[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkin-lymphomab-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkin-lymphomab-cell":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,91,115,137,157,183,209,231,251,286],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100509102","phase-2-car-t-cell-therapy-in-patients-with-renal-dysfunction-100509102",false,"NCT05909059","CAR T-cell Therapy in Patients With Renal Dysfunction","Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction","Inclusion Criteria:\n\n* Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma\n* Adequate bone marrow function to receive lymphodepleting chemotherapy\n* Renal function \\\u003C\u002F= 60mL\u002Fmin\u002F1.73m2\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Relative CNS disorders\n* Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator\n* Use of therapeutic dose systemic corticosteroids (defined as \\>20mg\u002Fday prednisone or equivalent) within 72 hours of CAR-T administration","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.",[26,27,28],"Non-hodgkin Lymphoma,B Cell","Multiple Myeloma","Acute Lymphoblastic Leukemia, Adult","RECRUITING","2026-04-15",{"date":32,"type":33},"2026-04-20","ACTUAL",{"date":35,"type":33},"2024-11-18",{"date":37,"type":20},"2027-08-31",{"name":39,"class":40},"Northside Hospital, Inc.","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"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.",{"count":50,"type":20},36,[52],"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.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,26,70,71,72,73,74,75,76,77,78,79],"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","Diffuse Large B Cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","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","2026-04-08",{"date":82,"type":33},"2026-04-14",{"date":84,"type":33},"2024-11-01",{"date":86,"type":20},"2028-12",{"name":88,"class":89},"Verismo Therapeutics","INDUSTRY",5,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100528131","sarcopenia-and-simplified-geriatric-assessment-in-lymphoma-patients-undergoing-car-t-cell-therapy-the-filsar-car-project-100528131","NCT06156774","SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old).\n* Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug\n* Availability of a 18F-FDG PET\u002FCT scan or a full dose CT scan (without contrast media) pre-treatment with CART\n* Written informed consent voluntarily provided\n\nExclusion Criteria:\n\n* Patients not fulfilling the eligibility criteria",{"count":98,"type":20},130,"OBSERVATIONAL","This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.",[26],[26,103,104],"CAR-T","Sarcopenia","2025-12-01",{"date":107,"type":33},"2025-12-08",{"date":109,"type":33},"2024-04-18",{"date":111,"type":20},"2026-07",{"name":113,"class":40},"Fondazione Italiana Linfomi - ETS",21,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100496217","phase-1-the-safety-and-efficacy-of-brl-201-in-the-treatment-of-rr-b-lymphocyte-non-hodgkin-lymphoma-100496217","NCT05741359","The Safety and Efficacy of BRL-201 in the Treatment of r\u002Fr B Lymphocyte Non-Hodgkin Lymphoma","A Phase I\u002FII Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Willing to participate in this clinical study and sign an informed consent form;\n2. Age ≥ 18 years old;\n3. Estimated survival time ≥ 3 months;\n4. Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is \\> 15 mm or the long diameter of extranodal lesions is \\> 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;\n5. Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);\n6. Relapsed or refractory diseases;\n7. Subjects who must receive adequate prior therapy;\n8. Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);\n9. Hematological parameters meeting the requirements;\n10. Blood biochemistry meeting the requirements;\n11. LVEF ≥ 55%;\n12. No severe pulmonary disorders;\n13. Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;\n14. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n15. Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;\n3. Subjects who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;\n4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;\n5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);\n6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);\n9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;\n10. Primary immunodeficiency;\n11. History of other malignancies;\n12. Patients with severe cardiovascular disorders, including but not limited to those with lymphoma infiltration in the cardiac atrium or ventricles and those with a history of myocardial infarction, cardioangioplasty or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment;\n13. History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;\n14. Patients who are receiving oral anticoagulant therapy; prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) \\> 1.5 × ULN without anticoagulant therapy;\n15. Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous nephrostomy, indwelling catheter, or catheter in pleural cavity\u002Fperitoneal cavity\u002Fpericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or Hickman catheter) are permitted;\n16. Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases, history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal fluid or brain metastases;\n17. Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses;\n18. History of severe immediate hypersensitivity to any drug to be used in this study;\n19. Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;\n20. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.",{"count":123,"type":20},18,[52],"This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.",[26],"2025-11-20",{"date":129,"type":33},"2025-11-25",{"date":131,"type":33},"2023-04-25",{"date":133,"type":20},"2027-01-15",{"name":135,"class":89},"Bioray Laboratories",3,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":41},"100612021","universal-car-t-cell-therapy-for-nhl-100612021","NCT07248163","Universal CAR-T Cell Therapy for NHL","A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r\u002Fr B Lymphocyte Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Willing to participate in this clinical study and sign an informed consent form;\n2. Age ≥ 18 years old;\n3. Estimated survival time ≥ 3 months;\n4. At least one measurable lesion;\n5. CD19 positively expressed;\n6. ECOG score 0-1；\n7. Hematology, coagulation and biochemistry parameters meeting the requirements;\n8. LVEF ≥ 55%;\n9. No severe pulmonary disorders;\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;\n3. Subjects who previously received anti-CD19 targeted therapy;\n4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;\n5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);\n6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);\n9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;\n10. Primary immunodeficiency;\n11. History of other malignancies;\n12. Patients with severe cardiovascular disorders;\n13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.",{"count":145,"type":20},6,[147],"NA","This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.",[26],"2025-11-18",{"date":129,"type":33},{"date":153,"type":33},"2025-03-11",{"date":155,"type":20},"2028-03-11",{"name":135,"class":89},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":41},"100580556","phase-1-novel-allogenic-cd19-targeting-car-t-cell-therapy-qh103e-in-rr-nhl-100580556","NCT06838832","Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r\u002Fr NHL","Novel Allogenic CD19-targeting Chimeric Antigen Receptor γδT Cells Therapy (QH103E) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Age 18-75 (inclusive).\n2. Patients with histologically confirmed CD19-positive B-cell NHL.\n3. Relapse after treatment with ≥2 lines systemic therapy for all the B-cell NHL disease types, or refractory disease for aggressive types (DLBCL-NOS, PMBCL, TFL and HGBCL). Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR to first-line therapy:\n\n   * PD as best response to first-line therapy, or\n   * SD as best response after at least 4 cycles of first-line therapy (eg,4 cycles of R-CHOP), or\n   * PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy. or refractory post-autologous stem cell transplant (ASCT): i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals); ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.\n4. The estimated survival time is over 3 months.\n5. The Eastern Cooperative Oncology Group (ECOG) score is 0-2.\n6. According to Lugano response criteria 2014, there should be at least one evaluable tumor focus. Evaluable tumor focus was defined as that with the longest diameter of intranodal focus \\> 1.5cm, the longest diameter of extranodal focus \\> 1.0cm assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\n7. Subjects must be willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.\n8. Functions of important organs meet the following requirements:\n\n   Echocardiography showed left ventricular ejection fraction ≥50%. Serum creatinine ≤1.5 × upper limit of normal range (ULN) or endogenous creatinine clearance ≥45mL\u002Fmin (cockcroft-gault formula); Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 times ULN, Total bilirubin ≤1.5× ULN; Pulmonary function: ≤CTCAE grade1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n9. Blood routine (normal values shall not be obtained with growth factors, and hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions below): hemoglobin (Hgb) ≥80g\u002FL, neutrophil count≥1×10\\^9\u002FL, platelet (PLT) ≥75×10\\^9\u002FL.\n10. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.\n11. Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion\u002Fexclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).\n12. No obvious hereditary diseases.\n13. Able to understand the requirements and matters of the trial, and willing to participate in clinical research as required.\n14. Informed consent must be signed.\n\nExclusion Criteria:\n\n1. During the screening period, there was central nervous system (CNS) invasion or a history of clinically significant central nervous system diseases, such as epilepsy and cerebrovascular diseases.\n2. Women who are pregnant or breastfeeding, or who do not agree to use effective contraception during treatment and during the subsequent 1 year.\n3. History of allogeneic hematopoietic stem cell transplantation, or organ transplantation.\n4. History of other malignancies that have not been in remission.\n5. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.\n6. Received radiotherapy within 3 months before enrollment.\n7. Received immunotherapy drugs within 4 weeks before enrollment, such as anti-programmed death 1 (PD-1) antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19\u002FCD3-bispecific antibody, and so on.