[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Starna Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,61,85],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100642246","early-clinical-study-on-the-safety-tolerability-pharmacokinetics-and-efficacy-of-str-p005-100642246",false,"NCT07655453","Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005","Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005 in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form.\n2. Aged 18 to 75 years (inclusive).\n3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.\n4. Adequate organ function:\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥1.0×10\\^9\\^\u002FL, Absolute Lymphocyte Count (ALC) ≥0.1×10\\^9\\^\u002FL, Hemoglobin ≥80 g\u002FL, Platelet count (PLT) ≥50×10\\^9\\^\u002FL. Blood transfusion and growth factors cannot be used within 7 days prior to eligibility screening to meet these requirements.\n   2. Coagulation: International Normalized Ratio (INR) ≤1.5 × Upper Limit of Normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.\n   3. Liver function: Serum AST, ALT ≤3.0 × ULN, Total Bilirubin ≤1.5 × ULN (for subjects with Gilbert's syndrome, Total Bilirubin \\\u003C3.0 × ULN).\n   4. Renal function: Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula); if with renal involvement, CrCl ≥45 mL\u002Fmin.\n   5. Cardiac function: New York Heart Association (NYHA) Class I or II, and Left Ventricular Ejection Fraction (LVEF) ≥50% by Echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or Ischemic Heart Disease (IHD) within 8 weeks prior to screening.\n   6. Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.\n\n      \\-\n\nExclusion Criteria:\n\n1. Patients who have received any cell immunotherapy in the past, except where there is evidence that the engineered immune cells have disappeared and peripheral blood B cells are still present.\n2. Unable to meet the following washout periods for therapeutic drugs:\n\n   1. Use of therapeutic doses of corticosteroids (Prednisone ≥20mg\u002Fday or equivalent dose of other corticosteroids) within 72 hours prior to first dose, but topical or inhaled steroids are allowed.\n   2. Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks prior to screening.\n   3. Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks prior to screening.\n   4. Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month prior to screening; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52 mAb, anti-CD38 mAb, ATG within at least 3 months.\n   5. Other monoclonal antibodies, bispecific antibodies, trispecific antibodies, antibody-drug conjugates (ADC), or any B-cell depleting drugs require a washout of 3 months or 5 half-lives (whichever is shorter) prior to screening.\n   6. Undergone plasmapheresis, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 2 weeks prior to screening.\n3. History of ≥ Grade 2 bleeding within 30 days prior to screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, or Factor Xa inhibitors), except if INR ≤ 1.5 × ULN.\n4. Severe renal disease: Severe lupus nephritis within 8 weeks prior to screening \\[defined as urine protein \\> 6g\u002F24 hours or serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL or creatinine clearance (Cockcroft-Gault formula) \\\u003C 30 mL\u002Fmin\\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \\>100mg\u002Fday or equivalent corticosteroid for ≥14 days.\n5. Severe pulmonary disease within 3 months prior to screening, such as moderate-to-severe pulmonary hypertension (mean pulmonary artery pressure \\> 60 mmHg by echocardiography), requiring oxygen therapy via reservoir mask or non-invasive\u002Finvasive mechanical ventilation at screening.\n6. Occurrence of lupus crisis within 3 months prior to screening, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.\n7. History or related symptoms of active non-lupus-induced central nervous system disease (excluding isolated trigeminal nerve disease) within 6 months prior to screening, including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, and symptoms such as epilepsy, convulsions, aphasia, dementia, etc.\n8. Occurrence of any of the following cardiovascular diseases within 6 months prior to screening (including but not limited to):\n\n   1. Congestive heart failure, myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary\u002Fperipheral artery bypass surgery.\n   2. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes); congenital long QT syndrome, left anterior hemiblock (bifascicular block), complete left bundle branch block or high-grade AV block; history of severe non-ischemic cardiomyopathy; asymptomatic right bundle branch block is allowed for study entry.\n   3. