[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"YANRU WANG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,69,93],{"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},"100617307","phase-1-a-clinical-study-of-of-rn1701-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphomas-100617307",false,"NCT07316920","A Clinical Study of of RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","Inclusion Criteria:\n\n1. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.\n2. Age 18-75 years; either sex.\n3. ECOG performance status 0-1.\n4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and\u002For CD20 positive.\n5. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \\>1.5 cm, extranodal lesion \\>1.0 cm.\n6. Prior treatment response must meet one of the following:\n\n   • Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse\u002Fprogression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory\u002Frelapse criteria.\n\n   • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   • Mantle-cell lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n7. Estimated life expectancy ≥3 months.\n8. Screening laboratory values (may be repeated once):\n\n   * Hemoglobin ≥8.0 g\u002FdL (no transfusion within 7 days).\n   * Platelets ≥50×10⁹\u002FL (no transfusion within 7 days).\n   * ANC ≥1.0×10⁹\u002FL (growth-factor support allowed if none within 7 days of test).\n   * AST\u002FALT ≤3×ULN (≤5×ULN if liver involvement).\n   * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault).\n   * Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN).\n   * INR, PT, APTT \\\u003C1.5×ULN.\n9. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.\n10. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide\u002Ffludarabine.\n11. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions are ineligible for this trial:\n\n  1. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except:\n\n     * Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or\n     * Adequately treated non-melanoma skin cancer with no current evidence of disease.\n  2. Prior anti-cancer therapy within the stated windows (before lymphodepletion):\n\n     * CNS prophylaxis (e.g., intrathecal methotrexate and\u002For cytarabine) within 7 days;\n     * Cytotoxic chemotherapy or radiotherapy within 14 days;\n     * Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer;\n     * Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter;\n     * Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies);\n     * Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.\n  3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.\n  4. Any allogeneic cellular (including CAR-T) or gene therapy.\n  5. Prior allogeneic haematopoietic stem-cell transplantation.\n  6. Positive donor-specific antibody (DSA).\n  7. At least one of the following high-risk features:\n\n     * Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²;\n     * Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \\>1\u002F3 of thoracic diameter;\n     * Obstructive\u002Fcompressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.\n  8. Active CNS involvement (symptomatic or positive CSF\u002Fimaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.\n  9. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam\u002FUS, cytopenias, hyperplastic marrow) or ongoing anticoagulation.\n  10. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).\n  11. Severe underlying medical conditions:\n\n      * Active serious viral, bacterial or uncontrolled systemic fungal infection;\n      * Active systemic autoimmune disease requiring therapy.\n  12. Significant cardiac disease:\n\n      * NYHA class III or IV congestive heart failure;\n      * Myocardial infarction or CABG within 6 months before enrolment;\n      * Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related;\n      * Severe non-ischaemic cardiomyopathy;\n      * Left ventricular ejection fraction (LVEF) \\\u003C45% by echo or MUGA within 4 weeks before lymphodepletion.\n  13. Resting oxygen saturation \\\u003C92%.\n  14. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.\n  15. Live-attenuated vaccine within 4 weeks before screening.\n  16. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).\n  17. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.\n  18. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.\n  19. Lactating women.\n  20. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.","ALL","18 Years","75 Years",{"count":20,"type":21},19,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19\u002FCD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and\u002For CD20-positive cells in patients with relapsed\u002Frefractory B-cell lymphoma.",[27],"Relapsed\u002FRefractory B-cell Lymphoma",[29,30],"Relapsed\u002Frefractory","B-cell lymphoma","NOT_YET_RECRUITING","2026-01-02",{"date":34,"type":35},"2026-01-06","ACTUAL",{"date":37,"type":21},"2025-12-22",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"YANRU WANG","OTHER",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":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":43},"100617306","phase-1-a-clinical-study-of-allogenic-cd19-car-t-in-the-treatment-of-rr-b-cell-hematologic-malignancies-100617306","NCT07316907","A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R\u002FR B-Cell Hematologic Malignancies","An Exploratory Clinical Study of the Safety and Efficacy of Allogenic CD19-Targeted Chimeric Antigen Receptor T-Cell Injection in the Treatment of Relapsed\u002FRefractory B-Cell Hematologic Malignancies","Inclusion Criteria:\n\n1. Voluntary participation in this trial with signed informed consent.