLBCL-NOS (Diffuse Large B-Cell Lymphoma, not otherwise specified)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into DLBCL, refractory disease\n   * Mantle cell lymphoma\n   * High-grade B-cell lymphoma\n   * Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)\n   * Hodgkin lymphoma (HL).\n\n     (6) ECOG performance status ≤2.\n\n     (7) Expected survival of at least 12 weeks.\n\n     (8) Adequate venous access (for single collection), and no other contraindications for blood cell separation.\n\n     (9) Laboratory requirements at screening, with no hematologic evaluation within 7 days of receiving growth factors (long-acting granulocyte colony-stimulating factor (G-CSF\u002FPEG-CSF) requires a 2-week interval):\n   * Absolute neutrophil count ≥1.0×10\\^9\u002FL;\n   * Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 7 days);\n   * Platelets ≥50×10\\^9\u002FL (CLL indication unrestricted);\n   * Serum total bilirubin ≤1.5× upper limit of normal (ULN); or ≤3× ULN if liver tissue invasion by tumor;\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5× ULN, AST\u002FALT ≤5× ULN if liver tissue invasion by tumor;\n   * Creatinine \\\u003C1.5× ULN and estimated glomerular filtration rate ≥60 mL\u002Fminute.\n\n     (10) Left ventricular ejection fraction ≥45%, echocardiogram (ECHO) showing no clinically significant pericardial effusion (excluding minimal or physiological effusions), and no clinically significant findings on electrocardiogram.\n\n     (11) Baseline oxygen saturation \\>92% without supplemental oxygen.\n\n     (12) Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential).\n\nExclusion Criteria:\n\nHere is the translation of the exclusion criteria for participants in a clinical study:\n\n1. Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless CNS involvement has been effectively treated (i.e., participant is asymptomatic) and there has been a local treatment interval of \\>4 weeks prior to enrollment.\n2. Active central nervous system diseases such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.\n3. History of or concurrent malignancies other than CD19+ malignancies.\n4. Clinically significant cardiac disease, or arrhythmias not controlled by medication.\n5. Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous antibiotics; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed.\n6. Hepatitis B (positive hepatitis B surface antigen and hepatitis B DNA \\>1000 copies\u002FmL) and hepatitis C (positive hepatitis C antibody).\n7. Presence of any indwelling catheters or drainage tubes (e.g., percutaneous nephrostomy tube, Foley catheter, bile drainage tube, pleural\u002Fperitoneal\u002Fpericardial catheter); specialized central venous access devices like Port-A-Cath® or Hickman® catheters are allowed.\n8. Use of the following medications prior to:\n\n1\\) Ibrutinib within 1 day before apheresis. 2) Idelalisib (oral PI3Kδ inhibitor) within 2 days before apheresis. 3) Short-acting targeted therapy (such as tyrosine kinase inhibitors) within 72 hours before apheresis.\n\n4\\) Venetoclax (BCL-2 inhibitor) within 4 days before apheresis. 5) Long-acting growth factors (such as pegfilgrastim) within 14 days before apheresis, or short-acting growth factors or mobilizing agents (such as granulocyte colony-stimulating factor (G-CSF)\u002Ffilgrastim) within 5 days before apheresis.\n\n6\\) Pharmacologic doses of corticosteroid therapy (\\>5 mg\u002Fday prednisone or equivalent) and other immunosuppressive drugs within 7 days before enrollment.\n\n7\\) Radiotherapy within 14 days before enrollment. 8) Systemic cytotoxic drugs within 14 days before enrollment, including daily or weekly low-dose maintenance chemotherapy (e.g., cyclophosphamide, fludarabine, bendamustine, chlorambucil, methotrexate, vinblastine).\n\nIf bridging therapy is administered post-apheresis, there must be at least a 7-day interval between bridging therapy and CAR-T cell infusion.\n\n9\\) Anti-PD1 or anti-PDL1 therapy within 4 weeks before enrollment. 10) Vaccination within 4 weeks before enrollment. 11) Donor lymphocyte infusion (DLI) within 4 weeks before enrollment. 12) Immunostimulatory or immunosuppressive therapy within 3 months before enrollment (such as interferon-α, interferon-β, IL-2, lenalidomide, efalizumab, alemtuzumab, cyclosporine, or methotrexate).\n\n(9) Active graft-versus-host disease (GVHD) using the CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.\n\n(10) History in the past 2 years of autoimmune diseases causing end-organ damage or requiring systemic immunosuppressive\u002Fdisease-modifying agents, such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus.\n\n(11) History in the past 12 months of myocardial infarction, cardiac vascular procedures or stent implantation, unstable angina, or other clinically significant cardiac diseases.