[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"He Huang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":298},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,72,96,115,135,157,178,200,227,250,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578316","phase-1-human-leukocyte-antigen-hla-mismatched-unrelated-allogeneic-hematopoietic-stem-cell-transplantation-100578316",false,"NCT06809712","Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation","A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation","MIGHT","Inclusion Criteria:\n\n* Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation;\n* Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9\u002F10, or those who have difficulty finding non blood donors due to urgent medical conditions;\n* No suitable HLA matching haploidentical donor available;\n* There are suitable unrelated HLA mismatched (HLA high-resolution typing\\\u003C9\u002F10) donors;\n* The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.\n\nExclusion Criteria:\n\n* Patients with severe liver and kidney function (alanine aminotransferase\\>2.5 times the upper limit of normal, blood creatinine\\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III\u002FIV heart function, ejection fraction\\\u003C50%, severe obstructive or restrictive ventilation dysfunction);\n* Merge active infections;\n* Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points;\n* Secondary tumors with merged activity;\n* Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;\n* Combine other allo hematopoietic stem cell transplantation (HSCT) contraindications.","ALL","18 Years","60 Years",{"count":21,"type":22},29,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of \"everyone has a donor\" for allo HSCT.",[28],"Hematologic Disease",[30,31,32],"Hematopoietic cell transplantation","HLA mismatch","Hematologic diseases","RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2022-08-04",{"date":41,"type":22},"2027-10-31",{"name":43,"class":44},"He Huang","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100525317","early-phase-1-safety-and-efficacy-of-metabolically-armed-cd19-car-t-cells-meta10-19-in-the-treatment-of-rr-dlbcl-clinical-research-100525317","NCT06120166","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r\u002Fr DLBCL Clinical Research","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r\u002Fr DLBCL Clinical Research","Inclusion Criteria:\n\n* The patient or his\u002Fher guardian voluntarily signed the informed consent\n* Adult Patients clinical diagnosis of relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included)\n\nDefinition of refractory:\n\n1. No response to the last treatment, including:\n\n   The best response to the last treatment was PD, or ; The best response to the last treatment was SD and the duration was not more than 6 months after the last dose.\n2. Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including:\n\nDisease progression or recurrence within 12 months or less (recurrence must be confirmed by biopsy) after ASCT treatment, or; Patients accept remedial treatment after ASCT must have no response or relapse after the last treatment\n\n* Patients who had previously received ≥2 lines therapy including at least:\n\n  1. A chemotherapy regimen containing anthracyclines\n  2. For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL.\n* Patients with double-strike and triple-strike lymphoma who do not respond to second-line treatment, where double-strike\u002Ftriple-strike is defined as:\n\nDetection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or\u002Fand BCL-6 gene translocation by chromosome or FISH technology.\n\n* CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection)\n* At least one measurable lesion at baseline, according to the initial assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition)\n* Expected survival time greater than 12 weeks\n* The baseline ECOG score was 0 or 1\n* Organ function:\n\n  1. Kidney function is defined as:\n\n     Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m\u002F min\u002F1.73m2; \\[eGFR=186×(age)-0.203×SCr- 1. 154(mg\u002Fdl), for females, the result was ×0.742\\]\n  2. Liver function is defined as:\n\n     ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg\u002Fdl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included\n  3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n* Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%\n* Patients using the following drugs must meet the following conditions:\n\n  1. Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \\\u003C6-12mg\u002Fmm2\u002F day\n  2. Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed\n  3. Anti-proliferative therapy in addition to preconditioning chemotherapy 2 weeks prior to Meta10-19 infusion\n  4. Treatment for CNS disease must be stopped 1 week before Meta10- 19 infusion (e.g., intrathecal methotrexate)\n* The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR T cell therapy\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo\n\nExclusion Criteria:\n\n* Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* Patients with history of allogeneic hematopoietic stem cell transplantation\n* Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion\n* Patients who participated in other clinical trials within 30 days prior to enrollment\n* Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\>1000 copies\u002Fml) or hepatitis C (HCV RNA positive)\n* Patients with HIV antibody positive or treponema pallidum antibody positive\n* Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19infusion)\n* Patients with unstable angina pectoris and\u002For myocardial infarction within 6 months prior to enrollment\n* Patients with history of other malignancies, but the following conditions can be enrollment:\n\n  1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);\n  2. Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent\n  3. The primary malignancy has been completely resected and in complete remission for ≥5 years\n* Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive)\n* Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);\n* Other conditions that the investigator considered should not be enrolled in this clinical study, such as poor compliance.",{"count":54,"type":22},18,[56],"EARLY_PHASE1","A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Diffuse Large B-Cell Lymphoma",[59],"Diffuse Large B-cell Lymphoma",[61,62,63],"Meta10-19","CAR-T Cells Therapy","r\u002Fr DLBCL","2025-09-15",{"date":66,"type":37},"2025-09-19",{"date":68,"type":37},"2023-11-16",{"date":70,"type":22},"2026-04-05",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":45},"100585412","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-leukemia-100585412","NCT06902025","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia","An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n1. Age 18\\~75 years old, gender is not limited;\n2. Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n3. Meet the diagnosis of relapsed\u002Frefractory (relapsed\u002Frefractory) r\u002Fr CD19+ B-ALL, including any of the following:\n\n   A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy;\n\n   C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:\n\n   ① Relapse or refractory after treatment with at least two tyrosine kinase inhibitor (TKI) agents or intolerance to TKI-type agents;\n\n   ② Resistance or failure to achieve remission after receiving second-line TKI therapy;\n\n   ③ Not suitable for TKI therapy;\n4. Bone marrow cytomorphology with \\>5% prolymphocytes + juvenile lymphocytes; or flow Minimal Residual Disease(MRD) \\>=0.01%\n5. Serum total bilirubin ≤ 51 mol\u002FL, serum alanine aminotransferase (ALT) and azelaic transaminase (AST) both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol\u002FL, and platelets ≥ 20×109\u002FL;\n6. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;\n7. Subjects without active pulmonary infection and inspiratory finger pulse oxygen saturation ≥92%;\n8. Subjects have not received radiotherapy, chemotherapy, monotherapy or other anti-ALL therapy within 1 week prior to screening;\n9. Predicted survival of 3 months or more;\n10. Eastern Cooperative Oncology Group(ECOG) score of 0-2;\n11. Subjects or their legal guardians volunteered to participate in this study and signed an informed consent form;\n\nExclusion Criteria:\n\n1. Subjects with active central nervous system (CNS) leukemia;\n2. Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n3. Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;\n4. Subjects who have had radiation therapy within 2 weeks prior to infusion;\n5. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);\n6. Subjects with unstable angina and\u002For myocardial infarction within 6 months prior to Screening;\n7. Subjects with other prior or concurrent malignancies, with the following exceptions:\n\n   ① Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);\n\n   ② Cancer in situ of the cervix or breast that has been curatively treated and shows no signs of recurrence for at least 3 years prior to study entry;\n\n   ③ primary malignancy that has been completely resected and in complete remission for ≥ 5 years.\n8. Presence of subjects with arrhythmias not controlled by medical management;\n9. Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n10. Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;\n11. Subjects who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the investigational procedures or have other medical conditions that may place them at unacceptable risk.\n12. Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.","75 Years",{"count":81,"type":22},24,[83],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).",[86],"B-ALL","NOT_YET_RECRUITING","2025-03-24",{"date":90,"type":37},"2025-03-30",{"date":92,"type":22},"2025-03-31",{"date":94,"type":22},"2027-12-31",{"name":43,"class":44},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":114,"locationsCount":4},"100584334","jy231jy231-injection-for-the-treatment-of-refractory-autoimmune-diseases-ads-100584334","NCT06887985","JY231(JY231) Injection for the Treatment of Refractory Autoimmune Diseases (ADs)","An Early Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs)","Inclusion Criteria:\n\n1. Age: 18\\~75 years old, male or female, signed informed consent (ICF);\n2. Diagnosis of one of the following diseases:\n\n   1. Systemic Lupus Erythematosus (SLE), European League Against Rheumatism\u002F (EULAR)\u002FAmerican College of Rheumatology(ACR) 2019 criteria), and Antinuclear Antibodies(ANA) \\> 1:80 or ds-DNA positive;\n   2. Dry syndrome (SS), 2016 ACR\u002FEULAR criteria and at least Sjögren's Syndrome Antigen A(SSA) positive;\n   3. Systemic sclerosis (SSc), 2013 ACR\u002FEULAR criteria and ANA \\> 1:80 or anti-Scleroderma(SCL)-70 positive;\n   4. Dermatomyositis (DM), 2017 EULAR\u002FACR classification criteria and positive for any of the myositis-specific antibodies (Jo-1), Zo, Anti-Glycyl-Transfer Ribonucleic Acid(tRNA) Synthetase Antibody(EJ), Anti - Threonyl - tRNA Synthetase Antibody(PL-7), Anti-Aspartyl-tRNA Synthetase Antibody(KS), Anti-isoleucyl-tRNA Synthetase Antibody(OJ), PL-12, Anti-Tyrosyl-tRNA Synthetase Antibody(YRS), Anti-nuclear matrix protein(NXP)-2, Anti - transcription intermediary factor 1 gamma Antibody(Anti-TIF1g), Anti-Mi-2, Anti-small ubiquitin - like modifier - activating enzyme Antibody(Anti-SAE), Anti-MDA-5, Anti-signal recognition particle Antibody(Anti-SRP), Anti-HMGCR);\n   5. Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA-AAV), including granulomatous polyangiitis (GPA), or microscopic vasculitis (MPA), or eosinophilic granulomatous polyangiitis (EGPA),2022 ACR\u002FEULAR criteria, and ANCA antibody-positive, including c-ANCA\u002Fp-ANCA\u002Fanti Proteinase 3(PR3)\u002Fanti-Myeloperoxidase(MPO) positive.\n3. Patients who have been treated with ≥2 immunosuppressive agents for 6 months, or who are intolerant to standard therapy, or who have relative contraindications, and whose disease activity meets the following criteria:\n\n   1. For SLE patients, SLEDAI≥ 8 points;\n   2. For SS patients, European League Against Rheumatism Sjögren's Syndrome Disease Activity Index(ESSDAI) ≥ 14 points;\n   3. For SSc patients with an Modified Rodnan Skin Score(mRSS) score between 10-35 (inclusive of the cutoff), combined with interstitial lung disease (ILD);\n   4. For DM patients, 1 year after diagnosis, and the following conditions are met:\n\n      ① Rash VAS score (based on MDAAT) ≥ 3 cm and at least 3 CSM abnormalities;\n\n      ②Muscle biopsy pathology or muscle nuclear magnetic resonance suggestive of active inflammation;\n\n      ③ Bilateral Manual Muscle Testing (MMT-8) \\\u003C 125\u002F150 and at least 2 additional Core set measures (CSM) meeting the criteria specified below: a. Patient scores on a 10 cm Visual Analog Scale (VAS) with a minimum of 2.0 cm; b. Physician scores on a 10 cm VAS with a minimum of 2.0 cm; c. Health Assessment Questionnaire (HAQ) Disability Index with a minimum value of 0.25; d. Elevation of at least one muscle enzyme (including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)), with a minimum level of 1.3 x the upper limit of normal; and e. Extramuscular Organ Disease Activity Score with a minimum level of 1.3 x the upper limit of normal on a 10 cm VAS scale. minimum of 1.0 cm on a 10 cm VAS scale (This VAS is a physician's comprehensive assessment based on the Myositis Disease Activity Assessment Tool (MDAAT) which evaluates activity scores on the General Condition, Skin, Skeletal, Gastrointestinal, Lung, and Cardiac scales);\n   5. For ANCA-AAV patients, British Vasculitis Activity Score(BVAS) score ≥15,and ANCA antibody.\n4. Eastern Cooperative Oncology Group (ECOG) 0 to 1 point;\n5. Critical organ function assessment meets the following conditions:\n\n   1. Blood: hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL;\n   2. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, ECG without obvious abnormalities;\n   3. Renal function: Estimated Glomerular Filtration Rate(eGFR) ≥30 mL\u002Fmin\u002F1.73m2;\n   4. Liver function: AST and ALT ≤ 3.0 upper limit of normal(ULN) and total bilirubin ≤ 2.0 ULN;\n   5. Have criteria for single or venous blood collection and no other contraindications to cell collection;\n6. Subjects of childbearing age with negative urine pregnancy test results and agree to use effective contraception during the study until 1 year post-infusion;\n7. The patient or his\u002Fher guardian agrees to participate in the study and signs an informed consent form, indicating that he\u002Fshe understands the purpose and procedures of the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Have received prior CAR-T cell therapy;\n2. Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system disorders that, in the judgment of the investigator, outweigh the risks of participation in the study;\n3. Active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;\n4. Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B virus (HBV) DNA titer test is greater than the normal reference range; or Hepatitis C virus (HCV) antibody positive and peripheral blood Hepatitis C virus (HCV) RNA titer test is greater than the normal reference range; or Human Immunodeficiency Virus (HIV) antibody positive; or positive syphilis test; or positive cytomegalovirus (CMV) DNA test;\n5. Have received a live vaccine within 4 weeks prior to screening;\n6. Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;\n7. Patients with malignant diseases such as malignant tumors prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n8. Patients who have participated in another clinical study within 3 months prior to screening;\n9. Other conditions that the investigator considers unsuitable for participation in the study.",{"count":104,"type":22},45,[83],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with Refractory Autoimmune Diseases (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune Diseases (ADs).",[108],"Autoimmune Diseases","2025-03-19",{"date":111,"type":37},"2025-03-21",{"date":92,"type":22},{"date":94,"type":22},{"name":43,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":45},"100583680","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-lymphoma-100583680","NCT06879470","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Lymphoma","An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Subjects voluntarily signed an informed consent form and were willing and able to comply with all study requirements;\n2. Age 18\\~75 years old, gender is not limited;\n3. Malignant tumor cells positive for Cluster of Differentiation 19(CD19);\n4. Meet the criteria for relapsed or refractory B-cell lymphoma. Relapsed: the subject's tumor reappears after achieving complete remission of the disease; refractory: the subject is ineffective or in only partial remission on standard treatment regimens. Subjects must have relapsed or become refractory after receiving at least two lines of systemic therapy or autologous hematopoietic stem cell transplantation.\n5. The presence of at least one measurable lesion on imaging of relapsed or refractory B-cell lymphoma, i.e., a lymph node lesion \\>15 mm in length or an extranodal lesion \\>10 mm in length based on CT cross-sectional images, along with a positive Fluorodeoxyglucose Computed Tomography(FDG-PET).\n6. Expected survival ≥12 weeks;\n7. Eastern Cooperative Oncology Group(ECOG) score of 0 to 1 at baseline;\n8. Good organ function (the standard can be appropriately relaxed for indicators involving liver and kidney function)\n\n   1. Albuminous aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN);\n   2. Albumin transaminase (AST) ≤ 3 times the ULN;\n   3. Total bilirubin ≤ 1.5 times the ULN;\n   4. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL\u002Fmin;\n   5. Room oxygen saturation ≥92% without oxygen;\n   6. left ventricular ejection fraction (LVEF) ≥50%;\n9. Men of childbearing potential to ensure effective contraception for sexual partners; women of childbearing potential to use effective contraception and agree to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active central nervous system (CNS) lymphoma;\n2. Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n3. Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;\n4. Subjects who have had radiation therapy within 2 weeks prior to infusion;\n5. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);\n6. Subjects with unstable angina and\u002For myocardial infarction within 6 months prior to Screening;\n7. Subjects with other prior or concurrent malignancies, with the following exceptions:\n\n   1. Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);\n   2. Carcinoma in situ of the cervix or breast, curatively treated, with no sign of recurrence for at least 3 years prior to study entry;\n   3. Primary malignant tumor that has been completely resected and in complete remission for ≥ 5 years.\n8. Presence of subjects with arrhythmias not controlled by medical management;\n9. Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n10. Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;\n11. Subjects who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the study procedures or have other medical conditions that may place them at unacceptable risk.\n12. Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.",{"count":81,"type":22},[83],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma.",[126],"B-Non Hodgkin Lymphoma","2025-03-11",{"date":129,"type":37},"2025-03-17",{"date":131,"type":22},"2025-03",{"date":133,"type":22},"2027-12",{"name":43,"class":44},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":45},"100528558","a-study-of-the-safety-and-preliminary-efficacy-of-ly-m001-injection-in-the-treatment-of-adult-patients-with-gaucher-disease-type-i-100528558","NCT06162338","A Study of the Safety and Preliminary Efficacy of LY-M001 Injection in the Treatment of Adult Patients With Gaucher Disease Type I","A Prospective, Single-center, Open-arm, Single-arm Study of the Safety and Preliminary Efficacy of Single Intravenous Infusion Administration of LY-M001 Injection in the Treatment of Adult Patients With Gaucher Disease Type I","LY-M001","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 60 years, male or female.\n2. The subjects should fully understand the purpose, nature and method of this study as well as possible adverse reactions, and sign the informed consent form (ICF) voluntarily.\n3. Patients with GD1 who have confirmed double mutations in the Gba1 allele by laboratory testing and meet the standard for clinical diagnosis of Gaucher disease (i.e., reduced GCase enzyme activity to less than 30% of normal values).