[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Immunochina Medical Science & Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":208},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,68,91,116,138,161,186],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100624234","phase-1-clinical-study-of-im96-car-t-cell-therapy-in-patients-with-advanced-adenocarcinoma-of-gastricesophagogastric-junction-100624234",false,"NCT07406984","Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Adenocarcinoma of Gastric\u002FEsophagogastric Junction","A Phase I Clinical Study to Evaluate the Safety and Efficacy of IM96 CAR-T Cell Injection in Advanced Adenocarcinoma of Gastric\u002FEsophagogastric Junction","Inclusion Criteria:\n\n1. The age is 18 to 75 years (including boundary values) and the gender is not limited;\n2. Patients with advanced locally inoperable or metastatic adenocarcinoma of the stomach\u002Fgastric esophageal junction diagnosed by pathohistology;\n3. Patients with metastatic stomach\u002Fgastric esophageal junction who have failed or are intolerant to standard therapy;\n\n   Notes:\n   1. The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Gastric Cancer, 2025 Edition;\n   2. The standard prior treatment regimen should incorporate therapeutic strategies guided by relevant molecular biomarkers. Specifically, patients with HER2-positive tumors must have received HER2-targeted therapy;\n   3. Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow suppression, etc., and who do not accept refusal for financial and personal reasons;\n4. Presence of at least one measurable lesion that meets RECIST 1.1 criteria;\n5. Patients must provide a tumor sample within 2 years that meets the requirements (paraffin block or number of unstained sections that meet the testing requirements set by the Institute) that is positive for GUCY2C expression by immunohistochemistry;\n6. Eastern cooperative oncology group (ECOG) score of 0-1;\n7. Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception during the trial and up to the last follow-up visit;male patients whose partners are of childbearing potential agree to use effective contraception during the trial and up to the last follow-up visit;\n8. Laboratory tests should meet at least the indicators specified below:\n\n   Hemoglobin (Hb) ≥ 80 g\u002FL; Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\\^9\u002FL; Platelet count (PLT) ≥ 75 x 10\\^9\u002FL; Absolute lymphocyte value ≥ 0.6 x 10\\^9\u002FL; Lymphocytes make up ≥10% of white blood cells; Creatinine clearance ≥60 ml\u002Fmin; Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and ALT can be adjusted upward to 5-fold, and the high limit for TBL may be adjusted upward to 3-fold; Serum albumin ≥ 3.0 g\u002FdL; Prolongation of prothrombinogen time ≤ 4s;\n9. Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment;\n10. Oxygen saturation \\>92% in non-oxygenated state;\n11. Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters;\n12. Those who voluntarily participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of brain metastases;\n2. Patients who have previously received or are awaiting an organ transplant;\n3. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);\n4. Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;\n5. Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;\n6. Lung diseases that the inversgaters determined were not suitable for inclusion in the study;\n7. Use of any of the following medications or treatments during the designated time period prior to cell collection:\n\n   1. Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;\n   2. Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;\n   3. Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n   4. Use of study drug within 4 weeks prior to cell collection.However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to cell collection;\n   5. Received interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;\n   6. Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;\n   7. Received targeted drug treatment such as apatinib or fuyiquatine within one week prior to cell collection;\n   8. Received immunotherapy drugs such as anti-PD-1\u002FPD-L1 within four weeks prior to cell collection;\n8. Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);\n9. Those who have received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc;\n10. Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage\u002Fcerebral infarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury,dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;\n11. Chronic or active infection requiring systemic therapy and history of symptomatic viral infection that has not been completely cured. For example, Hepatitis B: patients who are positive for Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection;patients who are positive for Hepatitis C Virus Antibody (HCVAb) and whose peripheral blood HCV-RNA test is above the lower limit of detection; and patients infected with Human Immunodeficiency Virus (HIV), Syphilis;\n12. Active EBV and cytomegalovirus, defined as patients with IgM antibodypositive or IgM antibody-negative but higher-than-normal EBV-DNA in EBV serum; and cytomegalovirus (CMV) seropositive or IgM antibodynegative but higher-than-normal CMV-DNA in serum;\n13. Vaccination with live vaccine within 6 weeks prior to the start of screening;\n14. Abnormalities of cardiac function include: long QTc syndrome or QTc interval \\>480 ms; complete left bundle branch block, degree II\u002FIII AV block; severe, uncontrolled arrhythmias requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 3) with a cardiac ejection fraction of less than 50% in the 6 months prior to screening; CTC AE ≥3 grade heart valve disease;myocardial infarction, cardiac angioplasty or stenting,unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;\n15. Patients requiring anticoagulation therapy;\n16. Requires long-term use of medications that can affect clotting (e.g.,aspirin, warfarin, etc.);\n17. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;\n18. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n19. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;\n20. Patients with digestive tract obstruction;\n21. The primary lesion exhibits a large ulcer, conferring a high risk of hemorrhage or perforation; alternatively, imaging studies (CT or MRI), with or without adjunctive gastroscopy, demonstrate transmural tumor invasion-i.e., infiltration across the full thickness of the gastric wall-thereby elevating the patient's risk of hemorrhage or perforation;\n22. Patients present with unstable or active peptic ulcers, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the preceding three months;\n23. