[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-large-b-cell-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,66,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100638503","early-phase-1-a-study-of-automated-axicabtagene-ciloleucel-for-rr-large-b-cell-lymphoma-100638503",false,"NCT07606937","A Study of Automated Axicabtagene Ciloleucel for R\u002FR Large B-cell Lymphoma.","A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process in Patients With Relapsed\u002FRefractory Large B-cell Lymphoma.","Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent\n2. Has signed the informed consent form (ICF)\n3. Histologically proven large B-cell lymphoma\n4. Relapsed or refractory disease after first-line chemoimmunotherapy\n5. The subject has at least one measurable lesion on imaging\n6. No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)\n7. A washout period of at least 2 weeks or 5 half-lives (whichever is shorter) from the last prior systemic therapy to the signing of the informed consent form.\n8. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1\n9. ECOG performance status of 0 or 1\n10. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function\n11. Female subjects of childbearing potential must have a negative serum pregnancy test . Male and female subjects of childbearing potential must agree to use highly effective contraception during the study and for 6 months post-infusion.\n\nExclusion Criteria:\n\n1. Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years.\n2. History of Richter's transformation of CLL or PMBCL\n3. History of autologous or allogeneic stem cell transplant\n4. Received more than one line of therapy for DLBCL\n5. Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel\n6. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy\n7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab\n8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management\n9. Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive)\n10. Active tuberculosis\n11. Presence of any indwelling line or drain\n12. Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases\n13. History or presence of non-malignant CNS disorder\n14. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement\n15. History of clinically significant cardiac disease within 12 months of enrollment\n16. Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction\n17. Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded.\n18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n19. Women of childbearing potential who are pregnant or breastfeeding\n20. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r\u002Fr LBCL) as second-line therapy.",[26],"Relapsed\u002FRefractory Large B-cell Lymphoma","RECRUITING","2026-06-02",{"date":30,"type":31},"2026-06-05","ACTUAL",{"date":33,"type":20},"2026-06-12",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Shenzhen Fosun Kairos Biotechnology Co., Ltd.","INDUSTRY",6,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100500801","phase-1-a-study-of-c-car039-prizloncabtagene-autoleucel-in-patients-with-relapsedrefractory-large-b-cell-lymphoma-100500801","NCT05800977","A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1b\u002F2 Study of a Anti-CD19\u002FCD20 Bispecific CAR-T Therapy (C-CAR039\u002FPrizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","ELEVATION","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:\n\n  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)\n  2. Primary mediastinal large B-cell lymphoma (PMBCL)\n  3. Transformed follicular lymphoma (tFL)\n  4. High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements (HGBL-DH\u002FTH)\n  5. High-grade B-cell lymphoma, NOS (HGBL, NOS)\n  6. Follicular lymphoma grade 3B (FL3B)\n* Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)\n* At least one measurable lesion per the Lugano 2014 Classification\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis\n* Suspected or confirmed central nervous system involvement\n* Stroke or convulsion history within 6 months of signing informed consent form (ICF)\n* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment\n* Uncontrolled active infection\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test\n* Severe heart, liver, renal or metabolism disease\n* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis\n* Prior CAR-T therapy",{"count":49,"type":20},112,[51,52],"PHASE1","PHASE2","This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).",[55],"Relapsed\u002FRefractory Large B-Cell Lymphoma","2025-12-23",{"date":58,"type":31},"2025-12-31",{"date":60,"type":31},"2023-02-22",{"date":62,"type":20},"2028-06-30",{"name":64,"class":38},"Shanghai AbelZeta Ltd.",15,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":39},"100547913","phase-2-mrd-directed-consolidation-with-epcor-only-or-epcor-r2-post-anti-cd19-car-tcell-therapy-for-large-b-cell-lymphoma-100547913","NCT06414148","MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma","A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART)","EpLCART","Inclusion Criteria\n\n1. Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n3. A diagnosis of relapsed\u002Frefractory large B-cell lymphoma\n4. Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.\n5. Partial metabolic response (PMR) or complete metabolic response (CMR) as per the Lugano criteria on the most recent PET\u002FCT performed at any point between Day +25 and Day +100 post CAR T-cell infusion, when compared with the most recent PET\u002FCT prior to CAR T-cell infusion.\n6. MRD positive by a ctDNA assay on a blood sample taken at any point between Day +25 and Day +100 post CAR T-cell infusion.\n7. Adequate haematological function documented within 7 days prior to randomisation\n8. Adequate cardiac function.\n9. Adequate renal function, documented within 7 days prior to randomisation\n10. Adequate hepatic function documented within 7 days prior to randomisation\n11. Complete resolution of cytokine release syndrome (CRS), macrophage-activation syndrome (MAS)\u002Fhaemophagocytic lymphohistiocytosis (HLH) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to prior CAR T-cell therapy.\n12. Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method\u002Fprocedure as outline in the PICF\n13. Sexually active males must agree to use a condom during sexual contact with a pregnant female or a FCBP for the course of the study through to 4 months after the last dose of epcoritamab, even if he has undergone a successful vasectomy\n14. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of epcoritamab\n15. The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol\n\nExclusion Criteria\n\n1. A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy\n2. Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy\n3. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment\n4. Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20\n5. A diagnosis of primary central nervous system (CNS) lymphoma\n6. Active secondary CNS involvement of lymphoma at time of screening\n7. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression\n8. Known cognitive impairment would place the patient at increased risk of complications from ICANS\n9. A known history of hepatitis B serology consistent with acute or chronic infection\n10. A known history of hepatitis C serology consistent with acute or chronic infection\n11. A known history of testing positive for human immunodeficiency virus (HIV)\n12. Any comorbidity conferring a life expectancy of \\\u003C 5 years (e.g., second malignancy) or that in the opinion of the site investigator may significantly impact the ability to complete the trial therapy and follow-up or affect the interpretation of results\n13. Exposed to live or live attenuated vaccine within 4 weeks prior to signing the PICF.\n14. Women who are pregnant or lactating\n15. Known hypersensitivity to epcoritamab, lenalidomide, rituximab, tocilizumab or their excipients\n16. Presence of any psychological, social or geographical or other condition for which participation would not be in the best interest of the patient","16 Years",{"count":76,"type":20},40,[52],"This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.",[26],[81,82,83,84,85,86,87,88,89,90,91],"Minimal Residual Disease","Large B-Cell Lymphoma","Anti-CD19","CAR T","ctDNA","Lymphoma","DLBCL","HGBL","Epcoritamab","Lenalidomide","Rituximab","2025-06-04",{"date":94,"type":31},"2025-06-05",{"date":96,"type":31},"2024-05-14",{"date":98,"type":20},"2028-05",{"name":100,"class":101},"Peter MacCallum Cancer Centre, Australia","OTHER",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100553724","phase-2-linperlisib-combined-with-immunochemotherapy-in-relapsedrefractory-lbcl-100553724","NCT06489808","Linperlisib Combined With Immunochemotherapy in Relapsed\u002FRefractory LBCL","An Open-label, Multicenter, Multi-cohort Clinical Study of Linperlisib Combined With Standard Immunochemotherapy in the Treatment of Relapsed\u002FRefractory Large B-Cell Lymphoma Failing to First-line Therapy","Inclusion Criteria:\n\n1. Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), follicular lymphoma grade 3B (FL, 3B), high-grade B-cell lymphoma unspecified (HGBCL, NOS), DLBCL\u002FHGBCL with MYC and BCL2 rearrangements, FL transformed DLBCL without a previous history of indolent lymphoma.