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.\n   4. Current active cardiac involvement, such as pericarditis, pericardial effusion, and myocarditis.\n9. Active tuberculosis or latent tuberculosis at screening (defined as positive tuberculin skin test or interferon-gamma release assay without clinical symptoms or radiographic evidence).\n10. Screening results showing HBV-DNA, HCV-RNA, CMV-DNA above the laboratory's detection limit, or HIV antibody positive.\n11. Presence of uncontrolled fungal, bacterial, viral or other infections deemed unsuitable for study participation by the investigator.\n12. Presence of uncontrolled diabetes mellitus (HbA1c ≥ 7.0%); and uncontrolled thyroid disease (TSH \\> 10 mIU\u002FL or \\\u003C 0.1 mIU\u002FL, and FT4 outside normal range).\n13. History of major organ transplant (e.g., heart, lung, kidney, liver) or history of allogeneic hematopoietic stem cell transplant within 12 weeks or autologous hematopoietic stem cell transplant within 6 weeks prior to screening.\n14. Congenital immunoglobulin deficiency.\n15. Thrombotic Thrombocytopenic Purpura (TTP)\u002FThrombotic Microangiopathy (TMA).\n16. Concomitant history of other autoimmune diseases (including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu's arteritis) requiring systemic treatment, besides the target indications.\n17. Family history of non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy.\n18. History or concurrent presence of other active malignancies, including patients with malignancy-associated polymyositis\u002Fdermatomyositis. Exceptions: carcinoma in situ of the cervix, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, ductal carcinoma in situ of the breast post-resection, and papillary thyroid cancer that have been cured and without recurrence for at least 2 years.\n19. History of hypersensitivity or life-threatening reaction to the study drug or any of its components or formulation ingredients.\n20. Pregnant or breastfeeding women.\n21. Received any live attenuated vaccine within 6 weeks prior to first dose, or planned to receive one within 3 months after treatment.\n22. Participation in another interventional clinical study and received an active investigational drug within 3 months prior to signing ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.\n23. Patients with mental illness such as depression or suicidal tendencies.\n24. Other factors considered by the investigator to make the subject unsuitable for enrollment or affect the subject's participation or completion of the study.\n\n    \\-","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed\u002Frefractory autoimmune diseases.\n\nThe study will employ the traditional \"3+3\" dose escalation model, setting up 3 dose groups: Amg\u002Fkg, Bmg\u002Fkg, C mg\u002Fkg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK\u002FPD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK\u002FPD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.",[27],"Relapsed\u002FRefractory Autoimmune Diseases","NOT_YET_RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":21},"2026-08-01",{"date":36,"type":21},"2028-07-30",{"name":38,"class":39},"Starna Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100620925","to-evaluate-the-safety-and-tolerability-of-str-p004-for-the-treatment-of-immune-mediated-kidney-diseases-100620925","NCT07363954","To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases","A Clinical Study on the Safety, Efficacy, and Pharmacokinetics of STR-P004 for the Treatment of Immune-Mediated Kidney Diseases","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent. 2. Age between 18 and 75 years (inclusive). 3. Confirmed CD19-positive B cell expression in peripheral blood by flow cytometry.\n\n  4.Adequate organ function:\n  1. Bone marrow function: defined as absolute neutrophil count (ANC) ≥1500 \u002FμL, absolute lymphocyte count (ALC) ≥100 \u002FμL, hemoglobin (Hb) ≥80 g\u002FL, platelet count (PLT) ≥50,000 \u002FμL. Use of transfusions or growth factors to meet these requirements within 7 days prior to screening is not allowed.\n  2. Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN, total bilirubin \\\u003C1.5×ULN (\\\u003C3.0×ULN for subjects with Gilbert's syndrome).\n  3. Coagulation function: defined as International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.\n  4. Pulmonary function: defined as ≤ CTCAE Grade 1 dyspnea and oxygen saturation (SpO2) ≥92% on room air at rest (by pulse oximetry).\n\n     5\\. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective contraceptive methods from signing ICF until 1 year after STR-P004 infusion (including during study treatment interruption). Male subjects with partners of childbearing potential must agree to use effective barrier contraception methods for 1 year after STR-P004 infusion and should not donate semen or sperm during the entire study period.