[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-non-hodgkin-lymphoma-b-nhl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-non-hodgkin-lymphoma-b-nhl":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,78],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100446836","phase-1-preliminary-safety-and-tolerability-of-cd19x22-car-t-cells-in-adolescent-and-adult-rr-b-nhl-patients-100446836",false,"NCT05098613","Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R\u002FR B-NHL Patients","Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and\u002For Refractory B-Non-Hodgkin's Lymphoma (B-NHL)","Inclusion Criteria:\n\n1\\. Age: ≥ 16 years of age with no upper age limit. (NOTE: the first three subjects on this trial must be ≥ 18 years of age.)\n\nCOHORT 1: Non-CNS B-NHL\n\n1. Histologically confirmed aggressive B-cell NHL including the following types defined by World Health Organization (WHO) 2008:\n\n   a. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr Virus (EBV)+ DLBCL of the elderly; OR b. Primary mediastinal (thymic) large B cell lymphoma; OR c. Transformation to DLBCL; OR d. High grade B-cell Lymphoma (HGBL).\n2. Subjects must not have any signs or symptoms of CNS disease or detectable evidence of CNS disease on magnetic resonance imaging (MRI) at screening; subjects who have been previously treated for CNS disease, but have no evidence of disease at screening are eligible for this cohort.\n3. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least two lines of therapy.\n\n   a. The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment.\n\n   b. Relapse or refractory after single antigen targeting CAR T cell therapy\n4. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\nCOHORT 2: MANTLE CELL LYMPHOMA (MCL)\n\n1. Mantle Cell Lymphoma (MCL).\n\n   a. Results of all tests conducted on the tissue at initial diagnosis and\u002For relapse, including, but not limited to, the MCL subtype (classic and blastoid), Ki-67 proliferation index, and TP53 mutation status should be provided if done.\n2. Subjects must have relapsed and\u002For refractory MCL confirmed by either flow cytometry or immunohistochemistry (ICH), disease stabilization, or disease recurrence after at least two lines of therapy including any combination of the agents below:\n\n   a. An anti-CD20-directed therapy b. A BTK inhibitor c. Anthracycline or Bendamustine d. Relapse or refractory after single antigen targeting CAR T cell therapy.\n3. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. MCL patients without measurable nodal or extranodal disease by IWG criteria are eligible if they have bone marrow involvement of MCL at relapse\n\nCOHORT 3: PRIMARY CNS LYMPHOMA OR SECONDARY CNS LYMPHOMA\n\n1. Subjects with relapsed and\u002For refractory primary CNS lymphoma (PCNSL) OR secondary CNS lymphoma (SCNSL), as defined by the following:\n\n   a. Absence of measurable disease outside the CNS, as determined by radiographic imaging (i.e. PET\u002FCT).\n\n   b. Detectable CNS disease, as defined as: i. At least 1 site of measurable disease within the brain or spinal cord that is ≥ 1 cm in the longest diameter based on MRI or PET\u002FCT imaging; OR, ii. Neoplastic B-cells detectable within the CSF or vitreous by flow cytometry or cytology.\n2. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least one line of therapy.\n\nALL COHORTS:\n\n1. Subjects who have undergone autologous stem cell transplantation (SCT) with disease progression or relapse are eligible.\n2. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, are:\n\n   1. At least 100 days post-transplant,\n   2. Do not have active graft versus host disease (GVHD)\n3. Any standard of care systemic therapy prior to leukapheresis must follow the washout period.\n4. Any steroid use (dexamethasone or prednisone) prior to apheresis must follow the washout period. Physiological replacement doses are allowable with no washout period. Topical or inhaled steroids for localized GVHD is allowable.\n5. Peripheral blood CD3 count must be \\>0.15 x 10 (to the 6th) cells\u002FmL within 14 days prior to proceeding with apheresis.\n6. Toxicities from prior therapy must be stable and recovered to ≤ grade 1 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in inclusion criteria 12).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Karnofsky ≥ 80%.\n8. Adequate organ function as defined by:\n\n   1. Absolute neutrophil count (ANC) ≥ 500\u002FμL\n   2. Platelet count ≥ 50,000\u002F μL.\n   3. Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n   4. Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n   5. Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C4.0 will be acceptable.\n   6. Cardiac: Ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings within 6 weeks of apheresis.\n   7. Pulmonary: No clinically significant pleural effusion and;\n\n   i. Baseline oxygen saturation must be \\> 92% on room air\n9. Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be of childbearing potential).\n10. Subjects of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the CD19x22 infusion; females of childbearing potential must have a negative pregnancy test.