\n4. The subjects were type I patients with Gaucher disease. Patients with type I Gaucher disease who had received specific treatment in the past required 5 half-lives of elution\n5. Negative pregnancy test for female subjects of childbearing potential 6.6.The subject and his\u002Fher partner have no plans to have children during the screening period and within 6 months after the end of the study, and voluntarily take effective contraceptive measures (such as abstinence, condom, etc.); and the subject had no plans to donate sperm or eggs.\n\n7.Subjects are not to donate blood during the study and for at least 1 year after the end of the study.\n\nExclusion Criteria:\n\n1. AAV8 neutralizing antibody is strongly positive.\n2. Patients with clinically suspected Gaucher disease type II (GD2) or Gaucher disease type III (GD3).\n3. Active and progressive bone disease that is expected to require surgical treatment within the next 6 months.\n4. Subject has idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), thrombocytopenia, anemia, hepatomegaly, splenomegaly, and\u002For osteoporosis unrelated to Gaucher disease as judged by the investigator.\n5. Treatment or disposition of an investigational drug or investigational device for another clinical investigation within 28 days or 5 half-lives (only for drugs), whichever is longer, prior to Screening.\n6. Evidence of clinically significant liver disease, fragile liver, or history of hepatotoxin exposure, meeting at screening, but not limited to, any of the following:\n\n   * Progressive hepatomegaly and greater than 3 times normal volume.\n   * History of stage 2 or greater liver fibrosis.\n   * AST, ALT or TBIL greater than 1.5 times the upper limit of normal (ULN).\n   * History of alcohol or drug abuse within the previous 2 years.\n   * Hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus DNA positive (HBV-DNA \\> 103 copies\u002FmL); or taking hepatitis B virus drugs (such as interferon, lamivudine, adefovir and entecavir); or hepatitis C virus (HCV) antibody positive.\n7. Human immunodeficiency virus (HIV) antibody positive or Treponema pallidum antibody positive.\n8. Severe hyperlipidemia (triglycerides \\> 1000 mg\u002FdL).\n9. Uncontrolled concomitant disease or infectious disease (need to be judged by the investigator based on clinical practice).\n10. Subject had undergone splenectomy and were scheduled to undergo splenectomy during the study period.\n11. Karnofsky score (KPS) \\\u003C 70.\n12. The subject has received or plans to receive bone marrow transplantation, hematopoietic stem cell transplantation and\u002For major organ transplantation, including but not limited to liver transplantation, kidney transplantation, etc.\n13. Subject has received erythropoietin, transfusion, or red blood cell transfusion within 3 months prior to screening ;or platelet transfusion within 1 month prior to screening.\n14. Clinically diagnosed or significant cardiovascular disease as judged by the investigator (e.g., New York Heart Association \\[NYHA\\] class ≥ 3 heart failure).\n15. Hypersensitivity to any component of LY-M001 Injection.\n16. Previous treatment with any type of gene therapy or cell therapy.\n17. Use of systemic immunosuppressive agents or steroid therapy other than those required by the protocol for prophylactic administration within 3 months prior to dosing.\n18. History of cancer within 5 years of screening, except for completely resected non-melanoma skin cancer, non-metastatic prostate cancer, and completely treated ductal carcinoma in situ.\n19. Has received a live attenuated vaccine within 4 months prior to screening or plans to receive a live attenuated vaccine during the clinical trial.\n20. Other conditions that, in the opinion of the investigator, make the subject unsuitable for the study.",{"count":144,"type":22},3,[83],"This is a prospective single-center, open, single-arm, single-dose intravenous infusion study to evaluate the safety and initial efficacy, pharmacodynamic characteristics, immunogenicity, biodistribution, and viral shedding of LY-M001 injection.This study mainly includes the main study stage and the long-term follow-up study stage.",[148],"Gaucher Disease Type I","2025-02-11",{"date":151,"type":37},"2025-02-14",{"date":153,"type":37},"2023-11-15",{"date":155,"type":22},"2031-12-17",{"name":43,"class":44},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":177,"locationsCount":45},"100578315","phase-1-human-leukocyte-antigen-hla-mismatched-related-allogeneic-hematopoietic-stem-cell-transplantation-100578315","NCT06809699","Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation","A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation","HIGHT","Inclusion Criteria:\n\n* Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation with no available related human leukocyte antigen (HLA) identical sibling donors;\n* No available donor with HLA high-resolution typing ≥ 9\u002F10 or those who have difficulty finding donors due to urgent medical conditions;\n* No suitable HLA matching haploidentical donor available;\n* There is a suitable donor with mismatched HLA typing;\n* The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.