[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100600098","phase-1-clinical-study-of-u01sscart-19-in-patients-with-b-cell-lymphoma-100600098",false,"NCT07093073","Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma","A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.","Inclusion Criteria:\n\n1. Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.\n2. All of the following conditions must be met:\n\n   1. Age 2-75 years at informed consent; both sexes eligible. For minors (≤18 years), consent must be provided by a parent\u002Flegal guardian; minors able to sign must co-sign with their guardian.\n   2. Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.\n   3. Prior therapy requirements:\n\n      * Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed\u002Frefractory after second-line therapy (one standard chemo-regimen + one salvage regimen).\n\n   Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:\n\n   i. Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:\n\n   • Relapse: progression after prior PR or CR.\n\n   • Refractory: i. PD during\u002Fafter last therapy, or best response ≤SD lasting \\\u003C6 months; OR ii. Relapse or progression after ASCT (biopsy-proven), including relapse\u002FPD ≤12 months post-ASCT or lack of response (SD\u002FPD) to salvage therapy after ASCT.\n3. Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.\n4. ≥1 measurable lesion per Lugano 2014 response criteria.\n5. ECOG performance status 0-3.\n6. Adequate marrow reserve: ALC ≥0.3 × 10⁹\u002FL; PLT ≥30 × 10⁹\u002FL (transfusion permitted).\n7. Adequate organ function:\n\n   • AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related);• Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome);• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault);• Pulmonary: ≤Grade 1 dyspnea and SpO₂ \\>91 % on room air;• LVEF ≥50 % by echocardiography;• INR ≤1.5×ULN and APTT ≤1.5×ULN.\n8. Women of child-bearing potential: negative serum\u002Furine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through ≥12 months after CAR-T infusion.\n9. Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis.\n10. Estimated life expectancy \\>3 months.\n\nExclusion Criteria:\n\n1. Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.\n2. Presence of any of the following:• Positive HBe-Ab and\u002For HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.\n3. Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.\n4. History or current clinically significant CNS disorder unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-that the investigator considers uncontrolled.\n5. Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), NYHA Class III-IV congestive heart failure, myocardial infarction, unstable angina, or other clinically significant cardiac history judged by the investigator; or QTc \\>480 ms (Fridericia correction) or LVEF \\\u003C50 % by echocardiography at screening.\n6. Known primary immunodeficiency.\n7. History of severe immediate hypersensitivity to any study drug.\n8. Receipt of any live vaccine within 6 weeks before screening.\n9. Pregnant or breastfeeding women.\n10. Active autoimmune disease requiring systemic immunosuppressive therapy.\n11. Participation in any other interventional clinical trial within 30 days before signing informed consent.\n12. Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation.","ALL","2 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.",[27],"B Cell Lymphoma",[29,30],"CD19","ssCART-19","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-06","ACTUAL",{"date":37,"type":35},"2025-01-23",{"date":39,"type":21},"2029-01-31",{"name":41,"class":42},"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100595730","phase-1-clinical-study-of-u32-in-patients-with-acute-myeloid-leukemia-100595730","NCT07036250","Clinical Study of U32 in Patients With Acute Myeloid Leukemia","A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and be expected to complete the follow-up examinations and treatments as required by the study protocol.\n2. Be aged ≥2 years and ≤65 years at the time of signing the informed consent form, with no restrictions on gender.\n3. Meet the AML diagnosis according to the 2022 WHO classification and satisfy the diagnostic criteria for relapsed and refractory acute myeloid leukemia as defined in the \"Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)\": a) Relapsed AML diagnostic criteria: reappearance of leukemia cells in peripheral blood after complete remission (CR), or positivity for minimal residual disease (MRD) detected by flow cytometry in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemia cells. b) Refractory AML diagnostic criteria: newly diagnosed cases that are ineffective after two courses of standard treatment; relapse within 12 months after CR and subsequent consolidation therapy; relapse after 12 months that is ineffective to conventional chemotherapy; cases with two or more relapses; persistent extramedullary leukemia.