\n\n     6\\. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and within 48 hours prior to STR-P004 infusion. Women who have undergone sterilization or are postmenopausal for at least 2 years are considered not of childbearing potential.\n\n     Exclusion Criteria:\n* 1\\. Any clinically significant underlying disease, other than SLE\u002FLN, AAV\u002FAAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, that, in the investigator's opinion, poses a safety risk or problem.\n\n  2\\. Rapidly progressive glomerulonephritis not related to SLE\u002FLN, AAV\u002FAAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, defined as ≥50% reduction in eGFR within 3 months since diagnosis.\n\n  3\\. Other uncontrolled serious conditions not directly related to the disease prior to screening, such as severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.",{"count":48,"type":21},9,[24],"This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg\u002Fkg, DL2 XXmg\u002Fkg, DL3 XXmg\u002Fkg. Starting dose is XX mg\u002Fkg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK\u002FPD parameters obtained.",[52],"Autoimmune Diseases","2026-01-15",{"date":55,"type":32},"2026-01-23",{"date":57,"type":21},"2026-02-02",{"date":59,"type":21},"2028-02-01",{"name":38,"class":39},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100611797","to-evaluate-the-safety-tolerability-and-preliminary-antitumor-activity-of-str-p004-100611797","NCT07245251","To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004","An Early-Phase Clinical Study Evaluating the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed\u002FRefractory CD19-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\nSubjects with relapsed\u002Frefractory CD19-positive B-cell acute lymphoblastic leukemia who currently have poor prognosis treatment options:\n\n1. Patients voluntarily sign the informed consent form;\n2. Age between 18 and 65 years, regardless of gender;\n3. Diagnosed with B-cell acute lymphoblastic leukemia and meeting any of the following conditions:\n\n   * (1) Relapse: Relapse within 12 months after first remission following standard treatment;\n   * (2) Refractory:\n\n     1. No remission after ≥6 weeks of induction therapy or two courses of induction therapy;\n     2. Relapse after ≥2 complete remissions (CR) or CR with incomplete hematologic recovery (CRi);\n     3. First relapse after chemotherapy, with no remission after at least one salvage therapy;\n   * d) Relapse after autologous or allogeneic hematopoietic stem cell transplantation;\n4. Within 3 months before screening, bone marrow or peripheral blood tests show leukemia cells expressing CD19;\n5. For Ph+ ALL patients, treatment failure with at least two tyrosine kinase inhibitors (TKIs) (including at least one second-generation TKI) or intolerance to TKI therapy; if the patient has a T315I mutation, TKI salvage therapy is not required;\n6. During screening, the proportion of bone marrow blasts and immature lymphocytes is ≥5%;\n7. Hemoglobin ≥60 g\u002FL, platelets ≥30 × 10\\^9\u002FL;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n9. Adequate organ function, meeting the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤3 × ULN;\n   * Total serum bilirubin ≤2 × ULN, unless combined with Gilbert's syndrome; patients with Gilbert's syndrome may be included if total serum bilirubin ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN;\n   * Serum creatinine ≤2.0 × ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft and Gault formula);\n   * Minimum lung reserve: defined as ≤ grade 1 dyspnea and oxygen saturation \\>91% without oxygen supplementation;\n   * International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n10. Women of childbearing potential must have a negative blood\u002Furine pregnancy test during screening and within 3 days before dosing. Any patient with reproductive potential must agree to use effective contraception throughout the study and for at least 2 years after the last dose of study treatment. As judged by the investigator, patients are considered to have reproductive potential if they are biologically capable of having children and have normal sexual activity. Female patients without reproductive potential (i.e., meeting at least one of the following criteria): hysterectomy, bilateral oophorectomy, bilateral tubal ligation, medically confirmed ovarian failure, or medically confirmed menopause (≥12 consecutive months of amenorrhea).