\n\nExclusion Criteria:\n\n* Patients with severe liver and kidney function (alanine aminotransferase\\>2.5 times the upper limit of normal, blood creatinine\\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III\u002FIV heart function, ejection fraction\\\u003C50%, severe obstructive or restrictive ventilation dysfunction);\n* Merge active infections;\n* Eastern Cooperative Oncology Group (ECOG) score ≥ 2 points;\n* Secondary tumors with merged activity;\n* Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;\n* Combine other allo HSCT contraindications.",{"count":21,"type":22},[25],"This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of \"everyone has a donor\".",[169],"Hematologic Diseases",[30,171,32],"HLA mismatch related","2025-01-30",{"date":174,"type":37},"2025-02-05",{"date":39,"type":37},{"date":41,"type":22},{"name":43,"class":44},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":45},"100576455","early-phase-1-cd19bcma-car-t-cell-therapy-for-refractoryrelapsed-lupus-nephritis-100576455","NCT06785519","CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis","A Clinical Study of the Safety and Efficacy of CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old;\n* 2\\. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) \u002FACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN\u002FRPS standard.\n* 3\\. SLEDAI-2K ≥8 during screening\n* 4\\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);\n* 5\\. Expected survival \\>12 weeks;\n* 6\\. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);\n* 7\\. Volunteer to participate in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Active infected persons who are not cured:\n* 4\\. Active hepatitis B or C virus infection;\n* 5\\. Patients who have taken more than 20mg\u002Fd of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);\n* 6\\. Have used any gene therapy products before;\n* 7\\. Insufficient amplification ability (\\\u003C5 times) in response to CD3 \u002F CD28 costimulation signals;\n* 8\\. ALT\u002FAST\\>3 times the normal amount or bilirubin \\>2.0 mg\u002Fdl;\n* 9\\. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;\n* 10\\. HIV-infected people;\n* 11\\. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.",{"count":186,"type":22},9,[56],"A Clinical Study of the Safety and Efficacy of CD19\u002FBCMA CAR-T Cell Therapy for Refractory\u002FRelapsed Lupus Nephritis.",[190],"Lupus Nephritis",[192],"CD19\u002FBCMA CAR-T","2025-01-20",{"date":195,"type":37},"2025-01-21",{"date":197,"type":22},"2025-01-31",{"date":41,"type":22},{"name":43,"class":44},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":79,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":45},"100560029","phase-4-ric-allo-hsct-vs-venetoclax-based-consolidation-in-elderly-aml-patients-after-first-cr-100560029","NCT06571825","RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR","Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation in Comparison to Consolidation Therapy Based Venetoclax for Elderly Patients With Acute Myeloid Leukemia After First CR","Inclusion Criteria:\n\n* Diagnosed with AML according to the 2022 WHO diagnostic criteria;\n* Age 60-75 years;\n* Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\\^9\u002FL);\n* Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy;\n* Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN;\n* Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \\> 8 weeks;\n* Voluntarily signed the informed consent form and can understand and comply with the study's requirements.\n\nExclusion Criteria:\n\n* Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening;\n* Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);\n* Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication;\n* Pregnant or breastfeeding women;\n* Unable to understand, comply with the study protocol, or unable to sign the informed consent form.",{"count":208,"type":22},118,[210],"PHASE4","Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).",[213],"Acute Myeloid Leukemia",[215,216,217,218],"elderly","AML","venetoclax","allo-HSCT","2024-08-22",{"date":221,"type":37},"2024-08-26",{"date":223,"type":37},"2024-07-17",{"date":225,"type":22},"2028-02-28",{"name":43,"class":44},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":45},"100522618","phase-1-a-study-of-deeptag-gprc5d-targeted-car-t-cells-therapy-for-refractoryrelapsed-multiple-myeloma-100522618","NCT06084962","A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n* 1\\. Those who voluntarily participated in this trial and provided informed consent;\n* 2\\. Gender unlimited，18\\\u003CAge≤75;\n* 3\\. Estimated life expectancy of minimum of 12 weeks;\n* 4\\. ECOG 0-2;\n* 5\\. Diagnosed as multiple myeloma according to the IMWG criteria;\n* 6\\. Subjects failed treatment with at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors (PIs) ，immunomodulatory agents (IMiDs) and CD38 antibody）, or recived the above three treatment methods experienced disease progression or recurrence during the most recent treatment process or within 6 months after