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n24. The presence of any factors affecting compliance with the protocol or the patient's unwillingness or inability to comply with the procedures required in the study protocol, as determined by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced adenocarcinoma of gastric\u002Fesophagogastric junction",[27,28],"Adenocarcinoma of Gastric","Adenocarcinoma of Esophagogastric Junction",[30,31],"Advanced adenocarcinoma of gastric IM96 CAR-T","Advanced adenocarcinoma of esophagogastric junction IM96 CAR-T","NOT_YET_RECRUITING","2026-02-11",{"date":35,"type":36},"2026-02-13","ACTUAL",{"date":38,"type":21},"2026-03-05",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Beijing Immunochina Medical Science & Technology Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100584252","early-phase-1-clinical-study-evaluating-the-safety-and-efficacy-of-ic19-car-t-cell-therapy-for-refractory-systemic-lupus-erythematosus-100584252","NCT06886919","Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus","IC19 CAR-T","Inclusion Criteria:\n\n1. Subjects diagnosed with systemic lupus erythematosus who meet the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE;\n2. Prior to screening, treatment with glucocorticoids (sufficient or shock therapy) combined with immunosuppressants (cyclophosphamide, mycophenolate mofetil, antimalarial drugs, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) and at least one biological agent (rituximab, belimumab, tacrolizumab, etc.) must have been received for at least 2 months, and the dosage must be stable for more than 2 weeks. The disease should still be active or recur after disease remission.\n\nOral corticosteroids need to meet the following conditions:\n\n1. Prednisone (or equivalent) ≥ 7.5 mg\u002Fday and ≤ 60 mg\u002Fday;\n2. When used in combination with immunosuppressants and\u002For biologics, there is no minimum daily dose requirement for glucocorticoids.\n\n3\\. When screening, the disease activity score (SLEDAI-2000) should be ≥ 8 points; 4. During the screening period, it meets the criteria of being positive for anti nuclear antibodies (ANAs), anti dsDNA antibodies, or anti Smith antibodies.\n\n5\\. Age range of 18-70 years old (including threshold), gender not limited; 6. Expected survival period of more than 3 months; 7. The functions of important organs meet the following requirements:\n\n1. The bone marrow function needs to meet the following requirements: a. Neutrophil count ≥ 1 × 109\u002FL; b. Platelets ≥ 50 × 109\u002FL; c. Hemoglobin ≥ 60g\u002FL;\n2. Liver function: ALT ≤ 2.5 × ULN (upper limit of normal, ULN), AST ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN (for subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN);\n3. Renal function: creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 40 ml\u002Fmin (Cockcroft\u002FGault formula);\n4. Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;\n5. Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 50%;\n6. Finger pulse oxygen saturation ≥ 92% in non oxygen state; 8. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to participate in the trial until the last time Visit individuals who have adopted effective contraceptive measures; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up; And not in the lactation period.\n\n9\\. The individual or legal guardian agrees to participate in this experiment and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Diseases of the central nervous system that have clinical significance in the past or during screening, such as seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or psychiatric disorders;\n2. Screening for acute severe lupus nephritis within the first 2 months, defined as significant deterioration of kidney disease (such as the presence of urine sediment and other laboratory abnormalities) that the researcher believes may require the use of contraindicated drugs or high-dose corticosteroids (prednisone ≥ 100 mg\u002Fd or equivalent corticosteroid treatment ≥ 14 days) for treatment in the first 2 months of the study.\n3. If there is an uncontrolled lupus crisis within the first 2 months of screening, the researcher has assessed that it is not suitable to participate in this study;\n4. A large amount of serous fluid accumulation (such as pleural effusion and peritoneal effusion) with compression symptoms that cannot be controlled after treatment;\n5. Other active autoimmune diseases (such as Crohn's disease and rheumatoid arthritis) that require systemic immunosuppressive therapy within the first 2 years of screening, except for SLE;\n6. Patients who have received or are waiting for hematopoietic stem cell\u002Fbone marrow transplantation or organ transplantation in the past;\n7. Individuals who have previously received gene modified cell therapy, such as TCR-T therapy, CAR-T therapy, etc;\n8. Screening for clinical study drugs used for any other autoimmune diseases within the first 3 months. But if the research treatment is ineffective or if the disease progresses, and at least 5 half lives have passed before screening, it is allowed to be included in the group;\n9. Have a history of ≥ grade 2 bleeding within 30 days prior to screening, or require long-term continuous use of anticoagulant drugs (such as warfarin, low molecular weight heparin, or Xa factor inhibitors) for treatment;\n10. Vaccination with live or attenuated vaccines within 6 weeks prior to screening;\n11. Active hepatitis B or hepatitis C virus is defined as: subjects who are positive for hepatitis B B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA detection is higher than the lower limit of detection (HBsAg positive but whose peripheral blood HBV-DNA detection is lower than the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, Version 2022, at least 4 weeks of antiviral treatment shall be carried out before the first use of the study drug, and antiviral treatment shall be continued for 6-12 months during the study process, and the levels of HBV-DNA, HBsAg and ALT shall be monitored every 1-3 months); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV-RNA detection above the detection limit; HIV antibody positive; Positive syphilis antibody;\n12. Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);\n13. Within the past year, there have been severe chronic obstructive pulmonary disease, interstitial lung disease, severe asthma, and clinically significant abnormalities in lung function tests, such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography\\>60mmHg) that require oxygen storage mask oxygen therapy or non-invasive or invasive ventilator assisted breathing during screening; Interstitial lung disease related to autoimmune diseases must meet all inclusion criteria;\n14. Hypertension with poor drug control (systolic blood pressure\\>160mmHg and\u002For diastolic blood pressure\\>90mmHg) or a history of any of the following cardiovascular diseases within 6 months prior to screening: long QTc syndrome or QTc interval\\>480 ms; Complete left bundle branch block, grade II\u002FIII atrioventricular block; Severe and uncontrolled arrhythmias requiring medication treatment; History of chronic congestive heart failure and NYHA ≥ 3 (refer to Appendix 2) with a heart ejection fraction below 50% within the 6 months prior to screening; Heart valve disease with CTCAE ≥ 3 grade; Within the first 6 months of screening, there has been a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart diseases;\n15. History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;\n16. Other untreated malignant tumors within the past 5 years or simultaneously, excluding cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n17. Infections (fungi, bacteria, viruses, or others) that require intravenous injection of antibiotics for control or are uncontrollable For simple urinary tract infections and bacterial pharyngitis, if the researchers evaluate that they can be controlled through treatment, they can be included in the study;\n18. Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any ingredients of drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab, albumin), or who have previously experienced severe allergic reactions;\n19. Have a history of alcohol or drug abuse in the past 24 weeks;\n20. The researcher shall determine whether the subjects have any factors that affect compliance with the protocol, or are unwilling or unable to comply with the procedures required in the research protocol.","70 Years",{"count":54,"type":21},6,[56],"EARLY_PHASE1","This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T cell single pulse infusion therapy.",[59],"Difficult to Treat Systemic Lupus Erythematosus","2025-03-19",{"date":62,"type":36},"2025-03-24",{"date":64,"type":21},"2025-03-31",{"date":66,"type":21},"2026-05-30",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100581612","phase-1-clinical-study-of-zm001-injection-in-the-treatment-of-refractory-systemic-lupus-erythematosus-100581612","NCT06852573","Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus","A Phase I Clinical Study to Evaluate the Safety and Efficacy of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Subjects with a diagnosis of systemic lupus erythematosus according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) SLE classification criteria;\n2. This trial enrolled patients with refractory SLE and required the following prior treatment history for refractory patients:\n\n   1. Adequate standard therapeutic doses of glucocorticoids, immunosuppressants, and at least one biologic therapy combination regimen for at least 2 months prior to screening are required, and the dose is stable for \\>2 weeks and the disease remains moderately to severely active.\n   2. Immunosuppressants: at least one or more of cyclophosphamide, mycophenolic acids, azathioprine, and calcineurin phosphatase inhibitors have been used;\n   3. Biologics: at least one or more of belimumab, tetracycline, rituximab;\n   4. Oral glucocorticoids must meet the following requirements:\n   5. Prednisone (or equivalent) ≥ 7.5 mg\u002Fday and ≤ 60 mg\u002Fday;\n   6. There is no minimum daily dose requirement for glucocorticoids when used in combination with immunosuppressive and\u002For biological agents.\n3. Compliance at screening: positive anti-nuclear antibodies (ANAs) or positive anti-dsDNA antibodies or positive anti-Smith antibodies;\n4. SLEDAI-2000 score ≥7 at screening or combination of vital organs, such as severe immune thrombocytopenia (platelets \\\u003C30\\*×10\\^9\u002FL or \\\u003C50\\*×10\\^9\u002FL with bleeding tendency);\n5. Age 18-70 (including boundary values), male and female;\n6. Survival is expected to be more than 3 months;\n7. Women of childbearing potential who had a negative blood pregnancy test prior to the start of the trial and who agreed to use effective contraception for the duration of the trial up to the last follow-up visit; male subjects whose partners were of childbearing potential agreed to use effective contraception for the duration of the trial up to the last follow-up visit;\n8. Blood cell analysis within 3 days prior to single collection:\n\n   1. Hemoglobin (Hb) ≥ 80 g\u002FL;\n   2. Neutrophils (Absolute neutrophil count (ANC)) ≥ 1.5 x 109\u002FL;\n   3. Platelet count (PLT) ≥ 20 x 109\u002FL;\n   4. Absolute lymphocyte count ≥ 0.6 x 109\u002FL and percentage of lymphocytes ≥ 10%;\n9. Liver, kidney, heart, lung function, and coagulation meet the following requirements:\n\n   1. Creatinine clearance ≥ 40 ml\u002Fmin or serum creatinine ≤ 1.5 x upper limit of normal (ULN);\n   2. ALT, AST ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's syndrome, ALT, AST ≤ 5 x ULN and total bilirubin ≤ 3 x ULN);\n   3. International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;\n   4. Left ventricular ejection fraction ≥ 50%;\n   5. Finger pulse oximetry saturation \\>92% in non-oxygenated state;\n10. Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters;\n11. The person himself\u002Fherself or his\u002Fher legal guardian agrees to participate in this trial and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Pre-existing or clinically significant CNS disorders not due to lupus at the time of screening, such as convulsive seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, encephalitis, CNS vasculitis, or psychiatric disorders; epilepsy due to lupus, stable without seizures for a period of 1 year prior to the screening period Stable seizure-free for 1 year may also be screened.\n2. Treatment with hemodialysis, or high-dose corticosteroids (prednisone ≥1.5 mg\u002Fkg\u002Fd or equivalent glucocorticoid therapy for ≥14 days) was required within 2 months prior to screening.\n3. Presence of still uncontrolled lupus crisis within 2 months prior to screening that is assessed by the investigator to be unsuitable for participation in this study;\n4. Massive plasmapheresis (e.g., pleural effusion, abdominal effusion) with symptoms of compression that cannot be controlled with treatment;\n5. Active autoimmune disease other than SLE (e.g., Crohn's disease, rheumatoid arthritis) requiring systemic immunosuppressive therapy within 2 years prior to the start of screening;\n6. Patients who have previously received or are awaiting hematopoietic stem cell\u002Fbone marrow transplantation or organ transplantation;\n7. Those who have received prior genetically modified cell therapy, such as TCR-T therapy, CAR-T therapy, etc;\n8. Use of any other clinical investigational drug for the treatment of SLE within 4 weeks prior to screening. However, treatment ineffectiveness or disease progression that has passed at least 3 half-lives prior to screening will allow enrollment;\n9. History of grade ≥2 bleeding within 30 days prior to screening or need for long-term continuous treatment with anticoagulants (e.g., warfarin, low molecular heparin, or factor Xa inhibitors);\n10. Plasma exchange, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 14 days prior to cell collection;\n11. Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n12. Live or live attenuated vaccine within 6 weeks prior to screening;\n13. Active hepatitis B or hepatitis C virus, defined as subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection (HBsAg-positive but with a peripheral blood HBV-DNA test below the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, 2022 Edition, at least 4 weeks of antiviral therapy prior to the first administration of the investigational drug, and continued antiviral therapy for 6 to 6 months during the study, with monitoring of HBV DNA and ALT levels required may be every 1\\~month. Antiviral therapy for at least 4 weeks prior to the first dose of study drug and continued for 6-12 months during the course of the study, with monitoring of HBV DNA, HBsAg, and ALT levels at 1-3 month intervals); Hepatitis C Virus (HCV) antibody-positive subjects with a peripheral blood HCV-RNA test higher than the lower limit of detection; HIV antibody-positive subjects; and syphilis antibody-positive subjects;\n14. Active EBV and cytomegalovirus, defined as subjects with IgM antibody-positive or IgM antibody-negative EBV serum but higher-than-normal EBV-DNA; and cytomegalovirus (CMV) serum IgM antibody-positive or IgM antibody-negative cytomegalovirus but higher-than-normal CMV-DNA;\n15. Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;\n16. Medically uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or a history of any of the following cardiovascular diseases within 6 months prior to the start of screening: long QTc syndrome or QTc interval \\>480 ms; complete left bundle branch block, second\u002Fthird degree atrioventricular block; severe uncontrolled cardiac arrhythmias that require medication; history of chronic congestive heart failure with NYHA class ≥3 (refer to Appendix 2) cardiac ejection fraction less than 50% within 6 months prior to screening; CTCAE ≥3; CTCAE ≥3; and CTCAE ≥3. controlled arrhythmia; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 2) cardiac ejection fraction less than 50% within 6 months prior to screening; CTCAE class ≥3 cardiac valvular disease; myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;\n17. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;\n18. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n19. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;\n20. The presence of any factors affecting compliance with the protocol, or the unwillingness or inability of the subject to comply with the procedures required in the study protocol, as judged by the investigator.",{"count":20,"type":21},[24],"This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus",[79],"Systemic Lupus Erythematosus",[81,82],"ZM001 CD19 CAR-T","refractory systemic lupus erythematosus","2025-02-24",{"date":85,"type":36},"2025-02-28",{"date":87,"type":21},"2025-02-20",{"date":89,"type":21},"2027-08-20",{"name":42,"class":43},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100571321","phase-1-clinical-study-of-im96-car-t-cell-therapy-in-patients-with-advanced-colorectal-cancer-100571321","NCT06718738","Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer","A Phase I Clinical Study to Evaluate the Safety and Efficacy of IM96 CAR-T Cell Injection in Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. The age is 18 to 75 years (including boundary values) and the gender is not limited;\n2. Patients with advanced GI tumors diagnosed by pathohistology, mainly:\n\n(1)Patients with metastatic colorectal cancer who have failed or are intolerant to second-line and above standard therapy;\n\nNotes:\n\n1. The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Colorectal and Gastric Cancer, 2024 Edition;\n2. Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow suppression, etc., and who do not accept refusal for financial and personal reasons; 3.Presence of at least one measurable lesion that meets RECIST 1.1 criteria; 4.Patients must provide a tumor sample within 2 years that meets the requirements (paraffin block or number of unstained sections that meet the testing requirements set by the Institute) that is positive for GUCY2C expression by immunohistochemistry; 5.Survival is expected to be more than 3 months; 6.Eastern cooperative oncology group (ECOG) score of 0-1 (refer to Attachment 2); 7.Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception during the trial and up to the last follow-up visit; male patients whose partners are of childbearing potential agree to use effective contraception during the trial and up to the last follow-up visit 8.Laboratory tests should meet at least the indicators specified below:\n\n   1. Hemoglobin (Hb) ≥ 90 g\u002FL;\n   2. Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\\^9\u002FL;\n   3. Platelet count (PLT) ≥ 75 x 10\\^9\u002FL;\n   4. Absolute lymphocyte value ≥ 0.6 x 10\\^9\u002FL;\n   5. Lymphocytes make up ≥10% of white blood cells;\n   6. Creatinine clearance ≥60 ml\u002Fmin;\n   7. Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and ALT can be adjusted upward to 5-fold, and the high limit for TBL may be adjusted upward to 3-fold;\n   8. Serum albumin ≥ 3.0 g\u002FdL.\n   9. Prolongation of prothrombinogen time ≤ 4s; 9.Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment; 10.Oxygen saturation \\>92% in non-oxygenated state; 11.Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters; Those who voluntarily participate in the trial and sign the informed consent form\n\nExclusion Criteria:\n\n1. Presence of brain metastases;\n2. Patients who have previously received or are awaiting an organ transplant;\n3. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);\n4. Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;\n5. Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;\n6. Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;\n7. Use of any of the following medications or treatments during the designated time period prior to cell collection:\n\n   1. Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;\n   2. Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;\n   3. Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n   4. Use of study drug within 4 weeks prior to cell collection. However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to cell collection;\n   5. Received interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;\n   6. Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;\n   7. Received treatment with targeted agents such as regorafenib, furaquintinib, etc. within 1 week prior to cell collection;\n8. Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);\n9. Those who have received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc;\n10. If immunotherapy such as anti-PD1 and PD-L1 has been used prior to IM96 CAR-T cell transfusion, at least 5 half-lives must have elapsed after the last dose and before IM96 CAR-T cell transfusion;\n11. Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage\u002Fcerebral infarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;\n12. Chronic or active infection requiring systemic therapy and history of symptomatic viral infection that has not been completely cured. For example, Hepatitis B: patients who are positive for Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) and whose peripheral blood HBV-DNA test is above the lower limit of detection; patients who are positive for Hepatitis C Virus Antibody (HCVAb) and whose peripheral blood HCV-RNA test is above the lower limit of detection; and patients infected with Human Immunodeficiency Virus (HIV), Syphilis;\n13. Active EBV and cytomegalovirus, defined as patients with IgM antibody-positive or IgM antibody-negative but higher-than-normal EBV-DNA in EBV serum; and cytomegalovirus (CMV) seropositive or IgM antibody-negative but higher-than-normal CMV-DNA in serum;\n14. Vaccination with live vaccine within 6 weeks prior to the start of screening;\n15. Abnormalities of cardiac function include: long QTc syndrome or QTc interval \\>480 ms; complete left bundle branch block, degree II\u002FIII AV block; severe, uncontrolled arrhythmias requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Attachment 3) with a cardiac ejection fraction of less than 50% in the 6 months prior to screening; CTC AE ≥3 grade heart valve disease; myocardial infarction, cardiac angioplasty or stenting, unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;\n16. Patients requiring anticoagulation therapy;\n17. Requires long-term use of medications that can affect clotting (e.g., aspirin, warfarin, etc.);\n18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;\n19. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n20. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;\n21. Patients with digestive tract obstruction;\n22. Patients at high risk for bleeding or perforation;\n23. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study; The presence of any factors affecting compliance with the protocol or the patient's unwillingness or inability to comply with the procedures required in the study protocol, as determined by the investigator",{"count":99,"type":21},9,[24],"This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced colorectal cancer",[103],"Colorectal Cancer (CRC)",[105,106],"Advanced colorectal cancer","IM96 CAR-T","RECRUITING","2024-12-02",{"date":110,"type":36},"2024-12-05",{"date":112,"type":21},"2024-12-15",{"date":114,"type":21},"2026-08-15",{"name":42,"class":43},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100569139","early-phase-1-im19-car-t-cell-therapy-for-iga-nephropathy-patients-and-membranous-nephropathy-patients-100569139","NCT06690359","IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients","Evaluation of IM19 CAR-T Cell Therapy for IgA Nephropathy With Urinary Protein and Renal Dysfunction Safety and Efficacy of Patients With Primary Membranous Nephropathy and Those at Medium to High Risk Clinical Research","Inclusion Criteria：\n\n* IgA nephropathy\n\n  1. IgA nephropathy diagnosed through renal biopsy\n  2. When screening, urine protein should be ≥0.5g\u002FgCr and 20mL\u002Fmin\u002F1.73m\\^2≤eGFR\\\u003C60mL\u002Fmin\u002F1.73m\\^2\n  3. Age≥18years old\n  4. Liver, kidney, heart, lung function, and coagulation function meet the following requirements:\n\n     4.1 ALT and AST ≤ 2.5 × ULN,total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN); 4.2 Left ventricular ejection fraction ≥ 50%; 4.3 International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4.4 Finger pulse oxygen saturation\\>92% in non oxygen state;\n  5. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;\n  6. Doctors evaluate patients with the optimal benefit risk ratio\n  7. Those who voluntarily participate in this experiment and sign the informed consent form\n* Primary membranous nephropathy:\n\n  1. Diagnosis of primary membranous nephropathy through renal biopsy;\n  2. Primary membranous nephropathy at medium or high risk that has not improved after 6 months of treatment with CNI and rituximab:\n\n     2.1. Moderate risk assessment criteria 2.1.1. EGFR is normal, 24-hour urine protein is\\>4g, and conservative treatment with angiotensin-converting enzyme inhibitors\u002Fangiotensin receptor blockers has been continuously used for 6 months or more before screening. The 24-hour urine protein has not decreased by less than 50% 2.1.2. PLA2R antibody\\\u003C50RU\u002FmL+ 2.1.3. Low molecular weight urinary protein 2.1.4. Selectivity index\\\u003C0.15 2.1.5. Urinary immunoglobulin UIgG\\\u003C250mg\u002Fday 2.2 High risk assessment criteria 2.2.1. eGFR\\\u003C60ml\u002Fmin\u002F1.73m\\^2 2.2.2. 24-hour urine protein\\>4g and lasting\\>6 months 2.2.3. PLA2R antibody\\>150RU\u002FmL+ 2.2.4. High molecular weight urinary protein 2.2.5. Urine immunoglobulin UigG\\>250mg\u002Fday 2.2.6. Selectivity index\\>0.20\n  3. Age ≥ 18 years old;\n  4. Liver, heart, lung function, and coagulation function meet the following requirements:\n\n     4.1. ALT and AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN (for) Subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN); 4.2. Left ventricular ejection fraction ≥ 50%; 4.3. International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4.4. Finger pulse oxygen saturation\\>92% in non oxygen state\n  5. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up\n  6. Doctors evaluate patients with the optimal benefit risk ratio\n  7. Those who voluntarily participate in this experiment and sign the informed consent form\n\nExclusion Criteria:\n\n* IgA nephropathy:\n\n  1. Kidney diseases other than IgA nephropathy, as well as primary and secondary nephrotic syndrome\n  2. After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations)\n  3. Serious complications unrelated to IgA nephropathy\n  4. Use or increase the dosage of corticosteroids, immunosuppressants, biologics (including but not limited to CD20 monoclonal antibodies, taceptil, etc.), anticoagulants (warfarin), and n-3 fatty acids (fish oil) for the drug treatment of IgA nephropathy within 3 months\n  5. Uncontrollable hypertension or hyperglycemia\n  6. Perform palatal tonsillectomy within 6 months\n  7. Study subjects with a history of alcohol or drug abuse within the past 24 weeks\n  8. Have undergone major surgery (including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment in the study\n  9. Used other cell therapies\n  10. Have participated in or participated in other clinical trials within the past 3 months\n  11. Within 3 years or planning to undergo a kidney transplan\n  12. Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and\u002For hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals\n  13. Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV)\n  14. Serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n      14.1. Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; 14.2. At rest, QT interval prolongation (QTc\\>450 milliseconds in males or\\>470 milliseconds in females); 14.3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; 14.4. There is heart failure with NYHA functional class ≥ II in the United States;\n  15. History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;\n  16. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) (unless in a disease-free state for at least 3 years)\n  17. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment\n  18. The researchers believe that it does not meet the criteria for joining this clinical trial\n  19. During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.\n* Primary membranous nephropathy:\n\n  1. Secondary membranous nephropathy;\n  2. Urinary protein decreased by more than 50% within the first 6 months of screening;\n  3. After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations);\n  4. Serious complications unrelated to primary membranous nephropathy;\n  5. Uncontrollable hypertension or hyperglycemia;\n  6. The study subjects have a history of alcohol or drug abuse within the past 24 weeks;\n  7. Have undergone major surgery (including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment in the study;\n  8. Have used other cell therapies;\n  9. Have participated in or taken part in other clinical trials within the past 3 months;\n  10. Within 3 years or planning to undergo kidney transplantation;\n  11. Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and\u002For hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals;\n  12. Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);\n  13. History of serious cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; At rest, QT interval prolongation (QTc\\>450 milliseconds in males or\\>470 milliseconds in females); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; There is heart failure with NYHA functional class ≥ II in the United States;\n  14. History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;\n  15. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervix, bladder, breast) (unless in a disease-free state for at least 3 years);\n  16. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment;\n  17. The researcher believes that it does not meet the criteria for joining this clinical trial;\n  18. During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.",{"count":124,"type":21},12,[56],"IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy",[128,129],"IgA Nephropathy","Membranous Nephropathy","2024-11-25",{"date":132,"type":36},"2024-11-26",{"date":134,"type":21},"2024-12-13",{"date":136,"type":21},"2026-12-20",{"name":42,"class":43},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100569212","early-phase-1-wl276-car-t-cell-therapy-for-cd276-positive-recurrent-or-progressive-glioblastoma-patients-100569212","NCT06691308","WL276 CAR-T Cell Therapy for CD276 Positive Recurrent or Progressive Glioblastoma Patients","Clinical Study Evaluating the Safety and Efficacy of WL276 CAR-T Cell Therapy in CD276 Positive Recurrent or Progressive Glioblastoma Patients","Inclusion Criteria:\n\n1. Diagnosed with glioblastoma through histopathological examination;\n2. Patients with unresectable recurrent or progressive glioblastoma who have failed or are intolerant to standard treatment; 8.1The standardized systematic treatment received by patients must comply with the 2022 edition of the \"Guidelines for the Treatment of Gliomas\"; 8.2Requirements for treating intolerance: Refers to patients who are unable to continue the current effective systemic standardized treatment due to toxic side effects such as vomiting, diarrhea, abdominal pain, bone marrow suppression, etc. of grade ≥ 3. Refusal due to economic or personal reasons is not accepted;\n3. Age ≥ 18 years old, including boundary values;\n4. Expected survival period greater than 2 months;\n5. There is at least one measurable intracranial lesion that meets the criteria of Neuro Tumor Response Evaluation (RANO);\n6. Patients must provide tumor samples within 2 years that meet the requirements (paraffin blocks or unstained sections with a quantity that meets the testing requirements specified in this study) and have positive CD276 expression detected by immunohistochemistry;\n7. Karnofsky (KPS) functional status score ≥ 60 points;\n8. Blood routine:\n\n   8.1Hemoglobin (Hb) ≥ 90g\u002FL; 8.2Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9\u002FL; 8.3Platelet count (PLT) ≥ 70 × 10 \\^ 9\u002FL; 8.4Absolute value of lymphocytes ≥ 0.5 × 10 \\^ 9\u002FL;\n9. The liver, kidney, heart, and lung functions meet the following requirements:\n\n   9.1Creatinine clearance rate ≥ 60ml\u002Fmin; 9.2Alanine transaminase (ALT) and aspartate transaminase 9.3Aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBL) ≤ 1.5 × ULN (for the elevation of ALT and AST that can be explained by liver invasion, AST and ALT high limit can be upregulated up to 5-fold, and TBL high limit can be upregulated up to 3-fold); 9.4Serum albumin ≥ 3.0g\u002FdL; 9.5Left ventricular ejection fraction ≥ 50%, no pericardial effusion \\[ECHO (Echocardiography, ECHO) examination\\], no clinically significant ECG (Electrocardiogram, ECG) results; 9.6Blood oxygen saturation is greater than 95% under non oxygen inhalation conditions.\n10. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;\n11. Those who voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who require the use of immunosuppressants; Or individuals with autoimmune diseases;\n2. Patients who have received or are waiting for organ transplantation in the past;\n3. The toxicity caused by previous treatment has not stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant);\n4. There is a large amount of uncontrollable serosal fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion) after treatment;\n5. Use any of the following drugs or treatment methods within the specified time before cell collection:\n\n   5.1Used therapeutic doses of corticosteroids within one week prior to cell collection. But the use of topical and inhaled steroids is allowed; 5.2Received chemotherapy drugs within one week prior to cell collection. If the oral chemotherapy drug has passed at least 3 half lives before cell collection, it is allowed to be included in the group; 5.3Individuals who use drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;\n6. CNS diseases that have clinical significance in the past or screening, and have been assessed by researchers as having safety risks;\n7. Individuals who have previously used any gene therapy products;\n8. Active hepatitis B or hepatitis C virus is defined as: subjects who are positive for hepatitis B B virus surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) and whose peripheral blood HBV DNA titer is higher than the upper limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); People infected with AIDS virus and syphilis;\n9. Active EBV and cytomegalovirus are defined as patients with positive or negative IgM antibodies in EBV serum but EBV-DNA levels higher than normal; Patients with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);\n10. Used the research drug within 4 weeks prior to cell collection. But if the experimental treatment is ineffective or if the disease progresses, and at least 5 half lives have passed before cell collection, it is allowed to be included in the group;\n11. Received radiation therapy within 4 weeks prior to cell collection;\n12. Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period;\n13. If immunotherapy such as anti-PD1 and PD-L1 has been used before cell infusion, at least 5 half lives must be passed between the last dose and CAR-T cell infusion;\n14. Abnormal cardiac function includes: long QTc syndrome or QTc interval\\>480 ms; Complete left bundle branch block, grade II\u002FIII atrioventricular block; Severe and uncontrolled arrhythmias requiring medication treatment; History of chronic congestive heart failure and NYHA ≥ 3 (refer to Appendix 4) with a heart ejection fraction below 50% within the 6 months prior to screening; Heart valve disease with CTCAE ≥ 3 grade; Within the first 6 months of screening, there has been a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, severe pericardial disease, or other clinically significant heart diseases;\n15. Patients who require anticoagulant therapy;\n16. Patients requiring long-term antiplatelet therapy;\n17. Start screening for symptomatic history of venous thrombosis or pulmonary embolism within the previous 6 months;\n18. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervical, bladder, breast) (unless in a disease-free state for at least 3 years);\n19. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, can be included if the researcher evaluates that they can be controlled through treatment;\n20. Unable to perform MRI examination (such as installing pacemakers, metal dentures, etc.)\n21. The researcher shall determine whether the patient has any factors that affect compliance with the protocol, or is unwilling or unable to comply with the procedures required in the research protocol.",{"count":54,"type":21},[56],"Clinical study evaluating the safety and efficacy of WL276 CAR-T cell therapy in CD276 positive recurrent or progressive glioblastoma patients",[149],"Recurrent or Progressive Glioblastoma",[151,152],"WL276 CAR-T cells","CD276 positive","2024-11-14",{"date":155,"type":36},"2024-11-18",{"date":157,"type":21},"2024-11-12",{"date":159,"type":21},"2027-05-31",{"name":42,"class":43},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":44},"100547783","phase-1-im83-clinical-study-of-car-t-cell-therapy-in-patients-with-relapsed-or-refractory-osteosarcoma-100547783","NCT06412458","IM83 Clinical Study of CAR-T Cell Therapy in Patients With Relapsed or Refractory Osteosarcoma","Phase I Clinical Study to Evaluate the Safety and Efficacy of IM83 CAR-T Cells for the Treatment of Relapsed or Refractory Osteosarcoma","Inclusion Criteria:\n\n1. Age ≥ 16 years, both male and female;\n2. Subjects with a diagnosis of osteosarcoma of the extremity confirmed by pathohistologic examination;\n3. To enroll subjects with recurrent or refractory extremity osteosarcoma who have failed or are intolerant to first-line standard therapy and who are not candidates for radical surgery and\u002For localized therapy and who lack effective subsequent treatment.\n\nNotes:\n\n1. Standard treatment failure was defined as disease relapse or progression during or within 6 months of completion of treatment with first-line chemotherapeutic agents (including high-dose methotrexate, doxorubicin, cisplatin, isocyclophosphamide, etc.);\n2. Requirement of treatment intolerance: means that the subject is unable to continue the current effective systemic regimen due to the development of toxic side effects such as ≥ grade 3 vomiting, diarrhea, abdominal pain, myelosuppression, etc., and that refusal is not accepted for financial and personal reasons;\n3. The standard treatment received by the subject must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Bone and Soft Tissue Tumors, 2023 Edition; 4. At least one measurable target lesion according to RECIST 1.1 criteria; 5. Subjects must provide a tumor tissue sample (paraffin block or number of unstained sections meeting the testing requirements specified by the Institute) within 2 years that meets the requirements to be tested by immunohistochemistry for GPC3 and CD40 and needs to be positive for GPC3 expression;; 6. Karnofsky functional status score ≥60; 7. Expected survival ≥ 12 weeks; 8. Laboratory tests should meet at least the indicators specified below:\n\n1)Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL; 2)Absolute lymphocyte cell count (LY) ≥ 0.6 x 10\\^9\u002FL; 3)Lymphocytes make up ≥10% of white blood cells; 4)Platelets ≥75 x 10\\^9\u002FL; 5)Hemoglobin ≥ 90 g\u002FL; 6)Creatinine clearance ≥60 ml\u002Fmin; 7)Serum bilirubin ≤ 1.5 times the upper limit of normal; if liver metastases are present, serum bilirubin ≤ 3.0 times the upper limit of normal; 8)Prolongation of prothrombinogen time ≤ 4s; 9)≤ 2.5 times the upper limit of normal for albumin transaminase (AST) and albumin transaminase (ALT); if liver metastases are present, ALT and\u002For AST ≤ 5.0 times the upper limit of normal; 9. Left ventricular ejection fraction was \\>50%; 10. Oxygen saturation \\>92% in the non-oxygenated state; 11. Women of childbearing potential who had a negative blood pregnancy test prior to the start of the trial and who agreed to use effective contraception for the duration of the trial up to the last follow-up visit; male subjects whose partners were of childbearing potential agreed to use effective contraception for the duration of the trial up to the last follow-up visit; 12. Vascular access is adequate for cell collection, and lines are available for subjects with existing central venous catheters; 13. I or my legal guardian\u002Fproxy agree to participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of brain metastases;\n2. Subjects who have previously received or are awaiting an organ transplant;\n3. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);\n4. Autoimmune diseases requiring systemic immunosuppressive therapy, such as systemic lupus erythematosus, rheumatoid arthritis, and ulcerative colitis, within 2 years prior to the start of screening;\n5. Use of any of the following medications or treatments during the designated time period prior to cell collection:\n\n   1. Surgical treatment, interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;\n   2. Subjects who have had major surgery or significant trauma within 4 weeks prior to cell collection, or who are expected to require major surgery during the study period;\n   3. Immunotherapy with anti-PD1, PD-L1, etc. within 4 weeks prior to cell collection;\n   4. Therapeutic doses of corticosteroids have been used within 3 days prior to cell collection. However, topical and inhaled steroids are permitted;\n6. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n7. Previously treated with targeted GPC3 therapy (can be enrolled if still positive for GPC3 expression upon testing);\n8. Those who have previously received other cellular therapy or genetically modified cellular therapy, such as TCR-T therapy, CAR-T therapy, etc;\n9. Prior or clinically significant CNS disorders at screening, such as epilepsy, seizures, cerebrovascular disease (ischemia\u002Fhemorrhage\u002Finfarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;\n10. Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;\n11. Subjects assessed by the investigator as having a significant amount of plasmapheresis (e.g., pleural effusion, peritoneal effusion, pericardial effusion) that cannot be controlled with treatment;\n12. Medication-uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or the presence of clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident, myocardial infarction, unstable angina pectoris, or severe cardiac arrhythmia that is uncontrolled with medication or that has a potential impact on the study treatment in the 6 months prior to the date of signing of the informed consent;\n13. Subjects who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and have a peripheral blood HBV-DNA test higher than the lower limit of detection (HBsAg-positive but with a peripheral blood HBV-DNA test lower than the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, Version 2022, at least at least 4 weeks of antiviral therapy is required prior to the first administration of the investigational drug, and during the course of the study Ongoing antiviral therapy for 6-12 months with monitoring of HBV DNA, HBsAg, and ALT levels every 1-3 months); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV-RNA test above the lower limit of detection; HIV antibody positive; syphilis antibody positive;\n14. Active EBV and cytomegalovirus, defined as subjects with IgM antibody-positive or IgM antibody-negative EBV serum but higher-than-normal EBV-DNA; and cytomegalovirus (CMV) serum IgM antibody-positive or IgM antibody-negative cytomegalovirus but higher-than-normal CMV-DNA;\n15. Abnormalities of cardiac function include: long QTc syndrome or QTc interval \\>480 ms; complete left bundle branch block, degree II\u002FIII AV block; severe, uncontrolled arrhythmia requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Appendix 3) cardiac ejection fraction less than 50% in the 6 months prior to screening; CTCAE ≥3 grade heart valve disease; myocardial infarction, cardiac angioplasty or stenting, unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening;\n16. Subjects requiring anticoagulation therapy;\n17. Subjects requiring long-term antiplatelet therapy;\n18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;\n19. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment;\n20. The presence of any factors affecting compliance with the protocol, or the unwillingness or inability of the subject to comply with the procedures required in the study protocol, as judged by the investigator.","16 Years",{"count":99,"type":21},[24],"The purpose of this study, a single-center, open, single-dose clinical study, was to evaluate the safety, tolerability, and pharmacokinetic profile of IM83 CAR-T cells in the treatment of patients with relapsed or refractory osteosarcoma",[173,174],"Refractory Osteosarcoma","Recurrent Osteosarcoma",[176,177],"IM83 CAR-T","Relapsed or refractory osteosarcoma","2024-05-10",{"date":180,"type":36},"2024-05-14",{"date":182,"type":21},"2024-06-15",{"date":184,"type":21},"2026-06-15",{"name":42,"class":43},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":44},"100396310","phase-1-assessment-of-safety-and-efficacy-of-im19-for-recurrent-or-refractory-rr-non-hodgkins-lymphomanhl-patients-100396310","NCT04440436","Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R\u002FR) Non-Hodgkin's Lymphoma(NHL) Patients","Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R\u002FR) CD19 Positive Aggressive Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.\n* CD20 positive patients undergo corresponding targeted therapy.\n* Patients must have evaluable evidence of disease (according to Lugano 2014 standards).\n* ≥ 18 years old.\n* The expected survival period is more than 3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up\n* Participate voluntarily in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* The investigators judged patients with gastrointestinal lymph nodes and\u002For central nervous system involvement who may be at risk for CAR-T treatment.\n* Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease\n* Subject has used chemotherapy or radiotherapy within three days before the blood collection period.\n* Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).\n* Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection\n* Subject has used any gene therapy products before.\n* Subject with a history of epilepsy or other central nervous system diseases.\n* Active Hepatitis B Virus or Hepatitis C Virus infections\n* The subject with other tumors in the past 5 years.\n* Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.",{"count":194,"type":21},52,[24,196],"PHASE2","This is a phase I\u002FII, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R\u002FR Non-Hodgkins Lymphoma in China.",[199],"NHL","2020-12-04",{"date":202,"type":36},"2020-12-08",{"date":204,"type":36},"2020-06-04",{"date":206,"type":21},"2035-06-04",{"name":42,"class":43},""]