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria cannot be enrolled:\n\n1. Active central nervous system (CNS) leukemia (patients with CNS disease symptoms must undergo lumbar puncture to exclude CNS leukemia);\n2. Isolated extramedullary relapse;\n3. Prior CAR-T therapy or other genetically modified cell therapy within 6 months before screening;\n4. Chemotherapy within 2 weeks before dosing, except for the following:\n\n1\\.\n\n* Pre-treatment chemotherapy as specified in the protocol;\n* TKI and hydroxyurea must be discontinued 72 hours before cell infusion;\n* 6-mercaptopurine, 6-thioguanine, methotrexate (standard dose), cytarabine (standard dose), vincristine, and asparaginase must be discontinued 1 week before cell infusion;\n* Intrathecal chemotherapy for CNS leukemia prophylaxis must be discontinued 1 week before cell infusion; 2. Systemic corticosteroid therapy discontinued for less than 72 hours before dosing, except for physiological replacement doses (e.g., prednisone \\\u003C10 mg\u002Fday or equivalent); 3. Acute graft-versus-host disease (GVHD) within 4 weeks before screening or moderate to severe chronic GVHD; systemic medication for GVHD within 4 weeks before dosing; 4. Active systemic autoimmune disease under treatment; 5. Any of the following:\n* Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive;\n* Hepatitis B e antibody (HBe-Ab) positive with HBV-DNA copy number above the lower limit of quantification;\n* Hepatitis C antibody (HCV-Ab) positive;\n* Anti-Treponema pallidum antibody (TP-Ab) positive;\n* Human immunodeficiency virus (HIV) antibody positive;\n* EBV-DNA or CMV-DNA copy number above the lower limit of quantification; 6. History or presence of other malignancies within 5 years before screening, except for those with low risk of recurrence as judged by the investigator after curative treatment and follow-up for more than 5 years; 7. Any of the following cardiac conditions:\n* Left ventricular ejection fraction (LVEF) ≤45% (ECHO);\n* New York Heart Association (NYHA) class III or IV congestive heart failure;\n* Severe arrhythmia requiring treatment or clinically significant conduction abnormalities on ECG, including QTc interval ≥480 ms (QTcB = QT\u002FRR\\^(1\u002F2));\n* Uncontrolled hypertension (systolic pressure ≥140 mmHg and\u002For diastolic pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment;\n* Unstable angina;\n* Myocardial infarction or coronary artery bypass graft\u002Fstent surgery within 6 months before dosing;\n* Clinically significant valvular disease;\n* Other cardiac diseases deemed unsuitable for enrollment by the investigator; 8. Clinically significant pleural effusion at screening; 9. History of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar disease, or other active CNS diseases; 10. History of deep vein thrombosis or pulmonary embolism within 6 months before screening; 11. Known history of hypersensitivity to any component of the study drug; 12. Live vaccination within 6 weeks before screening; 13. Active infection at screening; 14. Expected lifespan less than 3 months; 15. Participation in another interventional clinical study within 3 months before screening involving investigational drugs not yet marketed, or within 5 half-lives for marketed drugs; or intention to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the study; 16. Other conditions deemed unsuitable for participation by the investigator.","65 Years",{"count":70,"type":21},11,[24],"This is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed\u002Frefractory CD19-positive acute lymphoblastic leukemia.",[74],"Acute Lymphobkastic Leukemia",[76,16],"STR-P004","2025-11-17",{"date":79,"type":32},"2025-11-24",{"date":81,"type":21},"2025-12-03",{"date":83,"type":21},"2026-12-30",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100593187","early-phase-1-a-study-to-evaluate-the-safety-and-clinical-efficacy-of-str-p004-100593187","NCT07003178","A Study to Evaluate the Safety and Clinical Efficacy of STR-P004","An Early Clinical Study to Evaluate the Safety and Clinical Efficacy of STR-P004 in Subjects With Relapsed\u002FRefractory CD19-Positive B-Lymphocytic Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed\u002Frefractory CD19-positive B-cell non-Hodgkin's lymphoma:\n\n  1. Age ≥18 years, regardless of gender;\n  2. Life expectancy \\>12 weeks;\n  3. ECOG score of 0-2;\n  4. Diagnosis of B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to WHO 2016 criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL);\n  5. Pathologically confirmed B-cell non-Hodgkin's lymphoma meeting one of the following conditions:\n\n     1. Relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma with the best response of SD or PD after receiving at least two lines of adequate therapy, the best response of PD during