\n4. AML patients who are molecularly positive after treatment and cannot achieve negativity through conventional therapy.\n5. Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry.\n6. Have previously received at least two lines of adequate treatment or allogeneic hematopoietic stem cell transplantation (HSCT).\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3, with an expected survival of more than 3 months.\n8. Have adequate bone marrow reserve at screening, defined as: absolute lymphocyte count (ALC) ≥0.3×10\\^9\u002FL, platelets (PLT) ≥20×10\\^9\u002FL (including with platelet transfusion support).\n9. Have appropriate organ function: aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL\u002Fmin; hemoglobin ≥60 g\u002FL or maintained at this level after transfusion; peripheral capillary oxygen saturation ≥92%; left ventricular ejection fraction (LVEF) ≥45%.\n10. Female subjects must meet the following criteria to be considered for enrollment: a) Be of non-childbearing potential, defined as: having undergone hysterectomy or bilateral oophorectomy, or having had bilateral tubal ligation, or being postmenopausal (complete cessation of menstruation for ≥1 year); b) Be of childbearing potential, but have a negative serum pregnancy test at screening, and agree to use medically accepted contraceptive measures (such as intrauterine device, oral contraceptives, or condoms) before enrollment and during the study, until 1 year after the last study drug administration.\n11. Male subjects of childbearing potential must agree to use barrier contraception or complete abstinence until 1 year after the last study drug administration.\n12. Have sufficient venous access for apheresis or intravenous blood draw, and no contraindications for leukapheresis.\n13. For subjects who have received daratumumab or other CD38 - targeted therapies, the washout period for CD38 monoclonal antibody should be at least 3 months before the reinfusion treatment.\n\nExclusion Criteria:\n\n1. Having other malignancies within 3 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.\n2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with detectable HBV-DNA levels above the lower limit of detection in peripheral blood; positive for hepatitis C virus (HCV) antibodies with detectable HCV-RNA levels above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibodies; positive for cytomegalovirus (CMV) DNA; positive for EBV-DNA; positive for syphilis serology.\n3. A history of severe allergic reactions \\[defined as allergic reactions of grade 2 or higher, with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchial spasm, cyanosis, shock, respiratory or cardiac arrest\\] or known allergy to any active ingredient, excipient, or murine product or xenoprotein contained in the study drug (including the lymphodepletion regimen).\n4. Severe cardiac disease, including but not limited to severe arrhythmias, unstable angina, large myocardial infarction, New York Heart Association (NYHA) Class III or IV heart failure, refractory hypertension (defined as failure to achieve target blood pressure despite the use of a reasonable and tolerable regimen of ≥3 antihypertensive medications \\[including diuretics\\] for \\>1 month or requiring ≥4 antihypertensive medications for effective blood pressure control).\n5. History of solid organ transplant or planned solid organ transplant (excluding allogeneic hematopoietic stem cell transplant).\n6. Acute or chronic graft-versus-host disease (GVHD) that is deemed uncontrollable by the investigator.\n7. Allogeneic hematopoietic stem cell transplant within 6 months prior to screening.\n8. Active autoimmune or inflammatory disease (e.g., Guillain-Barré syndrome \\[GBS\\], amyotrophic lateral sclerosis \\[ALS\\]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]).\n9. Presence of a tumor emergency (e.g., spinal cord compression, bowel obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment prior to screening or infusion.\n10. Presence of uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic therapy.\n11. Planned to undergo major surgery within 4 weeks prior to lymphodepletion or during the study period, or surgical wounds not fully healed prior to enrollment.\n12. Presence of severe psychiatric disorders.