\n8. Patients who received any immunocellular therapy within 6 months before enrollment.\n9. Confirmed evidence showing positiveness of anti-CD19 scFv reaction in patient serum.\n10. Patients who participated in other clinical trials within 4 weeks prior to enrollment.\n11. Uncontrolled infectious diseases or other serious illnesses, including but not limited to infections \\[e.g., human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B (HBV) or C (HCV) infection\\], congestive heart failure, unstable angina, arrhythmias, or that pose an unpredictable risk in the opinion of the attending physician.\n12. The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.\n13. A history of stroke or intracranial hemorrhage within 3 months prior to enrollment.\n14. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.\n15. Received allogeneic cell therapy within 6 weeks prior to enrollment, such as donor lymphocyte infusion.\n16. History of allergies to any of the ingredients in cell products.\n17. Conditions in which a known mental or physical illness interferes with cooperation with the requirements of the study or disrupts the results or interpretation of the results and, in the opinion of the therapeutic investigator, makes the patient unfit for study participation.\n18. There is the situation that the researcher's judgment will interfere with the whole study participation; Situations where there is significant risk to the subject; Or interferes with the interpretation of research data.\n19. Inability to understand or unwillingness to sign informed consent.\n20. Researchers believe that other reasons are not suitable for clinical trials.","75 Years",{"count":166,"type":20},30,[52,23],"CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study.\n\nThis is a single center, prospective, open-label, single-arm, phase 1\u002F2 study. A total of around 30 patients with relapsed or refractory (r\u002Fr) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive QH103E product infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of QH103E in patients with r\u002Fr B-cell NHL.",[26],[171,172,173,174],"B-cell malignancies","Relapsed or refractory","allogeneic CD19-CAR-γδT","gene editing","2025-07-27",{"date":177,"type":33},"2025-07-30",{"date":175,"type":33},{"date":180,"type":20},"2028-03-01",{"name":182,"class":40},"Chinese PLA General Hospital",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":194,"conditions":195,"keywords":196,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":41},"100571124","early-phase-1-safety-and-efficacy-of-metabolically-armed-cd19-car-t-cells-meta10-19-in-the-treatment-of-rr-b-nhl-clinical-research-100571124","NCT06716164","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r\u002Fr B-NHL Clinical Research","Inclusion Criteria:\n\n* All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;\n* Age \\> 18 years old, ≤ 70 years old, male or female;\n* Diagnosis of relapsed\u002Frefractory (R\u002FR) indolent B-cell lymphoma, and\u002For R\u002FR diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as one of the following：\n\n  1. Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or another CD20 antibody drug and at least two treatment regiments appropriate for their disease, one of which should include anthracyclines;\n  2. After treatment with these regimens, patients maintain SD (SD duration ≤ 12 months) or still progress；\n  3. Recurrence after autologous hematopoietic stem cell transplantation, or recurrence of allogeneic HSCT, or inability to accept HSCT for various reasons；\n  4. Patients with double-strike or triple-strike B-cell lymphoma who did not respond to second-line therapy；\n* CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection);\n* If the subject has progressed or relapsed after prior CD19 CAR-T cell therapy, the planned apheresis phase should be at least 1 month after that, or the subject has been treated with other biologics, but is in the washout period;\n* At least one measurable lesion at baseline, according to the Preliminary Assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition);\n* Expected survival time greater than 12 weeks;\n* ECOG score 0-1 (subjects with central nervous system diseases caused by leukemia or lymphoma need to be determined by the investigator);\n* Organ function：\n\n  1. Complete blood count (CBC) test \\[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\\]\n\n     * Lymphocyte count ≥ 0.5×109\u002FL (except for those receiving bridging chemotherapy);\n     * Platelet count ≥ 25×109\u002FL;\n     * Hemoglobin ≥ 70.0 g\u002FL\n  2. Blood Biochemistry:\n\n     * Serum creatinine (Scr) ≤ 1.5 x ULN, or\n     * endogenous creatinine clearance ≥ 40 mL\u002Fmin (using Cockcroft-Gault formula);\n     * alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n     * aspartate aminotransferase (AST) ≤ 2.5 ×ULN;\n     * Total bilirubin (TBIL) ≤ 2 ×ULN; Subjects with total bilirubin \\\u003C 3 × ULN and direct bilirubin \\\u003C 1.5× ULN with Gilbert-.Meulengracht syndrome could be included;\n     * Serum lipase and amylase ≤ 1.5×ULN;\n     * Alkaline phosphatase (ALP) ≤ 2.5 ×ULN;\n     * In case of bone or liver metastasis, AST, ALT and ALP ≤ 5 ×ULN;\n     * Prothrombin time (PT) extended ≤ 4 s, fibrinogen ≥ 1 g\u002FL, activated partial thromboplastin time (APTT) ≤ 1.5 ×ULN;\n  3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) \\> 91% in indoor air environment..