or after the last line of treatment, or the best response of SD after receiving at least two cycles of the last line of treatment;\n     2. For relapse or PD within 12 months after autologous stem cell transplantation (ASCT) for B-cell non-Hodgkin's lymphoma, if salvage therapy is administered, no response (SD\u002FPD) to the last treatment is required; for relapse or PD more than 12 months after ASCT, salvage therapy is needed, and no response (SD\u002FPD) to the last treatment is required;\n  6. Hemoglobin ≥80 g\u002FL, neutrophils ≥1.0 × 109\u002FL, platelets ≥75 × 109\u002FL;\n  7. At least one measurable tumor lesion according to the 2014 Lugano response criteria;\n  8. Hepatic and renal function, as well as cardiopulmonary function, meet the following requirements:\n\n     1. Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin (calculated by the Cockcroft-Gault formula);\n     2. Ejection fraction \\>50%, with no clinically significant pericardial effusion or pleural effusion detected;\n     3. Baseline oxygen saturation \\>92%;\n     4. Total bilirubin ≤1.5 × ULN (≤5 × ULN for Gilbert syndrome);\n     5. ALT and AST ≤3 × ULN (≤5 × ULN for patients with liver metastases).\n  9. Capable of understanding the study and having signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following conditions will not be eligible for participation:\n\n  1. History of malignancies other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), or high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, except for adequately treated cervix carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;\n  2. Presence of any of the following high-risk factors: sum of product of diameters (SPD) of lesions (all measurable lesions ≥1.5 cm in the longest diameter) ≥100 cm; bulky disease (single lesion ≥10 cm); lesions located in the pharynx or trachea with pressure symptom; lesions adjacent to critical hollow organs such as the gastrointestinal tract or bile ducts, where enlargement may press or invade surrounding organs and impair their functions;\n  3. Subjects who have not completed a washout period of at least 5 half-lives since their last anticancer therapy (including I\u002FO therapy) prior to the first dose of study treatment; for anticancer therapies with a half-life \\>5 days, a washout period \\>14 days is acceptable; or participation in any other clinical study within 4 weeks prior to the first treatment;\n  4. Any of the following conditions: positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg); positive for hepatitis B e antibody (HBe-Ab) with HBV-DNA copy number above the lower limit of detection; positive for hepatitis C antibody (HCV-Ab); positive for anti-Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody; EBV-DNA or CMV-DNA copy number above the lower limit of detection;\n  5. Any unstable systemic disease, including but not limited to active infection (except for local infections), 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\\] class ≥III), severe arrhythmia requiring medication, or hepatic, renal, or metabolic disorders;\n  6. Any uncontrolled active condition that may interfere with study participation;\n  7. Any condition deemed by the investigator to compromise subject safety or interfere with the study objective;\n  8. Pregnant or breastfeeding women, or subjects who plan to become pregnant during the treatment period or within 1 year after treatment completion, or male subjects whose partners plan to become pregnant within 1 year after cell infusion;\n  9. Subjects receiving systemic corticosteroid therapy within 14 days prior to enrollment and judged by the investigator to require long-term use of systemic corticosteroid during treatment (excluding inhaled or topical use);\n  10. Presence of central nervous system or brain metastasis symptoms or receiving treatment for central nervous system or brain metastasis (radiotherapy, surgery, or other therapy) within 3 months prior to enrollment;\n  11. Subjects with conditions that impair their ability to provide written informed consent or comply with study procedures, or those unwilling or unable to adhere to study requirements.\n  12. Subjects deemed unsuitable for participation in this study by the investigator.",{"count":93,"type":21},30,[95],"EARLY_PHASE1","This study is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, and pharmacokinetic profile of STR-P004 in subjects with relapsed\u002Frefractory CD19-positive B-cell non-Hodgkin lymphoma, and preliminarily observing its antitumor activity.",[98],"Non Hodgkin Lymphoma","2025-06-03",{"date":101,"type":32},"2025-06-04",{"date":103,"type":21},"2025-06",{"date":105,"type":21},"2027-05",{"name":38,"class":39},1,""]