[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Hematology & Blood Diseases Hospital, China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":576},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,239,0,25,[9,47,75,97,126,150,173,194,215,236,257,283,305,327,351,370,390,408,432,451,475,494,514,534,552],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100639463","phase-2-cm336-plus-isatuximab-for-newly-diagnosed-multiple-myeloma-with-renal-impairment-100639463",false,"NCT07585760","CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Renal Impairment","A Prospective, Single-arm, Single-center, Phase II Study of BCMA\u002FCD3 Bispecific Antibody Combined With CD38 Monoclonal Antibody in Newly Diagnosed Multiple Myeloma Patients With Renal Impairment","CAREMM-012","Inclusion Criteria:\n\n1. Age 18 to 80 years.\n2. Newly diagnosed symptomatic multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) criteria. Patients who have received up to 1 cycle of prior anti-myeloma therapy, excluding immunotherapeutic agents, are allowed to enroll.\n3. Presence of measurable disease at diagnosis, meeting at least one of the following criteria:\n\n   A.Serum M-protein ≥ 1 g\u002FdL (\\> 10 g\u002FL) measured by serum protein electrophoresis (SPEP) (for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead); OR\n\n   B.Urine M-protein ≥ 200 mg\u002F24 hours; OR\n\n   C.If both serum and urine M-protein do not meet the above criteria, an abnormal serum free light chain (FLC) ratio (normal FLC ratio: 0.26 to 1.65) with an involved serum FLC level ≥ 100 mg\u002FL.\n4. Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin (calculated using the Modification of Diet in Renal Disease \\[MDRD\\] formula). The type of renal impairment must be restricted to cast nephropathy, which can be confirmed by renal biopsy or by the investigator's clinical judgment based on light chain proteinuria. If urine albumin accounts for more than 30% of the total urine protein, a renal biopsy is mandatory to confirm cast nephropathy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.\n6. Adequate major organ function, meeting the following criteria:\n\n   A. Hematological function:\n   1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL, and without receiving granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, or pegylated G-CSF within 14 days prior to testing;\n   2. Hemoglobin ≥ 60 g\u002FL, and without receiving whole blood or red blood cell transfusions within 7 days prior to testing;\n   3. Platelet count ≥ 50 × 10\\^9\u002FL, and without receiving whole blood, platelet transfusions, or thrombopoietin receptor agonists (TPO-RAs) within 7 days prior to testing.\n\n   B. Hepatic function:\n\n   Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 × ULN, and total bilirubin ≤ 2 × ULN (subjects with a history of Gilbert's syndrome are eligible if direct bilirubin ≤ 2.0 × ULN).\n\n   C. Coagulation function:\n7. International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n8. No active concomitant malignancies or malignancies with an expected survival of less than 12 months.\n9. Willingness to participate in the study, good compliance, and ability to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis, or secondary plasma cell leukemia.\n2. Central nervous system (CNS) involvement or clinical evidence of meningeal involvement.\n3. Severe and\u002For uncontrolled cardiac diseases, including: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe and uncontrolled arrhythmias; or other cardiovascular\u002Fcerebrovascular diseases deemed unsuitable for study participation by the investigator.\n4. Presence of active infections, including: HIV positive; active Hepatitis B (HBV-DNA positive); active Hepatitis C (HCV-RNA positive); active or latent syphilis infection (Treponema pallidum antibody positive); active tuberculosis (active TB infection indicated by chest imaging or other relevant tests within the past 3 months or during the screening period); or other active infections deemed unsuitable for study participation by the investigator.\n5. Patients with concurrent malignancies; or severe concomitant diseases that, in the investigator's judgment, would severely compromise patient safety or interfere with study completion.\n6. Pregnant or lactating women.\n7. History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to any components of the study drugs.\n8. Unable or unwilling to sign the informed consent form.\n9. Any other conditions that, in the opinion of the investigator, make the patient unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":22,"type":23},26,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by renal impairment (\\[eGFR\\] \\\u003C 40 mL\u002Fmin). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.",[29,30],"Multiple Myeloma (MM)","Multiple Myeloma Light Chain Induced Renal Insufficiency",[32,33],"BCMA\u002FCD3 bispecific antibody","CM336","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":23},"2026-07-25",{"date":42,"type":23},"2028-12-30",{"name":44,"class":45},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100629605","rhtpo-dose-escalation-vs-eltrombopag-switch-in-itp-100629605","NCT07476846","rhTPO Dose Escalation vs Eltrombopag Switch in ITP","Drug Switching Strategy Study After rhTPO Second-Line Treatment Failure in ITP: A Randomized Controlled Trial Comparing High-Dose rhTPO Versus Eltrombopag","Inclusion Criteria:\n\n1. Age 12-75 years, either sex;\n2. ECOG performance status 0-1;\n3. Diagnosis of ITP confirmed by bone marrow biopsy (valid within 3 months) or other relevant examinations;\n4. Patients who failed short-term rhTPO second-line treatment (≤14 days of medication) (PLT \\\u003C 30×10⁹\u002FL);\n5. Major organ function must meet the following requirements (based on normal values at the clinical trial center):\n\n   1. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; no abnormalities other than ITP, except: a) PLT \\\u003C 30×10⁹\u002FL at Day 1 visit or within 48 hours of Day 1 is acceptable for enrollment; b) Hemoglobin: if anemia is clearly due to ITP (excessive bleeding related to thrombocytopenia), subjects with hemoglobin below the lower limit of normal may be enrolled based on investigator judgment;\n   2. Blood biochemistry: total bilirubin (TBIL) ≤ 1.5×ULN; ALT, AST, or ALP ≤ 3×ULN; serum creatinine (Cr) ≤ 1.5×ULN with creatinine clearance ≥ 50 mL\u002Fmin;\n   3. Coagulation function: prothrombin time (PT) within ±3s of normal range; activated partial thromboplastin time (APTT) ≤ 1.5×ULN unless on medications known to alter INR and APTT; no history of coagulation abnormalities other than ITP;\n6. Previous ITP combination treatments including platelet transfusion, immunoglobulin, immunomodulators, and cyclophosphamide rescue therapy must have ended ≥2 weeks before enrollment; corticosteroids or TPO-class drug treatments must have ended ≥2 weeks before study start;\n7. Patients on immunosuppressants (including corticosteroids, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) or platelet-elevating traditional Chinese medicine maintenance therapy must have stable therapeutic doses for at least the most recent month; patients receiving CD20 monoclonal antibody must have stopped treatment ≥6 months before enrollment; splenectomy patients may enroll ≥6 months after surgery;\n8. Women of childbearing potential must have negative serum pregnancy test within 24 hours before first dose; all subjects must agree to use effective contraception during the study and for 6 months after study treatment completion;\n9. No contraindications to rhTPO and eltrombopag use;\n10. Voluntary participation in this study, signed informed consent, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Refractory ITP patients (failure of first-line and second-line thrombopoietic drugs and CD20 monoclonal antibody treatment, or splenectomy failure\u002Fpostoperative relapse);\n2. Pregnant or lactating patients;\n3. Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis) or drug-induced (e.g., anticonvulsants, antibiotics, heparin), or bicytopenia\u002Fpancytopenia such as Evans syndrome, immune-related cytopenias, etc.;\n4. History or current presence of primary diseases other than ITP causing thrombocytopenia (e.g., primary myelodysplastic syndrome \\[MDS\\], congenital bone marrow failure diseases \\[e.g., Fanconi anemia, dyskeratosis congenita\\], aplastic anemia \\[AA\\]), and judged by investigator as unsuitable for this study;\n5. History of intracranial hemorrhage or other important organ severe bleeding (\\>CTC AE Grade 3), or history of symptomatic gastrointestinal bleeding (e.g., hematemesis, melena) within 6 months before screening (occult blood test positivity without symptoms\u002Fsigns and hemorrhoids excluded);\n6. History of any arterial or venous thrombosis within 6 months before enrollment (including stroke, TIA, MI, DVT, or PE) AND presence of at least 2 of the following risk factors: hormone replacement therapy, oral contraceptives (including estrogen), smoking, diabetes, hypercholesterolemia, drug-controlled hypertension, hereditary coagulation disorders;\n7. Severe cardiovascular disease within 6 months before enrollment (NYHA Class III-IV), known arrhythmia increasing thromboembolic risk such as atrial fibrillation, coronary stent implantation, angioplasty, or post-CABG patients;\n8. Coexisting malignancy severely affecting survival;\n9. Continuous use of medications affecting platelet function (including but not limited to aspirin, clopidogrel, and\u002For NSAIDs) or anticoagulant therapy \\>3 days from 2 weeks after study start until study end;\n10. Use of any herbal medicine or nutritional supplements within 1 week before study start, except vitamin and mineral supplements;\n11. Currently having severe or uncontrolled infection (CTC AE Grade 2 infection);\n12. Laboratory or clinical evidence of HIV infection, previous hepatitis C clinical history, previous hepatitis B infection, or active hepatitis\u002Factive