\n2. Diagnosis of B-cell hematologic malignancy according to the 2017 WHO classification, including B-acute lymphoblastic leukemia (B-ALL) and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia (SLL\u002FCLL), mantle-cell lymphoma (MCL), etc.\n3. Refractory or relapsed B-cell malignancy defined as failure to achieve complete remission after standard therapy, or relapse after achieving remission with first-line or salvage therapy.\n4. Persistence of minimal residual disease (MRD) positivity despite hematologic remission in B-cell acute lymphoblastic leukemia (ALL).\n5. At least one measurable lesion ≥1.5 cm in longest diameter by IWG revised criteria for relapsed\u002Frefractory lymphoma.\n6. Age 18-70 years; both sexes eligible.\n7. Expected survival ≥12 weeks.\n8. Adequate organ function as follows (no blood products or growth factors within 14 days before first infusion):\n\n1). Hematology: A. White blood cell count (WBC) ≥3.0×10⁹\u002FL B. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL C. Platelet count (PLT) ≥100×10⁹\u002FL D. Hemoglobin (Hb) ≥90 g\u002FL 2). Renal: A. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL\u002Fmin 3). Cardiac: A. Left ventricular ejection fraction (LVEF) ≥50 % B. QTc (Fridericia) ≤450 ms (men) or ≤470 ms (women) 4). Hepatic: A. Total bilirubin ≤1.5×ULN B. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement) 5). Coagulation: A. International normalized ratio (INR) or Prothrombin time (PT) ≤1.5×ULN B. Activated partial thromboplastin time (APTT) ≤1.5×ULN 6). Pulmonary: Diffusing capacity of the lung (DLCO) ≥50 % of predicted (with or without correction for anemia\u002Falveolar volume).\n\n9\\. ECOG performance status 0-2 at screening. 10. LVEF ≥50 % and no pericardial effusion. 11. At least 2 weeks since last prior therapy (radiation, chemotherapy, monoclonal antibody, or other systemic treatment).\n\n12\\. Recovery to ≤CTCAE Grade 1 for any preceding serious adverse event (SAE). 13. WOCBP\\* not surgically sterilized must use highly effective contraception from study start through 6 months after last dose; men with WOCBP partners must use highly effective contraception through 3 months after last dose. WOCBP must have negative serum β-hCG within 7 days before first dose and must not be breastfeeding.\n\n14\\. Ability to comply with study visit schedule and all protocol requirements.\n\n\\*WOCBP = women of child-bearing potential\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions are ineligible for this trial:\n\n  1. Known hypersensitivity, allergic reaction, intolerance, or contraindication to 19UCART or any study-drug component (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe anaphylaxis.\n  2. Post-allo-HSCT relapse with active graft-versus-host disease requiring systemic corticosteroids or other immunosuppressants.\n  3. Uncontrolled active infection of any etiology.\n  4. Active hepatitis B, hepatitis C, or tuberculosis.\n  5. HIV or syphilis infection.\n  6. Active autoimmune disease or history of severe autoimmune disorder (as judged by the PI) requiring prolonged immunosuppressive therapy.\n  7. Congenital or acquired immunodeficiency syndromes.\n  8. New York Heart Association (NYHA) class III or IV heart failure, unstable angina, myocardial infarction within 6 months, or sustained (\\>30 s) ventricular arrhythmia.\n  9. History of epilepsy or other significant central nervous system disorders.\n  10. Extra-nodal lymphomatous involvement of brain, lung, or gastrointestinal tract.\n  11. Prior malignancy other than:\n\n      1. Curatively resected non-melanoma skin cancer (e.g., basal-cell carcinoma)\n      2. Curatively treated carcinoma in situ (cervical, bladder, breast, etc.)\n  12. Systemic high-dose corticosteroids within 2 weeks before study entry.\n  13. Pregnancy, lactation, or intention to become pregnant within 6 months.\n  14. Participation in another clinical trial within 1 month.\n  15. Anticipated need for any other systemic anti-neoplastic therapy during the study.\n  16. Major surgery within 14 days before first study-drug administration.\n  17. Any condition that, in the investigator's opinion, could increase patient risk or interfere with study results.","70 Years",{"count":53,"type":21},12,[24],"This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed\u002Frefractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed\u002Frefractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed\u002Frefractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed\u002Frefractory B-cell hematologic malignancies.",[57,58],"Hematologic Malignancies","Lymphoma",[60,61,62],"CD19-positive","relapsed\u002Frefractory","B-cell hematologic malignancies","2025-12-19",{"date":65,"type":35},"2026-01-05",{"date":37,"type":21},{"date":39,"type":21},{"name":41,"class":42},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":43},"100591131","early-phase-1-a-clinical-study-of-allogeneic-cd19bcma-car-t-cells-for-the-treatment-of-rr-b-cell-malignant-tumors-100591131","NCT06976437","A Clinical Study of Allogeneic CD19\u002FBCMA CAR-T Cells for the Treatment of R\u002FR B-cell Malignant Tumors","An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CD19\u002FBCMA CAR-T Cell Treatment for Relapsed\u002F Refractory B-cell or Plasma Cell-derived Malignant Tumors","Inclusion Criteria:\n\n1. Willingness to participate in the trial and provision of signed informed consent.