[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"follicular-lymphoma-grade-3b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:follicular-lymphoma-grade-3b":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,99,133,160,182],{"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":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629548","geriatric-guided-care-versus-conventional-care-in-elderly-unfitfrail-patients-with-diffuse-large-b-cell-lymphoma-in-first-line-treatment-100629548",false,"NCT07476105","Geriatric-guided Care Versus Conventional Care in Elderly Unfit\u002FFrail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment","Geriatric-guided Care Versus Conventional Care in Elderly Unfit\u002FFrail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment. The Elderly Project 2.0: Non-randomized Cluster Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.\n2. Age ≥ 70 years.\n3. UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.\n4. Patients eligible to a curative intent standard first line chemoimmunotherapy.\n5. Ability to understand and willingness to comply with study procedures.\n6. Signature of a written informed consent.\n\nExclusion Criteria:\n\n1. Patients not meeting at least one of the inclusion criteria listed above.\n2. Refuse to sign a written informed consent.","ALL","70 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative\u002Fnutritional plan for elderly unfit\u002Ffrail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone.\n\nA key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit\u002Ffrail DLBCL patients.\n\nThis study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.",[26,27],"Diffuse Large B Cell Lymphoma","Follicular Lymphoma Grade 3B",[26,27,29,30,31,32,33,34,35,36],"unfit","frail","cluster","R-CHOP","geriatric","sGA","elderly","caregiver","NOT_YET_RECRUITING","2026-04-14",{"date":40,"type":41},"2026-04-15","ACTUAL",{"date":43,"type":20},"2026-05",{"date":45,"type":20},"2029-05",{"name":47,"class":48},"Fondazione Italiana Linfomi - ETS","OTHER",24,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","18 Years",{"count":59,"type":20},36,[61],"PHASE1","This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[64,65,66,67,68,69,70,71,72,73,74,75,26,76,77,78,79,80,27,81,82,83,84,85,86,87],"B Cell Lymphoma","NHL, Adult","Mantle Cell Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","High-grade B-cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","DLBCL","Waldenstrom Macroglobulinemia","Waldenstrom Macroglobulinaemia","RECRUITING","2026-04-08",{"date":38,"type":41},{"date":92,"type":41},"2024-11-01",{"date":94,"type":20},"2028-12",{"name":96,"class":97},"Verismo Therapeutics","INDUSTRY",5,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100579879","phase-1-clinical-study-of-c402-cd19-car-treatment-in-subjects-with-relapsed-or-refractory-b-cell-lymphoma-100579879","NCT06830031","Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma","A Phase 1 Study of C402-CD19-CAR, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Targeting CD19 in Subjects With Relapsed or Refractory Large B-cell Lymphoma","C402","Inclusion Criteria:\n\nMust meet all the following inclusion criteria:\n\n1. Male or female 18-75 years (inclusive);\n2. Patients can understand this study and capable of providing informed consent;\n3. Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements;\n4. Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), grade 3b follicular lymphoma (FL), transformed diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBL), high-grade B-cell lymphoma (HGBL) with MYC, BCL-2, and\u002For BCL-6 rearrangements, and high-grade B-cell lymphoma not otherwise specified (HGBL-NOS). For CD19 expression status, subjects with a clear past record of tumor histological diagnosis as CD19-positive (within 6 months prior to screening with no CD19-related treatment in the last 6 months) and tumors showing CD19-positive lymphoma levels ≥ 50% by IHC or CD19-positive lymphoma levels ≥ 70% by flow cytometry. If there is no previous CD19 tumor testing or the result is over 6 months prior to screening, a new tumor pathology sample must be provided or re-collected for CD19-positive diagnosis by the institution, with IHC showing CD19-positive lymphoma levels ≥ 50% or flow cytometry showing CD19-positive lymphoma levels ≥ 70%.\n5. For refractory or relapsed large B-cell lymphoma subjects, must have received at least anthracycline-based therapy and rituximab (or other CD20-targeted drugs, excluding CD20-negative cases). If previously treated with R-CHOP or other CD20-targeted therapy, the best treatment outcome prior to relapse must have been complete remission (CR). Subjects should meet the criteria for relapse, progression, or failure after second-line therapy; or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT). If the subject has undergone previous auto-HSCT, the best treatment outcome prior to relapse must have been CR, and the relapse should occur more than 12 months after the previous treatment. (Refractory is defined as the best response to the most recent treatment being disease progression or stable disease after at least 2 cycles of the last-line therapy).