\n\n(12) History of genetic syndromes with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome.\n\n(13) Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation therapy within 6 months before enrollment. Subjects requiring prophylactic anticoagulation are allowed.\n\n(14) History of concurrent or prior malignancies (excluding basal cell carcinoma of the skin, in situ carcinoma of the breast\u002Fcervix, and other malignancies effectively controlled without treatment within the past five years).\n\n(15) Use of other investigational medicinal products within 30 days before screening.\n\n(16) Pregnant or lactating women of childbearing potential. Women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential.\n\n(17) Participants unwilling to use contraception from agreeing to treatment until completion of lymphocyte depletion chemotherapy or CAR-T cell infusion within 12 months (whichever is longer).\n\n(18) Any medical activities that could potentially interfere with the safety or efficacy evaluation of the study treatment.\n\n(19) According to the investigator's judgment, participants who are unlikely to complete all study visits or procedures required by the protocol (including follow-ups), or comply with the requirements of participating in the study.",{"count":358,"type":21},[296],"This study is a single-center,open-label,single-dose clinical trial of anti-CD20\u002FCD30-CAR-T cell therapy in relapsed\u002Frefractory B-cell tumor patients after lymphocyte depletion pre-treatment.\n\nIn this study phase,a traditional \"3+3\"trial design is employed for dose escalation.",[27],"2024-07-19",{"date":448,"type":38},"2024-07-25",{"date":450,"type":21},"2024-07-31",{"date":452,"type":21},"2027-07-30",{"name":454,"class":45},"Shanghai Tongji Hospital, Tongji University School of Medicine",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":462,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":46},"100544920","early-phase-1-anti-cd19-car-t-cells-in-relapsedrefractory-b-cell-tumor-patients-100544920","NCT06375161","Anti-CD19-CAR-T Cells in Relapsed\u002FRefractory B-cell Tumor Patients.","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed\u002FRefractory B-cell Tumor Patients.","Inclusion Criteria:\n\n1. Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.\n2. Age between 18-70 years.\n3. Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.\n\n   1. Relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:\n\n      \\- Primary refractory disease\n\n      \\- First relapse if the first remission was ≤12 months\n      * Relapse or refractory disease after two or more lines of systemic therapy\n      * Relapse or refractory disease after allogeneic transplantation, provided that at least 100 days have elapsed since transplantation at the time of enrollment, and no immunosuppressive drugs have been used for at least 4 weeks prior to enrollment, except for low-dose steroids (≤5 mg prednisone or equivalent).\n   2. Subjects with Ph+ B-cell ALL who are intolerant or ineligible for treatment with tyrosine kinase inhibitors (TKIs), or have relapsed\u002Frefractory disease after receiving at least two different TKI treatments, are eligible.\n   3. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (NHL) is defined as one of the following:\n\n      1. No response to first-line treatment (primary refractory disease); excluding subjects intolerant to first-line chemotherapy - PD as the best response to first-line treatment - Best response after at least 4 cycles of first-line treatment (such as 4 cycles of RCHOP) is SD, and the duration of SD after the last dose does not exceed 6 months.\n      2. No response to second-line or subsequent treatments - PD as the best response to the most recent treatment regimen - Best response after at least 2 cycles of last-line treatment is SD, and the duration of SD after the last dose does not exceed 6 months.\n      3. Refractory after ASCT\n\n         \\- Disease progression or relapse ≤12 months post-ASCT (relapse must be confirmed by biopsy).\n         * If salvage therapy is given post-ASCT, subjects must have had no response or relapse after the last-line treatment.\n4. Bone marrow smear reports showing tumor cells ≥5% in ALL patients.\n5. Patients with refractory or relapsed NHL meet one of the following subtypes:\n\n1\\) DLBCL-NOS. 2) Primary mediastinal large B-cell lymphoma (PMBCL). 3) Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into refractory disease after DLBCL.\n\n4\\) Mantle cell lymphoma. 5) High-grade B-cell lymphoma. 6) CLL\u002FSLL.\n\n(6) ECOG performance status ≤2.\n\n(7) Estimated life expectancy of at least 12 weeks.\n\n(8) Adequate venous access (for single collection) and no other contraindications to blood cell separation.