\n* Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45％;\n* Patients using the following drugs must meet the following conditions:\n\n  1. Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \\\u003C 6-12mg\u002Fmm2\u002F day；\n  2. Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed;\n  3. Stop all anti-proliferation therapies other than preconditioning chemotherapy in the 2 weeks before Meta10-19 infusion；\n  4. Treatment for CNS disease must be stopped 1 week before Meta10-19 infusion (e.g., intrathecal methotrexate)\n* The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR-T cell therapy;\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo.\n\nExclusion Criteria:\n\n* Patients with present or history of central nervous system diseases not associated with leukemia or lymphoma， such as seizures disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n* Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion;\n* Patients who participated in other clinical trials within 30 days prior to enrollment;\n* Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\> 1000 copies\u002Fml) or hepatitis C (HCV RNA positive);\n* Patients with HIV antibody positive or treponema pallidum antibody positive;\n* Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion);\n* History of unstable angina and\u002For myocardial infarction within 6 months prior to signing the informed consent; History of uncontrolled thrombotic events, major bleeding, or deep venous thrombosis (DVT) within 12 months prior to signing the informed consent;\n* Patients with history of other malignancies, but the following conditions can be enrollment:\n\n  1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);\n  2. Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent；\n  3. The primary malignancy has been completely resected and in complete remission for ≥5 years；\n* Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive);\n* History of QT interval prolongation or severe cardiac disease;\n* Before signing the informed consent form, the ADA (FMC63) test was significantly positive (the test result was weakly positive, and it was necessary to discuss with the investigator whether to rule it out);\n* Other conditions that the investigator considered should not be enrolled in this clinical study.","19 Years","70 Years",{"count":50,"type":20},[193],"EARLY_PHASE1","A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Non-Hodgkin lymphoma",[26],[197,198,199],"Meta10-19","CAR-T Cells Therapy","B-cell Non-hodgkin Lymphoma","2024-11-29",{"date":202,"type":33},"2024-12-04",{"date":204,"type":20},"2024-12-01",{"date":206,"type":20},"2027-04-05",{"name":208,"class":40},"Zhejiang University",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":41},"100542749","early-phase-1-cd19-baff-car-t-cells-therapy-for-patients-with-relapsed--refractory-b-cell-all-and-b-cell-nhl-100542749","NCT06346912","CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed \u002F Refractory B-cell ALL and B-cell NHL","A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell ALL and B-cell NHL","Inclusion Criteria:\n\n* 1\\. Gender unlimited，18\\\u003C Age;\n* 2\\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma\n* 3\\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n  1. CR not achieved after standardized chemotherapy;\n  2. CR achieved following the first induction, but CR duration is less than 12 months;\n  3. Ineffectively after first or multiple remedial treatments;\n  4. 2 or more relapses;\n* 4\\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (by morphology), and\u002For \\>1% (by flow cytometry);\n* 5\\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* 6\\. Relapsed or refractory B-NHL (meeting one of the following conditions):\n\n  1. No response or relapse after second-line or above chemotherapy regimens;\n  2. Primary drug resistance;\n  3. Relapse after auto-HSCT;\n* 7\\. At least one assessable tumor lesion per Lugano 2014 criteria;\n* 8\\. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n* 9\\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* 10\\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* 11\\. Estimated survival time ≥ 3 months;\n* 12\\. ECOG performance status 0 to 2;\n* 13\\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Pregnant\u002Flactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion\n* 4\\. Patients with HIV infection;\n* 5\\. Active infection of hepatitis B virus or hepatitis C virus;\n* 6\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 7\\. Other uncontrolled diseases that were not suitable for this trial;\n* 8\\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;\n* 9\\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.",{"count":19,"type":20},[193],"Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory\u002Frelapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.",[220,26],"Acute Lymphoblastic Leukemia,B-Cell",[222],"CD19-BAFF CAR-T","2024-05-13",{"date":225,"type":33},"2024-05-14",{"date":227,"type":20},"2024-05-30",{"date":229,"type":20},"2027-05-30",{"name":208,"class":40},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":164,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100540780","phase-1-allogeneic-trac-locus-inserted-cd19-targeting-star-t-cell-therapy-in-rr-b-nhl-100540780","NCT06321289","Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r\u002Fr B-NHL","Allogeneic TRAC Locus-inserted CD19-targeting Synthetic T-cell Receptor Antigen Receptor (STAR) T Cells for Relapsed\u002FRefractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Age 18-75 (inclusive).