\n13. Within 1 week prior to planned PBMC collection, receiving systemic corticosteroids or immunosuppressive agents that are deemed by the investigator to affect cell preparation. a) Systemic corticosteroids: subjects receiving systemic corticosteroid therapy within 1 week prior to planned PBMC collection and deemed by the investigator to require long-term systemic corticosteroid therapy during the treatment period (excluding inhaled or topical use); b) Immunosuppressive agents: subjects receiving immunosuppressive agents within 1 week prior to planned PBMC collection.\n14. Received live-attenuated or live virus vaccines within 4 weeks prior to screening.\n15. History of alcoholism or drug abuse.\n16. Participation in another interventional clinical trial within 30 days prior to screening.\n17. Any subject deemed by the investigator, based on clinical judgment or standards of care, to have a contraindication to any study procedure or other medical conditions that may pose an unacceptable risk.","65 Years",{"count":53,"type":21},20,[24,55],"PHASE2","This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.",[58],"Acute Myeloid Leukaemia",[60,61,62],"CAR-T","CD38","CLL-1","2025-06-23",{"date":65,"type":35},"2025-06-25",{"date":67,"type":21},"2025-07-03",{"date":69,"type":21},"2029-12-31",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100563324","phase-1-u87-car-t-in-patients-with-advanced-head-and-neck-tumors-100563324","NCT06614686","U87 CAR-T in Patients With Advanced Head and Neck Tumors","A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors","Inclusion Criteria:\n\n1. Subjects have provided informed consent, understanding the study\\'s risks and benefits, and are willing to complete the study procedures.\n2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.\n3. ECOG performance status of 0-1.\n4. Anticipated survival of at least 12 weeks.\n5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available\n6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.\n7. At least one measurable tumor lesion according to RECIST 1.1.\n8. Suitable venous access for mononuclear cell collection.\n9. Adequate major organ function.\n10. Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.\n2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.\n3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.\n4. Previous Trop2-targeted CAR-T\u002FTCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.\n5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.\n6. Active infection requiring intravenous anti-infective therapy.\n7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.\n8. Primary immunodeficiency or active autoimmune disease.\n9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.\n10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.\n11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.\n12. Allergy to protein drugs or multiple medications.\n13. Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell\u002Forgan transplantation. Uncontrollable third-space fluid accumulation.\n14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.\n\n    Pregnant or breastfeeding women.\n15. Uncontrollable psychiatric history.\n16. Other conditions deemed unsuitable for study participation by the investigator.","18 Years","70 Years",{"count":53,"type":21},[24],"This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.",[84,85],"Nasopharynx Cancer","Head and Neck Cancer",[87,88],"Chimeric Antigen Receptor T Cell","U87","2024-09-25",{"date":91,"type":35},"2024-09-26",{"date":93,"type":21},"2024-09-20",{"date":95,"type":21},"2027-12-31",{"name":41,"class":42},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100498305","phase-1-clinical-study-of-u16-in-patients-with-relapsed-or-refractory-non-hodgkins-lymphoma-100498305","NCT05768529","Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma","A Single-arm, Open and Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory\u002FRecurrent B-cell Non-Hodgkin's Lymphoma (r\u002Fr B-NHL)","Inclusion Criteria:\n\n1. Patients who are willing to sign the informed consent form and have good compliance;\n2. Aged 18-70 years, male or female;\n3. CD20-positive B-cell non-Hodgkin's lymphoma with immunohistochemistry(IHC), with the following diagnostic: Diffuse large B cell lymphoma (DLBCL), or Primary mediastinal large B cell lymphoma (PMBCL), or Follicular lymphoma transformed large B cell lymphoma (TFL) , or High grade B cell lymphoma(HGBCL);\n4. Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including: a) Received anthracycline-containing drugs and rituximab or other CD20-targeted drugs (except CD20-negative tumors); b) Definition of line: Stable disease (SD) after receiving a first-line therapy for at least 4 cycles or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD; c) For transformed follicular lymphoma (TFL), patients must be treated adequately against FL, and after transformation, must have received at least once the therapy against TFL, and become relapsed or refractory after the last therapy;\n5. In relapsed or refractory status at screening: a) Definition of relapse: Remission (including partial remission (PR) or complete remission (CR)) after treatment with at least the standard therapy regimen, and then PD; b)Definition of refractory: i. Non-response to the last therapy: The best response by the last therapy is SD or PD, and the duration is less than 6 months; ii. Relapse or progression (it must be proved by biopsy) after ASCT, including: Relapse or PD within 12 months after ASCT; if a salvage therapy is received, the patient is non-response (SD or PD) to the last therapy;\n6. According to Lugano Criteria (Cheson2014), at least one measurable lesion exists；\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n8. Adequate bone marrow reserve, defined as: Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL; Absolute lymphocyte count (ALC) ≥ 0.3×10\\^9\u002FL; Platelet (PLT) ≥50×10\\^9\u002FL;\n9. Proper organ function, defined as: Aspartate aminotransferase (AST) ≤ 3 Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) ≤ 3 ULN(AST and ALT≤5 ULN are required for the patients with hepatic dysfunction due to tumor cell infiltration) ; Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation \\> 91% at non-oxygen inhalation status;\n10. Women with child-bearing potential are negative in blood\u002Furine pregnancy tests within 7 d prior to infusion of U16 infusion; any male or female patient with child-bearing potential must agree to adopt effective contraceptive measures throughout the study, and at least one year after administration of the investigational therapy.\n11. Qualified T cell function;\n12. Vascular conditions for apheresis, and no other contraindications for apheresis;\n13. Elution period of CD20 monoclonal antibody at least 3 months before U16 infusion;\n14. Life expectancy more than 3 months.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors, except for disease-free survival for more than 3 years or carcinoma in-situ;\n2. Patients with lymphoma involved with atrium or ventricle；\n3. Used immunosuppressants, hormones or high-dose chemotherapy within 2 weeks before signing the informed consent form, or planned to use immunosuppressants or hormones(specifically referring to systemic therapy) before apheresis, except for local or inhaled corticosteroid therapy;\n4. Patients complying with any of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive; hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection; hepatitis C antibody (HCV-Ab) positive and HBV-RNA copies being more than the lower limit of detection; anti-treponemia pallidum antibody (TP-Ab) positive; Human immunodeficiency virus (HIV) antibody positive; EBV-DNA, and CMV-DNA copies being more than the lower limit of detection;\n5. Patients with bacteria, fungi, viruses, mycoplasma or other types of infections, and difficult for controlling by researcher's judgment;\n6. Patients with active primary or secondary central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture to exclude CNS lymphoma)；\n7. Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia\u002Fhemorrhage, dementia, cerebellum disease, or any autoimmune disease involved with central nervous system；\n8. Patients with cardiac angioplasty or stent implantation within 12 months before signing the informed consent form, or myocardial infarction, unstable angina pectoris, other clinically significant heart disease history judged by researcher;\n9. Patients need urgent clinical emergencies (such as intestinal obstruction or vascular compression, etc.) due to the obstruction or compression of lymphoma judged by researcher;\n10. Patients previously received CAR-T cell therapy with CD20 target;\n11. Patients with primary immunodeficiency;\n12. Patients who are known with a history of hypersensitivity reaction to any ingredient used for the drug product in the trial.;\n13. Patients vaccinated with a live vaccine within 6 weeks prior to screening;\n14. Pregnant or lactating women;\n15. Patients with active autoimmune diseases;\n16. Patients with active acute or chronic graft-versus-host disease (GVHD) when signing the informed consent form;\n17. Received allogeneic hematopoietic stem cell transplantation within 6 months before signing the informed consent form;\n18. Participated in any other clinical trial within 30 days before signing the i informed consent form;\n19. Patients with other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.",{"count":105,"type":21},100,[24,55],"The study is a Phase I\u002FII, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.",[109],"Relapsed or Refractory Non-Hodgkin's Lymphoma","2023-09-17",{"date":112,"type":35},"2023-09-21",{"date":114,"type":35},"2023-03-28",{"date":116,"type":21},"2026-12-31",{"name":41,"class":42},2,""]