\n\n21\\. Must be able to give informed consent; subjects unable to give informed consent will not be eligible for this study.\n\n22\\. Be able to consent to long-term follow-up protocol (#20-0188).\n\nExclusion Criteria:\n\n1. Age \\\u003C 16 years of age.\n2. Patient who is intolerant of contrast-enhanced MRI due to allergic reactions to contrast agents. Only applicable to Cohort 3.\n3. History of other malignancies, unless they have been disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ and localized prostate cancer not on active treatment.\n4. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; uncomplicated infections are permitted if responding to active treatment.\n5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C.\n6. History of known myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.\n7. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.\n8. Any medical condition that in the judgement of the sponsor is likely to interfere with assessment of safety or efficacy of study treatment.\n9. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n10. Pregnancy (serum pregnancy test must be obtained at time of enrollment for females of childbearing potential and to be repeated 72 hours prior to lymphodepleting chemotherapy regimen); females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be childbearing potential.\n11. Lactating.\n12. In the investigator's judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.\n13. Unwilling to participate in long-term follow-up protocol that is required if CAR T cell therapy is administered at CU Anschutz.\n\nLYMPHODEPLETING CHEMOTHERAPY ELIGIILITY:\n\nIn order to proceed with lymphodepleting chemotherapy, enrolled participants must meet all eligibility criteria below within 72 hours prior to lymphodepletion, unless otherwise specified:\n\n* If the participant received bridging therapy after apheresis, confirmation of disease reevaluation is required. It must be within 6 weeks of initiation of LD chemotherapy.\n\n  * Confirmation that the participant has met the washout period for bridging therapy.\n* Negative serum pregnancy test (for women of childbearing potential)\n* Adequate organ function as defined by:\n\n  * Absolute neutrophil count (ANC) ≥ 500\u002FμL.\n  * Platelet count ≥ 50,000\u002F μL.\n  * Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n  * Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n  * Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C3.0 will be acceptable.\n  * Pulmonary: No clinically significant pleural effusion and; Baseline oxygen saturation must be \\> 92% on room air.\n  * Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO) (only if subject received bridging anthracycline or developed a significant illness prior to LD-chemo per investigator assessment.) If clinically indicated, ECHO must be performed within 2 weeks prior to LD-chemotherapy.\n\nCD19x22 CAR T CELL INFUSION ELIGIBILITY\n\nIn order to proceed with CD19x22 CAR T Cell Infusion, enrolled participants must meet all eligibility criteria below within 24 hours prior to CD19x22 CAR T Cell infusion, unless otherwise specified:\n\n* CD19x22 CAR T cells must have met manufacturing release criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA).\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* ECOG ≤2 or Karnofsky≥ 50%.\n* Clinically stable without evidence of vital sign instability, including the lack of supportive vasoactive drugs or intensive care unit support.\n* Oxygen saturation \\> 92% on room air; cannot be on supplemental oxygen.\n* No evidence of uncontrolled, significant tumor lysis syndrome prior to cell infusion per investigator assessment.\n* No evidence of rapidly progressive NHL per investigator determination.\n* Participants' temperature is \\\u003C38.0 °C within 48 hours prior to cell infusion. (If the source of fever cannot be identified \\[after thorough infectious disease work-up\\], and the suspected cause is underlying malignancy, discussion and approval by the Gates Institute Medical Lead may allow continued infusion of CD19x22 cells. This should be appropriately documented in the patient's medical record.\n* Liver transaminase (ALT and AST) \\\u003C 5 x institutional ULN (\\\u003C grade 3) based on age- and laboratory- specific normal ranges.\n* Adequate renal function as defined by creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by the Cockcroft- Gault equation) ≥ 60 mL\u002Fmin.