\n2. Patients with histologically confirmed CD19-positive B-cell NHL, including the following types defined by the World Health Organization (WHO) 2016:\n\n   * Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including activated B-cell type (ABC) \u002F germinal center B-cell Type (GCB);\n   * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL);\n   * Transformed follicular lymphoma (TFL);\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (HGBCL);\n   * Follicular lymphoma (FL);\n   * Mantle cell lymphoma (MCL) \\[pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and\u002For overexpress cyclin D1\\];\n   * Marginal zone lymphoma (MZL), including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue (MALT) lymphoma.\n3. Relapse after treatment with ≥2 lines systemic therapy for all the above disease types, or refractory disease for aggressive types (DLBCL-NOS, PMBCL, TFL and HGBCL). Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR to first-line therapy:\n\n   * Evaluation of PD (never reached response or SD) after standard first-line treatment, or\n   * SD as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP), or\n   * PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy, or\n   * Refractory post-autologous stem cell transplant (ASCT): i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals); ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.\n4. Individuals must have received adequate prior therapy:\n\n   For MCL, prior therapy must have included:\n   * Anthracycline or bendamustine-containing chemotherapy and\n   * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n   * Bruton tyrosine kinase inhibitor (BTKi)\n\n   For other types, prior therapy must have included:\n   * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n   * Anthracycline containing chemotherapy regimen.\n\n   For individual with TFL must have relapse or refractory disease after transformation to DLBCL.\n5. The estimated survival time is over 3 months.\n6. The Eastern Cooperative Oncology Group (ECOG) score is 0-2.\n7. According to Lugano response criteria 2014, there should be at least one evaluable tumor focus. Evaluable tumor focus was defined as that with the longest diameter of intranodal focus \\> 1.5cm, the longest diameter of extranodal focus \\> 1.0cm assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\n8. Subjects must be willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.\n9. Functions of important organs meet the following requirements:\n\n   * Echocardiography showed left ventricular ejection fraction ≥50%;\n   * Serum creatinine ≤1.5 × upper limit of normal range (ULN) or endogenous creatinine clearance ≥45mL\u002Fmin (cockcroft-gault formula);\n   * Total bilirubin ≤1.5× ULN;\n   * Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n10. Blood routine: hemoglobin (Hgb) ≥ 80g\u002FL, neutrophil count (ANC) ≥ 1 × 10 \\^ 9\u002FL, platelet count (PLT) ≥ 75 × 10 \\^ 9\u002FL. Excluding when there is bone marrow infiltration. It is not allowed to obtain normal values through growth factor intervention.\n11. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.\n12. Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion\u002Fexclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).\n13. No obvious hereditary diseases.\n14. Able to understand the requirements and matters of the trial, and willing to participate in clinical research as required.\n15. Informed consent must be signed.\n\nExclusion Criteria:\n\n1. During the screening period, there was central nervous system (CNS) invasion or a history of clinically significant CNS diseases, such as epilepsy and cerebrovascular diseases.\n2. Women who are pregnant or breastfeeding, or who do not agree to use effective contraception during treatment and during the subsequent 1 year.\n3. History of allogeneic hematopoietic stem cell transplantation, or organ transplantation.\n4. History of other malignancies that have not been in remission.\n5. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.\n6. Received radiotherapy within 3 months before enrollment.\n7. Received immunotherapy drugs within 4 weeks before enrollment, such as anti-PD-1 antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19\u002FCD3-bispecific antibody, and so on.\n8. Confirmed evidence showing positiveness of anti-CD19 scFv reaction in patient serum.\n9. Prior CD19 targeted therapy.\n10. Prior CAR-T therapy or other genetically modified T cell therapy.\n11. Presence of DSA directed against STAR T cells.\n12. Patients who participated in other clinical trials within 4 weeks prior to enrollment.\n13. Uncontrolled infectious diseases or other serious illnesses, including but not limited to infections \\[e.g., human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B (HBV) or C (HCV) infection\\], congestive heart failure, unstable angina, arrhythmias, or that pose an unpredictable risk in the opinion of the attending physician.\n14. The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.