tuberculosis at screening. Screening laboratory tests indicating hepatitis C or hepatitis B infection (defined as positive HBsAg; additionally, if HBsAg negative but HBcAb positive, regardless of HBsAb status, HBV DNA testing is required, and if positive, subject should be excluded);\n13. Patients considered by investigator as unsuitable for this trial due to any other medical, social, or psychological factors that may affect safety or compliance with study procedures.","12 Years","75 Years",{"count":57,"type":23},112,[59],"NA","This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU\u002Fkg\u002Fd) after 14 days of treatment (PLT \\\u003C 30×10⁹\u002FL). After a 2-week washout period, they will be randomized to the rhTPO double-dose group (Group A) and EPAG-pfos group (Group B), with blood routine monitored weekly and doses adjusted according to platelet levels, comparing the response rates of the two groups at 6 weeks after switching treatment.",[62],"Primary Immune Thrombocytopenia (ITP)",[64,65,66],"ITP","recombinant human thrombopoietin","eltrombopag","NOT_YET_RECRUITING",{"date":69,"type":38},"2026-07-01",{"date":71,"type":23},"2026-06",{"date":73,"type":23},"2028-03",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100610940","cd5-cart-for-the-treatment-of-relapsed-and-refractory-cd5-hematological-tumors-100610940","NCT07234110","CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors","Single-center, Single-arm Exploratory Clinical Study on the Safety and Efficacy of Human CD5 Chimeric Antigen Receptor T Cell Injection CD5CART in the Treatment of Relapsed and Refractory CD5+ Hematologic Cancer Subjects","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1\\. CD5-positive B-cell lymphoma: B-cell lymphoma confirmed according to the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2020 1st edition), and the tumor surface expresses CD5 (the test results within 60 days before signing the notice are acceptable for clinical practice, and the investigator will judge whether the test results of other hospitals are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with B-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm or bone marrow flow cytometry suggests bone marrow invasion, including:\n\n1. Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma: Received any BTK inhibitor for at least 6 months and was ineffective (disease is in SD or PD state).\n2. Mantle cell lymphoma: Relapsed\u002Frefractory disease with at least one treatment regimen, prior treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and therapy with any BTK inhibitor.\n3. Diffuse large B-cell lymphoma: Patients with diffuse large B-cell lymphoma who have refractory or relapsed after at least second-line therapy (one standard chemotherapy regimen and one salvage chemotherapy). At the same time, one of the following conditions is met: a. Unable to receive autologous hematopoietic stem cell transplantation; b. Refusal to receive autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation.\n\n2\\. CD5-positive T-cell lymphoma: Peripheral T-cell lymphoma confirmed according to the 2016 WHO classification criteria and the tumor surface expresses CD5 (if the current clinical practice is not suitable for sampling, the test results within 60 days before signing the information are acceptable, and the investigator will judge whether the test results of the other hospital are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with T-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm and no bone marrow invasion determined by bone marrow flow cytometry and receptor gene rearrangement (TCR\u002FIGH) testing (and if PET-CT is available, it must not indicate elevated bone marrow metabolism); Refractory or relapsed after at least first-line therapy, including, but not limited to, the following peripheral T-cell lymphomas:\n\n1. Peripheral T-cell lymphoma (non-specific type)\n2. angioimmunoblastic lymphoma\n3. ALK-negative mesentomas large cell lymphoma\n4. extranodal NK\u002FT-cell lymphoma\n5. enteropathy-associated T-cell lymphoma\n6. Large granular T lymphocytic leukemia\n7. Other CD5 T-cell tumors such as adult T-cell leukemia, such as acute T-lymphoblastic leukemia\u002FT-lymphoblastic lymphoma, etc 3. Age ≥ 18 and ≤ 70 years old, male or female. 4. Expected survival ≥ 12 weeks. 5. Serum total bilirubin ≤ 37.2 μmol\u002FL (serum total bilirubin ≤ 3.0 ULN and direct bilirubin ≤1.5 ULN in patients with Gilbert syndrome), estimated glomerular filtration rate eGFR (CKD-EPI) ≥ 30 ml\u002Fmin\u002F1.73m2, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times the upper limit of the normal range.\n\n6\\. ECOG score 0-1 points. 7. Left ventricular ejection fraction (LVEF) ≥ 50% of the subjects diagnosed by echocardiography; Blood oxygen saturation \\> 91%.\n\n8\\. Subjects and their spouses agree to take effective tools or drug contraceptives within one year after the subject signs the informed consent form until one year after CAR-T cell retransfusion; Female subjects of childbearing potential must have a negative serum or urine pregnancy test during the screening period.