\n\nIf these criteria are not met, measures can be taken to resolve the underlying condition(s). If successful, cells may be infused up to (and including) 7 days following the time of the planned infusion with no additional lymphodepletion. If the CD19x22 CAR T Cell infusion is delayed more than 7 days, lymphodepleting chemotherapy MAY be repeated, per the investigator's discretion. Prior to commencing a second round of lymphodepletion, participants must meet lymphodepletion criteria described above.","ALL","16 Years",{"count":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed\u002Frefractory (R\u002FR) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.",[26,27,28,29],"Non-Hodgkin Lymphoma","B-cell Non-Hodgkin Lymphoma (B-NHL)","Mantle Cell Lymphoma (MCL)","CNS Lymphoma",[31,32],"Relapsed","Refractory","RECRUITING","2025-12-17",{"date":36,"type":37},"2025-12-24","ACTUAL",{"date":39,"type":37},"2021-12-21",{"date":41,"type":20},"2027-12",{"name":43,"class":44},"University of Colorado, Denver","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100485926","phase-1-study-evaluating-ucart20x22-in-b-cell-non-hodgkin-lymphoma-100485926","NCT05607420","Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma","Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)","NatHaLi-01","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Relapsed or refractory (R\u002FR) mature B-NHL per 2016 WHO criteria and positive for CD20 and\u002For CD22\n* Subjects with NHL subtypes defined by WHO:\n* Dose-Finding Part: R\u002FR mature B-NHL (except chronic lymphocytic leukemia\u002Fsmall lymphocytic leukemia \\[CLL\u002FSLL\\], Richter's transformation from prior CLL\u002FSLL, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia)\n* Dose-Expansion Part: R\u002FR LBCL, defined as:\n\n  i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements; iii. Transformed FL or transformed marginal zone lymphoma (MZL); iv. Follicular lymphoma Grade 3B\n* R\u002FR disease after at least 2 lines of prior treatment, which must have included:\n* An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL\n* An alkylating agent in combination with an anti-CD20 MoAb for FL\n* An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)\n* Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis or manufacture, unable to wait for manufacture, CD19 negative disease, etc.)\n* Autologous hematopoietic stem cells must be available prior to the start of the LD regimen if the subject is considered high-risk for prolonged hematologic toxicity.\n\nExclusion Criteria:\n\n* Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen\n* Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R\u002FR B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen\n* \\> 4 lines of therapy R\u002FR B-NHL prior to start of the LD regimen.\n* Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD\n* Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen\n* Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD\n* Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22\n* Autologous HSCT infusion within 6 weeks of the start of LD\n* Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD\n* Active acute or chronic graft versus host disease (GvHD). Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD\n* Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)\n* Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of R\u002FR B-NHL\n* Presence of an active and clinically relevant CNS disorder\n* Daily treatment with \\>20 mg prednisone or equivalent\n* Known active infection, or reactivation of a latent infection, whether bacterial or viral, fungal, mycobacterial, or other pathogens\n* History of hypersensitivity to alemtuzumab\n* History of neutralizing anti-drug antibody against alemtuzumab\n* Any known uncontrolled cardiovascular disease within 3 months of enrollment\n* Subjects requiring immunosuppressive treatment\n* Major surgery within 28 days prior to start of LD\n* Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ nonmelanoma skin cell cancers and\u002For carcinoma in-situ of the cervix)","18 Years","80 Years",{"count":57,"type":20},80,[23,59],"PHASE2","First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).",[27],[27,63,64,65,66],"Relapsed\u002FRefractory B-NHL","Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy","Allogeneic","Transcription Activator-Like Effector Nuclease (TALEN®)","2025-08-19",{"date":69,"type":37},"2025-08-24",{"date":71,"type":37},"2022-11-01",{"date":73,"type":20},"2027-08",{"name":75,"class":76},"Cellectis S.A.","INDUSTRY",10,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100569417","early-phase-1-an-early-clinical-study-evaluating-the-safety-and-efficacy-of-acnk-sup003-cell-injection-in-the-treatment-of-relapsed-or-refractory-b-cell-non-hodgkins-lymphoma-100569417","NCT06693973","An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Signed an informed consent form in writing and is able to comply with the visits and related procedures specified in the protocol.\n2. Age ≥18 years old, with an expected survival of more than 3 months.\n3. Confirmed by pathology to have CD20+ relapsed or refractory B-cell non-Hodgkin's lymphoma (according to the WHO 2016 lymphoma classification standards), including but not limited to diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and grade 3b follicular lymphoma.\n4. Relapsed or refractory disease, defined by one or more of the following:\n\n   * Relapse, non-response, or progression after hematopoietic stem cell transplantation.\n   * Disease stabilization but with a duration of ≤6 months after at least two cycles of second-line therapy (must have received CD20-targeted drugs \\[excluding CD20-negative tumors\\] and anthracycline drugs).\n   * Disease progression or relapse after second-line therapy (must have received CD20-targeted drugs \\[excluding CD20-negative tumors\\] and anthracycline drugs).