\n15. A history of stroke or intracranial hemorrhage within 3 months prior to enrollment.\n16. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.\n17. History of allergies to any of the ingredients in cell products.\n18. Conditions in which a known mental or physical illness interferes with cooperation with the requirements of the study or disrupts the results or interpretation of the results and, in the opinion of the therapeutic investigator, makes the patient unfit for study participation.\n19. There is the situation that the researcher's judgment will interfere with the whole study participation; Situations where there is significant risk to the subject; Or interferes with the interpretation of research data.\n20. Inability to understand or unwillingness to sign informed consent.\n21. Researchers believe that other reasons are not suitable for clinical trials.",{"count":166,"type":20},[52,23],"The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r\u002Fr) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A\u002FB, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1\u002F2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r\u002Fr B-NHL.",[26],"2024-03-22",{"date":244,"type":33},"2024-03-25",{"date":246,"type":20},"2024-03-20",{"date":248,"type":20},"2027-03-20",{"name":182,"class":40},2,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":258,"maxAge":17,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":41},"100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084","NCT05518383","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)","Inclusion Criteria:\n\n* Age at diagnosis 0 to 18 years.\n* The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL\n* Informed consent of the patient parents (guardians) to be treated\n\nExclusion Criteria:\n\n* previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency\n* hypersensitivity to rituximab or to ingredients of other IMPs.\n* no informed consent of the patient parents (guardians) to be treated","1 Day",{"count":260,"type":20},300,[262],"PHASE4","The aim of the trial is to evaluate the molecular characteristics and MDD\u002FMRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET\u002FCT in assessment of the completeness of remission.\n\nThe following primary study questions are going to be analyzed:\n\n* the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by \"second-line\" block VICI in order to improve results\n\nSecondary study questions will address\n\n* additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates\n* kinetics of immune reconstitution after treatment",[26,265,266,267,268],"Burkitt Lymphoma","Primary Mediastinal Lymphoma","Primary CNS Lymphoma","Diffuse Large B-cell Lymphoma",[270,271,272,273,274,275,276],"B-cell mature non-Hodgkin's lymphoma","Burkitt's lymphoma","Diffuse large B-cell lymphoma","primary mediastinal lymphoma, primary CNS lymphoma","rituximab","children, adolescents","treatment","2022-08-25",{"date":279,"type":33},"2022-08-26",{"date":281,"type":33},"2022-05-25",{"date":283,"type":20},"2027-05-16",{"name":285,"class":40},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":293,"maxAge":164,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":41},"100403359","early-phase-1-a-study-of-humanized-cd19-car-t-cells-therapy-for-patients-with-relapsed-andor-refractory-b-cell-all-and-b-cell-nhl-100403359","NCT04532268","A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell ALL and B-cell NHL","Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Inclusion criteria only for B-ALL:\n\n  1. Male or female aged 3-70 years;\n  2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n  3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n     1. CR not achieved after standardized chemotherapy;\n     2. CR achieved following the first induction, but CR duration is less than 12 months;\n     3. Ineffectively after first or multiple remedial treatments;\n     4. 2 or more relapses;\n  4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (by morphology), and\u002For \\>1% (by flow cytometry);\n  5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* Inclusion criteria only for B-NHL:\n\n  1. Male or female aged 18-75 years;\n  2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL\u002FSLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);\n  3. Relapsed or refractory B-NHL (meeting one of the following conditions):\n\n     1. No response or relapse after second-line or above chemotherapy regimens;\n     2. Primary drug resistance;\n     3. Relapse after auto-HSCT;\n  4. At least one assessable tumor lesion per Lugano 2014 criteria;\n* Common inclusion criteria for B-ALL and B-NHL:\n\n  1. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n  2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n  3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n  4. Estimated survival time ≥ 3 months;\n  5. ECOG performance status 0 to 2;\n  6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine \\>2.5mg\u002Fdl, or ALT \u002F AST\\>3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","3 Years",{"count":295,"type":20},72,[193],"A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.",[299,26],"Acute Lymphoblastic Leukemia",[299,301,302],"Non-Hodgkin's Lymphoma","CAR T-cell therapy","2020-08-25",{"date":305,"type":33},"2020-08-31",{"date":307,"type":20},"2020-08-23",{"date":309,"type":20},"2026-08-23",{"name":208,"class":40}]