\n2. Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia (SLL\u002FCLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.\n3. Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.\n4. Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).\n5. According to the revised International Working Group (IWG) criteria, relapsed\u002Frefractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.\n6. 18 Years and older, regardless of gender.\n7. An expected survival of ≥12 weeks.\n8. Serum total bilirubin level \\\u003C twice the upper limit of normal, serum creatinine level \\\u003C upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C three times the upper limit of normal.\n9. Absolute neutrophil count ≥0.5×10⁹\u002FL, platelets ≥20×10⁹\u002FL; for B-lymphocyte malignancies with definitive bone marrow involvement, no requirements for neutrophil and platelet counts.\n10. ECOG performance status of 0 - 2.\n11. Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.\n12. At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, intolerance, or contraindications to CD19\u002FBCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.\n2. Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.\n3. Severe active infection.\n4. Acquired or congenital immunodeficiency.\n5. New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.\n6. History of epilepsy or other central nervous system diseases.\n7. Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.\n8. Other primary cancers, except:\n\n   1. Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.\n   2. Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.\n9. Systemic high-dose steroids within 2 weeks before treatment.\n10. Pregnant, breastfeeding, or plans to become pregnant within 6 months.\n11. Participation in another clinical trial within the past month.\n12. Any situation the investigator deems may raise risks or interfere with trial results.",{"count":77,"type":21},21,[79],"EARLY_PHASE1","A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed\u002Frefractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed\u002Frefractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed\u002Frefractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed\u002Frefractory B-cell or plasma cell-derived malignant tumors.",[82,83],"B Cell Lymphoma","Multiple Myeloma","RECRUITING","2025-07-05",{"date":87,"type":35},"2025-07-10",{"date":89,"type":35},"2025-05-06",{"date":91,"type":21},"2027-12-30",{"name":41,"class":42},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100540568","early-phase-1-a-clinical-study-of-cd19-car-nk-cells-for-the-treatment-of-relapsedrefractory-b-cell-related-autoimmune-diseases-100540568","NCT06318533","A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed\u002FRefractory B-cell Related Autoimmune Diseases","An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Relapsed\u002FRefractory B-cell Related Autoimmune Diseases","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures\n2. Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases\n3. Age: ≥ 18 years old and ≤ 70 years old, male or female\n4. Subjects with estimated survival \\> 12 weeks\n5. Adequate organs function: Serum creatinine clearance meets relevant age\u002Fsex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)\n6. ECOG performance ≤ 2\n7. Left ventricular ejection fraction (LVEF) ≥ 45%\n8. Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions\n2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes\n3. Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections\n4. Subjects with grade III or IV heart failure (NYHA classification)\n5. History of epilepsy or other central nervous system (CNS) diseases\n6. History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors\n7. Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism\n8. Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment\n9. Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months\n10. Females who are pregnant, lactating, or planning a pregnancy within six months\n11. Subjects who have received other clinical trial treatment within 3 months\n12. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":101,"type":21},15,[79],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed\u002Frefractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\\^9 cells, 9×10\\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed\u002Frefractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed\u002Frefractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed\u002Frefractory B-cell related autoimmune diseases.",[105],"Autoimmune Diseases","2025-05-07",{"date":108,"type":35},"2025-05-11",{"date":110,"type":35},"2024-03-13",{"date":112,"type":21},"2027-03-13",{"name":41,"class":42},2,""]