\n\n(9) Laboratory test results at screening must meet the following requirements, and subjects must not have received colony-stimulating factors (G-CSF\u002FPEG-CSF) within 2 weeks prior to hematological assessment (except for low-dose steroids):\n\n1\\) Absolute neutrophil count ≥1.0×10\\^9\u002FL, ALL eligibility to be determined by the investigator.\n\n2\\) Hemoglobin ≥60 g\u002FL (without red blood cell transfusion within 14 days). 3) Platelets ≥50×10\\^9\u002FL, ALL eligibility to be determined by the investigator. 4) Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL; if insufficient, and T-cell proportion is high in the lymphocyte subset, the investigator can discuss with the sponsor.\n\n5\\) Serum total bilirubin ≤1.5× upper limit of normal (ULN). 6) Aspartate transaminase (AST), alanine transaminase (ALT) ≤2.5× ULN. 7) Creatinine \\\u003C1.5× ULN and creatinine clearance ≥60 mL\u002Fminute.\n\n(10) Left ventricular ejection fraction ≥45%, echocardiography (ECHO) confirms no clinically significant pericardial effusion (except for trace or physiological), and electrocardiography results have no clinical significance.\n\n(11) Baseline oxygen saturation in room air \\>92%.\n\n(12) Women of childbearing potential must have negative serum or urine pregnancy tests (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered women of childbearing potential).\n\nExclusion Criteria:\n\n(1) ALL with central nervous system abnormalities, excluding clinically evident neurological changes CNS-2 and CNS-3.\n\n1\\) CNS-3 disease, defined as detectable tumor cells in the cerebrospinal fluid (CSF), with ≥5 WBCs per mm3, with or without neurological changes.\n\n2\\) CNS-2 disease, defined as detectable tumor cells in the CSF, with \\\u003C5 WBCs per mm3, and neurological changes.\n\nNote: Subjects with CNS-1 (no tumor cells detected in CSF) and CNS-2 with no clinically evident neurological changes are eligible for this study.\n\n(2) Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless the central nervous system involvement has been effectively treated (i.e., participants are asymptomatic), and \\>4 weeks have elapsed since local treatment before enrollment.\n\n(3) Active central nervous system diseases such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system.\n\n(4) History of or concurrent malignancies other than CD19+ malignancies.\n\n(5) Clinically significant cardiac diseases, or arrhythmias not controlled by medication.\n\n(6) Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections, or requiring intravenous antibiotic therapy; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed if responsive to treatment and after consultation with the sponsor's medical monitor.\n\n(7) Hepatitis B (positive for hepatitis B surface antigen and\u002For positive for hepatitis B core antibody with hepatitis B DNA \\>1000 copies\u002Fml) and hepatitis C (positive for hepatitis C antibody); syphilis, human immunodeficiency virus (HIV) infection.\n\n(8) Presence of any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, indwelling Foley catheter, bile drainage tube, or pleural\u002Fperitoneal\u002Fpericardial catheter); use of dedicated central venous access devices such as Port-A-Cath® or Hickman® catheters is allowed.\n\n(9) Prior medication:\n\n1. CD19-targeted therapy.\n2. Use of chlorambucil or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.\n3. Injection of live vaccines within 4 weeks prior to enrollment.\n4. Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.\n5. Any drugs used for GVHD treatment within 4 weeks prior to enrollment (such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, or salidroside), or use of immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, or anti-interleukin-6 receptor) within 4 weeks prior to enrollment.\n6. Immunostimulatory or immunosuppressive therapy within 4 weeks prior to enrollment (such as interferon-alpha, interferon-beta, IL-2, enoxaparin, efalizumab, alemtuzumab, tacrolimus, or mycophenolate).\n7. Any systemic inhibitory\u002Fstimulatory immune checkpoint molecule therapy within 4 weeks prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).\n8. Use of systemic cytotoxic drugs within 2 weeks prior to enrollment, including daily or weekly low-dose maintenance chemotherapy (such as cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or mephalan, vincristine, etc.).\n9. Long-acting growth factors within 14 days prior to single collection (such as pegfilgrastim) or short-acting growth factors within 5 days prior to single collection or drugs used for cell mobilization (such as G-CSF\u002FPEG-CSF, plerixafor).\n10. Receipt of radiotherapy within 2 weeks prior to enrollment.\n11. Must avoid pharmacological doses of corticosteroids (\\>5 mg\u002Fday of prednisone or equivalent) and other immunosuppressive drugs within 7 days prior to single collection.\n12. Use of venetoclax (BCL-2 inhibitor) within 4 days prior to single collection.