\n5. ECOG performance status of 0-2.\n6. Males with fertility potential and women of childbearing age must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last administration of the study drug; women of childbearing age must have a negative pregnancy test at screening.\n7. Lymphoma must have at least one measurable lesion according to the Lugano 2014 criteria, that is, lymph node lesions with a long diameter \\>15 mm or extranodal lesions with a long diameter \\>10 mm, and positive FDG-PET scan (5PS score of 4 or 5); lesions that have previously received radiotherapy are only considered measurable if there is clear evidence of radiographic disease progression after completion of radiotherapy.\n8. Hematological parameters (within 7 days before testing without transfusion or hematopoietic growth factor treatment): Hemoglobin (Hb) ≥80 g\u002FL, Absolute Neutrophil Count (ANC) ≥1×10\\^9\u002FL, Platelet Count (PLT) ≥50×10\\^9\u002FL.\n9. Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (subjects on prophylactic anticoagulant therapy must have an INR between 2.0-3.0).\n10. Hepatic, renal, and pulmonary function must meet the following requirements:\n\n    1. Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL\u002Fmin (estimated by the Cockcroft-Gault formula).\n    2. Total bilirubin ≤1.5×ULN (≤3×ULN for subjects with liver lesions or Gilbert's syndrome).\n    3. ALT and AST ≤3×ULN (≤5×ULN for subjects with liver lesions).\n    4. Under indoor ventilation conditions and without oxygen supplementation, blood oxygen saturation is ≥92%.\n\nExclusion Criteria:\n\n1. Primary central nervous system lymphoma, or active central nervous system involvement or symptoms of central involvement.\n2. Accompanying active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, immune thrombocytopenia, etc.), uncontrolled multi-cavity effusions; presence of grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.\n3. Severe cardiovascular and cerebrovascular history, including but not limited to:\n\n   * Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.\n   * Prolonged QT interval corrected by the Fridericia formula (QTcF), \\>450 ms for males; \\>470 ms for females.\n   * Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurring within 6 months before screening.\n   * Heart failure with a New York Heart Association (NYHA) functional classification of ≥II or left ventricular ejection fraction (LVEF) \\\u003C50%.\n   * Clinically uncontrollable hypertension, with systolic blood pressure still ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg after standardized drug treatment.\n4. Received autologous hematopoietic stem cell transplantation or other autologous cell therapy products within 3 months before lymphodepletion; received allogeneic hematopoietic stem cell transplantation or other allogeneic cell therapy products within 6 months before lymphodepletion; subjects who have undergone other organ transplants.\n5. Received anti-tumor drug treatment or participated in other interventional clinical studies within 4 weeks before lymphodepletion or within 5 half-lives (whichever is shorter), including but not limited to chemotherapy drugs, small molecule targeted drugs, monoclonal antibodies, antibody-drug conjugates, etc.\n6. Received live attenuated vaccine immunization or major surgery within 4 weeks before lymphodepletion, or subjects who require live attenuated vaccine immunization or major surgery during the study period.\n7. Requires long-term (≥3 days) systemic corticosteroid treatment during the study period (dose ≥10 mg\u002Fday prednisone or equivalent corticosteroids), excluding inhaled or topical use; as determined by the investigator.\n8. History of other malignant tumors (except for cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, and ductal carcinoma in situ after radical surgery) in the past or concurrently; suffering from severe diabetes or other severe underlying diseases.\n9. Subjects with fungal, bacterial, viral, tuberculosis, or other infections requiring systemic anti-infective treatment within 14 days before lymphodepletion.\n10. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA copies above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with HCV RNA copies above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis spirochete antibody.\n11. Has life-threatening hypersensitivity reactions or other intolerable conditions to the drugs used in the study, or severe allergic constitution.\n12. Pregnant or breastfeeding women.\n13. The investigator deems that the subject has other conditions that may affect compliance or is not suitable for participating in this study.",{"count":85,"type":20},13,[87],"EARLY_PHASE1","The purpose of this study is to determine whether AcNK-Sup003 cell injection is safe and effective in the treatment of elapsed or refractory B-cell non-Hodgkin's lymphoma.",[27],[91,92,93],"CD19","CD20","NK cells","2024-11-15",{"date":96,"type":37},"2024-11-19",{"date":98,"type":37},"2023-12-27",{"date":100,"type":20},"2026-01-13",{"name":102,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology"]