[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-non-hodgkins-lymphoma-b-nhl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-non-hodgkins-lymphoma-b-nhl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100608727","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt801-injection-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-and-autoimmune-hemolytic-anemia-100608727",false,"NCT07205315","A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed\u002FRefractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female;\n* Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;\n* Disease progression or recurrence after at least second-line drug treatment;\n* CD19 positivity confirmed by flow cytometry and\u002For histopathology (excluding autoimmune hemolytic anemia);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);\n* Expected survival period \\> 12 weeks\n* For participants with hematological malignancies, the following requirements must be met:\n\nFor any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.\n\nFor any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.\n\n• For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg\u002Fm²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.\n\nExclusion Criteria:\n\n* Participants with a history of central nervous system leukemia\u002Flymphoma, or those with central nervous system (CNS) leukemia\u002Flymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;\n* Subjects with myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases;\n* Subjects with a history of or current comorbidities that cause coagulation disorders and high bleeding risk, such as disseminated intravascular coagulation (DIC), decompensated cirrhosis, esophagogastric varices, etc.;\n* Subjects who experienced severe bleeding (defined as bleeding uncontrollable by medication or local therapy) within 4 weeks prior to screening, or have life-threatening bleeding (associated with thrombocytopenia) currently, or are expected to require emergency treatment within one week after enrollment;\n* Subjects with secondary AIHA induced by drugs or infections;\n* Subjects with hereditary hemolytic diseases or other acquired hemolytic diseases.\n* Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;\n* If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;\n* Administration of hormonal drugs in any form within 14 days prior to infusion (except for AIHA participants requiring such drugs for hemolysis control and those receiving them for preconditioning).\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and\u002For core antibody but have HBV-DNA test results within the normal range can be included; participants who are positive for hepatitis C virus (HCV) antibody but with HCV RNA test results within the normal range are eligible for inclusion.\n* Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;\n* Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary\u002Fperipheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;\n* Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year).\n* A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression\u002Fsystemic disease-modifying agents within the past 2 years.","ALL","18 Years","75 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed\u002Frefractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.",[26,27,28,29],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","Chronic Lymphocytic Leukemia (CLL)","B-cell Non-Hodgkin's Lymphoma (B-NHL)","Autoimmune Hemolytic Anemia (AIHA)","RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-27","ACTUAL",{"date":36,"type":34},"2025-09-26",{"date":38,"type":20},"2028-08-31",{"name":40,"class":41},"Grit Biotechnology","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100491902","phase-1-a-trial-to-study-if-regn5837-in-combination-with-odronextamab-is-safe-for-adult-participants-with-aggressive-b-cell-non-hodgkin-lymphomas-100491902","NCT05685173","A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas","A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)","ATHENA-1","Key Inclusion Criteria:\n\n1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol.\n2. Measurable disease on cross sectional imaging as defined in the protocol\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n4. Adequate bone marrow, renal and hepatic function as defined in the protocol\n5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed\n6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.\n\nKey Exclusion Criteria:\n\n1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab\n2. Diagnosis of Mantle Cell Lymphoma (MCL)\n3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol\n4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol\n5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol\n6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab\n7. Co-morbid conditions, as described in the protocol\n8. Infections, as described in the protocol\n9. Allergy\u002Fhypersensitivity: Known hypersensitivity to both allopurinol and rasburicase\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply",{"count":52,"type":20},107,[54],"PHASE1","This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called \"study drug\\[s\\]\"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).\n\nThe study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab.\n\nThe goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)",[57],"B-cell Non-Hodgkins Lymphoma (B-NHL)",[59,60],"Aggressive B-Cell Non-Hodgkin Lymphomas","Relapsed or Refractory","2026-05-18",{"date":63,"type":34},"2026-05-19",{"date":65,"type":34},"2023-04-20",{"date":67,"type":20},"2030-01-13",{"name":69,"class":41},"Regeneron Pharmaceuticals",20,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100618665","phase-1-clinical-study-of-xp-006-mrna-vaccine-for-rr-b-nhl-100618665","NCT07334574","Clinical Study of XP-006 mRNA Vaccine for R\u002FR B-NHL","A Safety, Tolerability and Efficacy Study of XP-006 Personalized Tumor mRNA Vaccine for Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma","XP-006","Inclusion Criteria:\n\n1. Subjects voluntarily signed written informed consent files, able to comply with the study protocol, in the investigator's judgment.\n2. Subjects must be ≥18 years of age at time of informed consent, regardless of gender.\n3. B-NHL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma).\n4. Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons.\n5. Gene mutation and the peripheral blood HLA typing both meet the requirements of the vaccine.\n6. There are evaluable lesions detected by PET\u002FCT.\n7. Life expectancy of more than 3 months.\n8. ECOG 0-2 points.\n9. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500\u002Fmm3; Platelet count ≥75,000\u002Fmm3 ② Total bilirubin ≤2× upper limit of normal value (ULN) ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase \\[SGPT\\]) ≤3× upper limit of normal value (ULN) ④ the creatinine clearance rate was ≥60ml\u002Fmin ⑤ No cardiac dysfunction.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide);\n2. Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA \\> detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons;\n3. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;\n4. Bone marrow failure, defined as ANC\\\u003C1500\u002Fmm3 or platelet \\\u003C75,000\u002Fmm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow;\n5. Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction \\\u003C50%;\n6. Lymphoma with central nervous system (CNS) involvement;\n7. Those who are known to be allergic to the test drug ingredients;\n8. Those who have received grade II or above surgery within three weeks before treatment;\n9. Patients who have received organ transplants;\n10. Has been diagnosed with or is being treated for malignancy other than lymphoma, except for: ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment; ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment; ③ Cervical carcinoma in situ without signs of disease after adequate treatment.\n11. With severe infection;\n12. Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.",{"count":70,"type":20},[54],"The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+\u002FCD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).",[28],[84,77,85,86],"B-cell non-Hodgkin's lymphoma","Personalized","Neoantigen","NOT_YET_RECRUITING","2026-01-10",{"date":90,"type":34},"2026-01-13",{"date":92,"type":20},"2026-01-15",{"date":94,"type":20},"2029-01-01",{"name":96,"class":97},"Ruijin Hospital","OTHER",1]