[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hgbl-with-myc-and-bcl2-andor-bcl6-rearrangements\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hgbl-with-myc-and-bcl2-andor-bcl6-rearrangements":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"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":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911",false,"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.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"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","Non-hodgkin Lymphoma,B Cell","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","RECRUITING","2026-04-08",{"date":55,"type":56},"2026-04-14","ACTUAL",{"date":58,"type":56},"2024-11-01",{"date":60,"type":20},"2028-12",{"name":62,"class":63},"Verismo Therapeutics","INDUSTRY",5,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"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":75,"type":20},18,[23],"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.",[79,80,44,81,36,82],"Diffuse Large B-cell-lymphoma","DLBCL, Nos Genetic Subtypes","PMBL","HGBL, Nos",[84,85,86,87,88],"autologous fast CAR-T","CD19","B cell lymphoma","subcutaneous injection","without lymphodepletion","2025-06-11",{"date":91,"type":56},"2025-06-13",{"date":93,"type":56},"2025-03-19",{"date":95,"type":20},"2026-05-11",{"name":97,"class":63},"Shanghai Exuma Biotechnology Ltd.",1]