\n6. According to the 2014 Lugano Treatment Response Assessment Criteria, at least one measurable tumor lesion should be present (lesions can be measured with PET results; lymph node lesions \\[long axis LDi \\> 15mm\\] or extra nodal lesions \\[long axis LDi \\> 10mm\\]);\n7. Expected survival time greater than 12 weeks;\n8. ECOG score of 0-1;\n9. Able to establish an intravenous route for PBMC collection, meeting the following hematologic parameters before screening: Hemoglobin ≥ 80 g\u002FL, absolute neutrophil count ≥ 1.0 × 10\\^9\u002FL, platelet count ≥ 75 × 10\\^9\u002FL, lymphocyte count ≥ 0.5 × 10\\^9\u002FL (if using bone marrow stimulants or blood transfusion, a washout period of 7 days is required; for granulocyte colony-stimulating factor \\[G-CSF\\] or granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], a washout period of 4 weeks or 5 half-lives is required);\n10. Liver and kidney function, as well as heart and lung function, should meet the following requirements:\n\n    1. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula);\n    2. Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected;\n    3. Oxygen saturation ≥ 92% without oxygen support;\n    4. Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN);\n    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;\n    6. Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;\n11. No more than 1 month prior to screening, the subject must have participated in another interventional clinical study and recovered to a severity level of ≤ 1 for any treatment-related adverse events.\n\nExclusion Criteria:\n\n1. History of receiving allogeneic hematopoietic stem cell transplantation, adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell therapies;\n2. Any active central nervous system (CNS) involvement (including symptomatic and asymptomatic), or a history of CNS disease (such as epilepsy, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the CNS);\n3. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA positivity, or subjects with HBV titers above the upper limit of the normal range for the study center; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA positivity; positive for cytomegalovirus (CMV) DNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;\n4. Any unstable systemic disease, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ III), active bleeding, severe arrhythmias requiring drug treatment, liver, kidney, or metabolic disorders;\n5. Presence of malignant tumors other than large B-cell lymphoma, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, and other cancers with a disease-free survival of more than 5 years;\n6. Presence of gastric lymphoma, bulky disease, a history of CD19+ leukemia, or active autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.);\n7. Presence of uncontrolled active infections requiring treatment (e.g., sepsis, bacteremia, fungemia, viremia) (mild urinary tract infections or upper respiratory tract infections are exceptions), with the exception of prophylactic anti-infection treatment (for bacterial, fungal, viral infections, etc.);\n8. Subjects who have received systemic steroid treatment within 2 weeks before PBMC collection and are determined by the investigator to require long-term systemic steroid treatment during the treatment period (except for inhaled, local application, or physiological replacement doses \\[hydrocortisone ≤7 mg·d-1 or equivalent prednisone ≤5 mg·d-1 or dexamethasone ≤0.5 mg·d-1\\]);\n9. Subjects who have received anti-tumor treatment within 8 weeks or 5 half-lives (specific medications need to be assessed in detail) before PBMC collection, including chemotherapy, CD20-targeted therapy, etc.; local radiotherapy within 12 weeks;\n10. Subjects who have used granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks before PBMC collection or within at least 5 half-lives (whichever is shorter);\n11. Subjects who have received alendronate treatment within 6 months before PBMC collection, or who have received fludarabine, cladribine, or bendamustine treatment within 3 months before PBMC collection;\n12. Subjects who have undergone major surgery within 4 weeks prior to screening (as defined by \"Clinical Application Measures of Medical Technology\" and \"Grade 3 and 4 surgeries\") or who have not fully recovered from any previous invasive procedure;\n13. Subjects who have received a live vaccine within 28 days before PBMC collection;\n14. Pregnant or breastfeeding women, or those who plan to become pregnant during the treatment period or within 2 years after treatment, or male subjects whose partners plan to become pregnant within 2 years after male subject's cell injection;\n15. Subjects whom the investigator deems unsuitable to participate in this trial.","75 Years",{"count":109,"type":20},18,[61],"This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.",[113,114,27,115,74,116],"Diffuse Large B-cell-lymphoma","DLBCL, Nos Genetic Subtypes","PMBL","HGBL, Nos",[118,119,120,121,122],"autologous fast CAR-T","CD19","B cell lymphoma","subcutaneous injection","without lymphodepletion","2025-06-11",{"date":125,"type":41},"2025-06-13",{"date":127,"type":41},"2025-03-19",{"date":129,"type":20},"2026-05-11",{"name":131,"class":97},"Shanghai Exuma Biotechnology Ltd.",1,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":98},"100468248","long-term-follow-up-study-of-lentiviral-based-gene-edited-immune-cell-therapy-100468248","NCT05377307","Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy","Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy","Inclusion Criteria:\n\n1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.