\n2. Relapsed or refractory after first-line immunochemotherapy (which must include CD20 monoclonal antibody and anthracycline) 1)Refractory is defined as failure to achieve a complete response to first-line therapy (excluding patients who are intolerant to first-line therapy), including progressive disease (PD) as the best response to first-line therapy; stable disease (SD) as the best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP); partial response (PR) as the best response after at least 6 cycles of first-line therapy with biopsy-confirmed residual disease or disease progression within 12 months of initiating first-line therapy; complete response to first-line therapy followed by progression within 12 months after the end of therapy. 2)Relapse was defined as a complete response to first-line therapy followed by progression confirmed more than 12 months after the end of therapy.\n3. Subjects must have at least 1 measurable lesion\u002Fevaluable lesion that meets the 2014 version of the Lugano Lymphoma Evaluation Criteria.\n4. Subjects has no known or suspected central nervous system involvement by lymphoma.\n5. Previous treatment with any antineoplastic therapy (including radiation therapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy) for which participation in this trial must have exceeded 2 weeks or 5 drug half-lives, whichever is shorter.\n6. Age ≥ 18 years.\n7. ECOG score 0-2.\n8. Expected survival ≥ 3 months.\n9. Women of Childbearing Potential subjects must have a negative serum\u002Furine pregnancy test within 7 days prior to the first dose; female subjects of childbearing potential and male subjects with partners of childbearing potential, as well as their partners, should agree to use effective contraception from signing the ICF until 6 months after the last dose of study drug.\n10. Able to comply with the trial protocol as judged by the investigator.\n11. Each subject (or legally acceptable representative) voluntarily joined the study and signed an informed consent form.\n\n    \\-\n\nExclusion Criteria:\n\n1. Other malignancies within the last 5 years, except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix.\n2. Previous autologous or allogeneic hematopoietic stem cell transplantation.\n3. History of Richter transformation.\n4. Received \\> 1 line of systemic antineoplastic therapy.\n5. Prior treatment with PI3K inhibitors.\n6. Known hypersensitivity to trial products.\n7. Active viral, bacterial, or fungal infection requiring treatment (eg, pneumonia, etc.).\n8. Requiring prolonged systemic hormones (at doses equivalent to \\> 10 mg prednisone\u002Fday) or any other form of immunosuppressive therapy. Subjects taking inhaled or topical corticosteroids may be enrolled.\n9. Concomitant diseases and medical history:\n\n   1. Multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, ileus, etc.).\n   2. Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders.\n   3. Subjects with any severe and\u002For uncontrolled disease including:\n\n      1)Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg). 2)Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 450 ms (male), QTc ≥ 470 ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification). 3)Active interstitial pneumonia or other chronic lung disease resulting in severely impaired lung function defined as FEV1 and DLCOc \\\u003C 60% of predicted normal; history of interstitial pneumonia due to COVID-19. 4)Abnormal liver: I.Decompensated cirrhosis (Child-Pugh class B or C). II.Known history of clinically significant liver disease. 5)Renal failure requiring hemodialysis or peritoneal dialysis. 6)Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 7)Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein quantification \\> 1.0 g.\n   4. Patients with active or history of autoimmune diseases that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk. Patients with autoimmune hypothyroidism requiring only hormone replacement therapy may be considered for enrollment if the disease is stable as assessed by the investigator.\n10. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome.\n11. Positive pregnancy test at baseline in female patients who are pregnant, lactating, or of childbearing potential.\n12. Concurrent medical conditions that, in the investigator 's judgment, would seriously compromise the patient' s safety or the patient 's completion of the study.\n\n    \\-",{"count":110,"type":20},89,[52],"To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R\u002FR LBCL.",[55],[115,116],"Linperlisib","Immunochemotherapy","2024-07-04",{"date":119,"type":31},"2024-07-08",{"date":121,"type":31},"2024-05-28",{"date":123,"type":20},"2027-05-31",{"name":125,"class":101},"Institute of Hematology & Blood Diseases Hospital, China",1]