the end of treatment, Difficulty in treatment includes primary difficulty in treatment ( patient has not achieved minimal remission or disease progression during treatment) or secondary difficulty in treatment (patient develops disease progression within 60 days after completion of treatment);\n* 7\\. Women have a negative urine pregnancy test before the start of medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up;\n* 8\\. The blood routine meets the following standards:\n\n  1. Lymphocyte count\\>0.3×10e9\u002FL;\n  2. Neutrophils ≥0.5×10e9\u002FL;\n  3. Hemoglobin ≥60g\u002FL;\n  4. Platelet ≥30×10e9\u002FL\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Pregnant (or lactating) women;\n* 4\\. Patients with HIV infection;\n* 5\\. Active infection of hepatitis B virus or hepatitis C virus;\n* 6\\. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;\n* 7\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 8\\. Creatinine\\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n* 9\\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;\n* 10\\. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;\n* 11\\. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;\n* 12\\. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;\n* 13\\. Patients received allogeneic stem cell therapy;\n* 14\\. Any unsuitable to participate in this trial judged by the investigator.",{"count":234,"type":22},40,[25],"Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory\u002Frelapsed multiple myeloma",[238],"Relapse\u002FRefractory Multiple Myeloma",[240,241],"Multiple Myeloma","DeepTag-GPRC5D CAR T-cell","2023-10-10",{"date":244,"type":37},"2023-10-16",{"date":246,"type":22},"2023-10-20",{"date":248,"type":22},"2026-10-20",{"name":43,"class":44},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":45},"100379933","early-phase-1-a-study-of-cta101-ucar-t-cell-injection-in-patients-with-relapsed-or-refractory-cd19-b-line-hematological-malignancy-100379933","NCT04227015","A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy","Inclusion Criteria:\n\nInclusion criteria applicable to ALL only:\n\n1. Male or female aged ≥ 3 and \\\u003C70 years old;\n2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n   1. CR not achieved after standardized chemotherapy;\n   2. CR achieved following the first induction, but CR duration is ≤ 12 months;\n   3. Ineffective after first or multiple remedial treatments;\n   4. 2 or more recurrences;\n4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (morphology) and\u002For \\>1% (Flow cytometry);\n5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n\nInclusion criteria applicable to NHL only:\n\n1. Male or female aged ≥ 18 and \\\u003C70 years old;\n2. Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia\u002Fsmall lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma;\n3. Relapsed or refractory DLBCL (meeting one of the following conditions):\n\n   1. No remission or recurrence after receiving second-line or above second-line chemotherapy;\n   2. Primary drug resistance;\n   3. Recurrence after autologous hematopoietic stem cell transplantation\n4. According to Lugano 2014, there should be at least one evaluable tumor lesion.\n\nApplicable standards for ALL and NHL:\n\n1. HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-);\n2. total bilirubin ≤ 51umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol\u002FL;\n3. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n4. No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%;\n5. Estimated survival time ≥ 3 months;\n6. ECOG performance status 0 to 2;\n7. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);\n2. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia\u002Flymphoma per WHO Classification Criteria (for ALL patients only);\n3. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);\n4. patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and\u002For intracranial lymphoma invasion shown by MRI) (for NHL patients only) ;\n5. extensive involvement of gastrointestinal lymphoma (for NHL patients only);\n6. radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;\n7. Have a history of allergy to any of the components in the cell products;\n8. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;\n9. According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;\n10. Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;\n11. Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);\n12. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n13. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n14. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).\n15. Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural\u002Fperitoneal\u002Fpericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;\n16. History of other primary cancer, except for the following conditions:\n\n    1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin;\n    2. Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;\n17. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;\n18. Patients with graft-versus-host disease (GVHD);\n19. Prior immunizations with live vaccine 4 weeks prior to screening;\n20. History of alcoholism, drug abuse or mental illness;\n21. If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B \\> 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection;\n22. Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;\n23. Patients who have participated in any other clinical studies within 2 weeks prior to screening;\n24. pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender);\n25. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","3 Years","70 Years",{"count":259,"type":22},72,[56],"A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy",[263,264],"Acute Lymphoblastic Leukemia","Non-hodgkin Lymphoma","2020-12-24",{"date":267,"type":37},"2020-12-28",{"date":269,"type":37},"2020-01-08",{"date":271,"type":22},"2027-05-31",{"name":43,"class":44},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":257,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":45},"100384232","early-phase-1-a-study-of-cd20cd22-targeted-car-t-cell-therapy-for-relapsed-or-refractory-lymphoid-malignancies-100384232","NCT04283006","A Study of CD20\u002FCD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies","Criteria:\n\nInclusion Criteria:\n\nInclusion criteria applicable to ALL only:\n\n1. Male or female aged ≥ 3 and \\\u003C70 years old;\n2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n   1. CR not achieved after standardized chemotherapy;\n   2. CR achieved following the first induction, but CR duration is ≤ 12 months;\n   3. Ineffective after first or multiple remedial treatments;\n   4. 2 or more recurrences;\n4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (morphology) and\u002For \\>1% (Flow cytometry);\n5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome- positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n\nInclusion criteria applicable to NHL only:\n\n1. Male or female aged ≥ 18 and \\\u003C70 years old;\n2. Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia\u002Fsmall lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma;\n3. Relapsed or refractory DLBCL (meeting one of the following conditions):\n\n   1. No remission or recurrence after receiving second-line or above second-line chemotherapy;\n   2. Primary drug resistance;\n   3. Recurrence after autologous hematopoietic stem cell transplantation;\n4. According to Lugano 2014, there should be at least one evaluable tumor lesion.\n\nApplicable standards for ALL and NHL:\n\n1. HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-);\n2. total bilirubin ≤ 51umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol\u002FL;\n3. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n4. No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%;\n5. Estimated survival time ≥ 3 months;\n6. ECOG performance status 0 to 2;\n7. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);\n2. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia\u002Flymphoma per WHO Classification Criteria (for ALL patients only);\n3. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);\n4. Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and\u002For intracranial lymphoma invasion shown by MRI) (for NHL patients only) ;\n5. Extensive involvement of gastrointestinal lymphoma (for NHL patients only);\n6. Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;\n7. Have a history of allergy to any of the components in the cell products;\n8. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;\n9. According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;\n10. Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;\n11. Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);\n12. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n13. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n14. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).\n15. Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural\u002Fperitoneal\u002Fpericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;\n16. History of other primary cancer, except for the following conditions:\n\n    1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin;\n    2. Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;\n17. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;\n18. Patients with graft-versus-host disease (GVHD);\n19. Prior immunizations with live vaccine 4 weeks prior to screening;\n20. History of alcoholism, drug abuse or mental illness;\n21. If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B \\> 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection;\n22. Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;\n23. Patients who have participated in any other clinical studies within 2 weeks prior to screening;\n24. Pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender);\n25. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.",{"count":280,"type":22},100,[56],"A Study of CD20\u002FCD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.",[284,285],"Relapsed and Refractory","Lymphoid Hematological Malignancies",[287,288,289],"lymphoid hematological malignancies","CAR T-cell therapy","CD20\u002FCD22","2020-08-20",{"date":292,"type":37},"2020-08-21",{"date":294,"type":37},"2018-05-23",{"date":296,"type":22},"2028-05-23",{"name":43,"class":44},""]