\n2. The last lentiviral-based gene-edited immune cell infusion within 15 years.\n3. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for this study.",{"count":141,"type":20},49,"OBSERVATIONAL","According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.",[26,76,145,146,27],"Primary Mediastinal Large B Cell Lymphoma","Follicular Lymphoma Grade 3A",[148,149,150],"DLBCL(Diffuse Large B Cell Lymphoma)","PMLBCL(Primary Mediastinal Large B Cell Lymphoma)","FL(Follicular Lymphoma)","2025-05-07",{"date":153,"type":41},"2025-05-13",{"date":155,"type":41},"2022-12-29",{"date":157,"type":20},"2037-12",{"name":159,"class":97},"Pell Bio-Med Technology Co., Ltd.",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":98},"100464326","phase-1-phase-12-study-of-cd19-chimeric-antigen-receptor-t-cell-cd19-car-t-pl001-for-relapsed-or-refractory-b-cell-lymphoma-100464326","NCT05326243","Phase 1\u002F2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma","A Phase 1\u002F2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\nScreening 1:\n\n1. Patient is ≥14 years of age, inclusive, at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMLBCL), large B-cell lymphoma transformed from follicular lymphoma (FL), or grade 3a or 3b FL.\n3. On-site documentation of CD19 on the dominant population of cancer cells.\n4. Disease status should meet any one of the below:\n\n   1. Patients with previous autologous-hematopoietic stem cell transplantation (auto HSCT) have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after transplantation regardless of lines of systemic therapy.\n   2. Patients without previous HSCT have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after at least 2 lines of systemic therapy, including anti-CD20 antibody and anthracycline.\n5. Have no available effective systemic therapy as judged by the Investigator.\n6. At least one measurable non-CNS (central nervous system) lesion based on Lugano classification for lymphoma.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n8. Life expectancy of at least 3 months.\n9. Patient is male or female.\n10. A male patient must agree to use a highly effective contraception as detailed in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating sperm during this period.\n\n    Female Patients:\n11. A female patient is eligible to participate if she is not pregnant (Section 10.4; Appendix 4), not breastfeeding, and at least one of the following conditions applies:\n\n    • Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 (Appendix 4).\n\n    OR\n\n    • A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating ova during this period.\n12. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nScreening 2:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n2. CAR-T is successfully manufactured and ready for use, from cells harvested by non mobilized leukapheresis.\n3. WOCBP who have a negative serum pregnancy test at Screening 2.\n\nExclusion Criteria:\n\nScreening 1:\n\n1. Chronic lymphocytic leukemia with Richter's transformation.\n2. Primary CNS lymphoma. (Non-primary CNS lymphoma with CNS involvement is eligible).\n3. Primary intra-ocular lymphoma.\n4. Prior CD19 targeted therapy, such as CAR-T, Bi-specific T-cell engagers (BiTE), or monoclonal antibody.\n5. History of cancers (includes myelodysplastic syndrome) other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free without active treatment for at least 3 years.\n6. History of allogeneic HSCT.\n7. History of autologous HSCT within 3 months prior to consent.\n8. Received any investigational product within 4 weeks prior to consent.\n9. Systemic anticancer therapy within 3 weeks prior to apheresis.\n10. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent, within 2 weeks prior to leukapheresis.\n\n    Exception examples:\n    * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n    * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n    * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n11. Use of long-acting and short-acting myeloid growth factor within 2 weeks, 5 days prior to leukapheresis, respectively.\n12. Received anti-thymocyte globulin within 4 weeks prior to consent.\n13. Intrathecal chemotherapy within 1 week prior to leukapheresis.\n14. Inadequate major organ functions at Screening, which were defined as any of below:\n\n    1. absolute neutrophil count (ANC) \\\u003C500\u002FµL\n    2. Absolute lymphocyte count (ALC) \\\u003C300\u002FµL, excluding leukemic cells.\n    3. Hemoglobin (Hb) \\\u003C8.0 g\u002FdL\n    4. Platelet count \\\u003C75,000\u002FµL without transfusion support within 3 days\n    5. e. Baseline O2 saturation \\\u003C92% by pulse oximetry at room air\n    6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n    7. Aspartate aminotransferase (AST) \\>5 × upper limit of normal (ULN) and alanine aminotransferase (ALT) \\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n    8. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n    9. Significant cardiac disease including but not limited to: left ventricular ejection fraction (LVEF) \\\u003C50%, QTc(the corrected QT interval) \\> 480 msec based on Fredericia's formula, clinically significant arrhythmias, history of myocardial infarction or unstable angina within 3 months prior to consent.\n15. Active hepatitis B virus (HBV) infection defined as detectable HBV DNA (Patients with positive anti-hepatitis B core antibody \\[HBcAb\\] must consent to regular monitoring of HBV DNA, and anti-HBV prophylaxis with oral anti-viral agent (such as entecavir) is mandatory until End-of-Study visit \\[Visit 15\\].)\n16. Active hepatitis C virus (HCV) infection defined as positive anti- HCV antibody plus detectable HCV RNA.\n17. Positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) infection.\n18. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to apheresis).\n\n21\\. Any medical conditions which might compromise the patient's safety from leukapheresis, lymphodepletion chemotherapy, or CAR-T therapy and anticipated AEs, according to the Investigator's evaluation.\n\n22.Patients with insufficient leukapheresis cells.\n\nScreening 2:\n\n1. Inadequate major organ functions at Screening which were defined as any of below:\n\n   1. ANC \\\u003C500\u002FµL\n   2. Hb \\\u003C8.0 g\u002FdL\n   3. Platelet count \\\u003C50,000\u002FµL, without transfusion support within 3 days\n   4. Baseline O2 saturation \\\u003C92% by pulse oximetry on room air\n   5. AST \\>5 × ULN and ALT\\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n   6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n   7. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n2. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent.\n\n   Exception examples:\n   * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n   * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n   * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n3. Use of long-acting and short-acting myeloid growth factor within 12 days, 2 days prior to lymphodepletion therapy, respectively.\n4. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g. the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to lymphodepletion).\n5. Any medical condition which might compromise the patient's safety because of lymphodepletion chemotherapy or CAR-T therapy and anticipated AEs, according to the Investigator's opinion.","14 Years",{"count":141,"type":20},[61,170],"PHASE2","This is a multiple center, non-randomized, open-label, phase 1\u002F2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).",[26,145,76,146,27],[85,174,175],"PMLBCL","FL",{"date":153,"type":41},{"date":178,"type":41},"2022-05-31",{"date":180,"type":20},"2027-03-31",{"name":159,"class":97},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":107,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":132},"100442374","r-cdop-regimen-in-the-treatment-of-newly-diagnosed-non-hodgkins-lymphoma-with-high-tumor-burden-100442374","NCT05040555","R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden","A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden","Inclusion Criteria:\n\n1. Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;\n2. Has at least one evaluable or measurable lesion according to Lugano response criteria;\n3. Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass \\> 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female \\> 15cm, male \\> 16cm); Pleural\u002Fperitoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV \\>220cm3;\n4. Patients previously untreated;\n5. Patients aged over 18 and under 75 years;\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0\\~2;\n7. International Prognostic Index (IPI) score \\> 1, or with extranodal mass diameter ≥7cm;\n8. Life expectancy ≥ 6 months;\n9. Left Ventricular Ejection Fraction (LVEF) ≥ 50%;\n10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.\n\nExclusion Criteria:\n\n1. Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;\n2. Abnormal liver function \\[total bilirubin \\> 1.5 times of the upper limit of normal value; Alanine aminotransferase\u002FAspartate aminotransferase (ALT \u002F AST) \\> 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT \u002F AST \\> 5 times of upper limit of normal value for patients with liver metastasis \\], abnormal renal function (serum creatinine \\> 1.5 times of upper limit of normal value) ;\n3. Absolute Neutrophil Count (ANC)\\\u003C1.5×10\\^9\u002FL or Platelet (PLT)\\\u003C 75 × 10\\^9\u002FL;\n4. Hypersensitivity to any study drug or its ingredients;\n5. Patients with significant and uncontrolled cardiovascular disease or history;\n6. Persons with mental disorders\u002Funable to obtain informed consent;\n7. Lymphoma infiltrates the central nervous system;\n8. Previous history of malignant tumor;\n9. HIV infection; HBV infection (HBV-DNA\\> 2000 IU\u002Fml);HCV infection (HCV-RNA\\>200 IU\u002Fml);\n10. The investigator determined not suitable to participate in this study.",{"count":190,"type":20},64,[23],"A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.",[26,27],"2021-09-15",{"date":196,"type":41},"2021-09-16",{"date":198,"type":41},"2021-08-30",{"date":200,"type":20},"2028-09-01",{"name":202,"class":48},"oubai, MD\u002FPhD"]