\n13. Short-acting targeted therapies (such as tyrosine kinase inhibitors) within 72 hours prior to single collection.\n14. Use of idelalisib (oral PI3Kδ inhibitor) within 2 days prior to single collection.\n15. Use of lenalidomide within 1 day prior to single collection.\n\n(10) Active graft-versus-host disease (GVHD) using CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.\n\n(11) History of autoimmune diseases in the past 2 years (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) resulting in end-organ damage or requiring systemic immunos uppressive\u002Fdisease-modifying therapy.\n\n(12) History of myocardial infarction, cardiac vascular surgery or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to enrollment.\n\n(13) History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome, etc.\n\n(14) Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within the past 6 months. Subjects need to be on prophylactic anticoagulation.\n\n(15) Past or present concurrent malignancies (excluding skin basal cell carcinoma, breast\u002Fcervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years).\n\n(16) Use of other investigational medicinal products within 30 days prior to screening.\n\n(17) Pregnant or lactating women of childbearing age, due to potential risks of chemotherapy to the fetus or infant. Women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential.\n\n(18) Subjects unwilling to practice contraception from the agreement to treatment completion of conditional chemotherapy or CAR T infusion within 12 months (whichever is longer).\n\n(19) Any medical conditions that may interfere with the safety or efficacy assessment of the study treatment.\n\n(20) Subjects unlikely, in the investigator's judgment, to complete all protocol-required study visits or procedures, including follow-up, or comply with study requirements.\n\n(21) Previous use of any CAR-T cell products or other genetically modified T cell therapies.","18 Weeks","70 Weeks",{"count":358,"type":21},[296],"This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed\u002Frefractory B-cell tumor patients after Qinglin pre-treatment.\n\nIn this study phase, a traditional \"3+3\" trial design is employed for dose escalation.",[27],"2024-04-16",{"date":470,"type":38},"2024-04-19",{"date":472,"type":38},"2023-12-11",{"date":474,"type":21},"2039-12-10",{"name":454,"class":45},{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":46},"100491790","phase-1-a-phase-1-study-to-evaluate-the-safety-and-tolerability-of-tt-01488-in-patients-with-b-cell-malignancies-100491790","NCT05683717","A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies","A Phase I, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies","Inclusion Criteria:\n\n* Participants with histologically confirmed B-cell malignancy, failed or intolerant to either ≥ 2 prior standard\u002Fcommon regimens given in combination or sequentially OR have received 1 prior BTK-containing regimen, relapse\u002Frefractory, and with treatment indication:\n\n  * CLL\u002FSLL treated with prior immunochemistry or BTK inhibitor containing regimen;\n  * DLBCL treated with prior CD20 or anthracyclines containing regimen;\n  * Other types of B-cell NHL treated with prior CD20 containing regimen\n* Adequate organ function, defined by the following laboratory parameters:\n\n  * Hematologic:\n* Absolute neutrophil count (ANC) ≥ 0.75×10\\^9\u002FL, and ≥ 0.5×10\\^9\u002FL if bone marrow involved\n* Platelets ≥ 50×10\\^9\u002FL without transfusion within 7 days, and ≥ 30×10\\^9\u002FL if bone marrow involved\n* Hemoglobin ≥ 8.0 g\u002FdL without transfusion within 7 days, and ≥ 7.0 g\u002FdL if bone marrow involved\n\n  * Coagulation:\n* Prothrombin time (PT) ≤ 1.5 × ULN\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n\n  * Renal function:\n* Creatinine clearance ≥ 30 mL\u002Fmin estimated glomerular filtration rate based on Cockcroft-Gault formula\n\n  * Liver function:\n* Total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's disease)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN unless disease-related\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to \\\u003C 2 years (Note: these cases must be discussed with the Medical Monitor and\u002For Investigator)\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days or with any of the following:\n\n  * Active graft versus host disease (GvHD);\n  * Cytopenias from incomplete blood cell count recovery post-transplant;\n  * Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n  * Ongoing immunosuppressive therapy\n* Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation",{"count":484,"type":21},37,[24],"This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.",[488],"B-Cell Malignancies","2023-11-20",{"date":491,"type":38},"2023-11-21",{"date":493,"type":38},"2023-03-30",{"date":495,"type":21},"2028-10-30",{"name":497,"class":177},"TransThera Sciences (Nanjing), Inc."]