\n\n9\\. Volunteer to participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Those who have a history of allergy to any component of cell products.\n2. Grade II-IV. acute GVHD determined by Glucksberg criteria or grade B-D severity determined by IBMTR index; Patients with acute or chronic GVHD who required systemic treatment within four weeks prior to enrollment.\n3. Subjects who have been injected with live vaccines within 4 weeks before enrollment.\n4. Central nervous system diseases that are not related to lymphoma central invasion (such as brain aneurysm, epilepsy, stroke, Alzheimer's, psychosis, etc.). Lymphoma central invasion or gastrointestinal invasion is not used as an exclusion criterion, but enrollment is at the discretion of the investigator.\n5. Serious active infection (except uncomplicated urinary tract infection, bacterial pharyngitis), or currently receiving intravenous antibiotic therapy. However, prophylactic antibiotic, antiviral, and antifungal treatment for infections is allowed.\n6. Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection value \\> 100 IU\u002FmL.\n7. Those who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to those who are positive for human immunodeficiency virus (HIV) antibodies; Subjects with cytomegalovirus (CMV) DNA detection value \\> 400 copies\u002FmL; Those who test positive for syphilis.\n9. Subjects with cardiac insufficiency of class III or IV according to the New York Heart Association (NYHA) cardiac function grading criteria (see Appendix 2).\n10. Subject has a history of other primary cancers, except for the following:\n\n1\\) Non-melanoma cured by resection such as basal cell carcinoma of the skin; 2) Cured carcinoma in situ such as cervical cancer, bladder cancer or breast cancer, etc.; 3) No recurrence of other primary cancers after treatment for more than 5 years.\n\n11\\. History of solid organ transplantation. 12. Subjects with previous autoimmune diseases (mainly cellular immune abnormalities), immunodeficiency or subjects requiring immunosuppressant therapy.\n\n13\\. Receiving other interventional clinical trial drugs within 3 months before signing the informed consent form (ICF); 14. Women who are pregnant or breastfeeding; 15. Suffering from mental illness or consciousness disorder or central nervous system disease; 16. Previous treatment toxicity has not been resolved to baseline or grade ≤2 (NCI-CTCAE v5.0, except alopecia); 17. Medication use:\n\n1. Steroid medications: Therapeutic doses of steroids were used within 72 hours prior to CAR-T cell infusion, but physiologic doses of steroid supplementation are allowed (\\\u003C 12mg\u002Fm2\u002Fday of hydrocortisone or its equivalent;\n2. Systemic anti-tumor therapy requires at least 2 weeks or 5 half-lives of the drug before T cell collection (except for BTK inhibitors in CLL); T cells were collected from immune checkpoint inhibitors with an interval of less than 3 drug half-lives.\n\n18\\. Active pulmonary infection. 19. Contraindications to peripheral blood apheresis. 20. Subjects who are considered unsuitable to participate in this trial by the investigator after careful consideration.","1 Year","70 Years",{"count":85,"type":23},18,[59],"This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored",[89],"Relapsed and Refractory CD5 Hematological Tumors","2026-06-26",{"date":35,"type":38},{"date":93,"type":38},"2025-09-03",{"date":95,"type":23},"2027-10-31",{"name":44,"class":45},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":18,"minAge":104,"maxAge":83,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100645083","phase-1-a-multicenter-open-label-non-randomized-single-arm-phase-12-study-of-autologous-nano-cd5-car-t-cells-for-the-treatment-of-relapsedrefractory-t-cell-acute-lymphoblastic-leukemialymphoma-100645083","NCT07678307","A Multicenter, Open-label, Non-randomized, Single-arm Phase 1\u002F2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia\u002FLymphoma","A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase 1\u002F2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed\u002FRefractory T-Cell Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Age 3 to 70 years old\n* Diagnosed with CD5-positive relapsed\u002Frefractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)\n* ECOG performance status 0-2\n* Adequate organ function (renal, hepatic, cardiac, pulmonary)\n* Able to understand and sign informed consent\n\nExclusion Criteria:\n\n* Active severe infection or uncontrolled sepsis\n* History of allogeneic stem cell transplantation within 3 months\n* Severe autoimmune disease or immunodeficiency\n* Prior CD5-targeted therapy\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol","3 Years",{"count":85,"type":23},[107,26],"PHASE1","This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma.\n\nThe study will test a new treatment called \"autologous nano CD5-CAR T cells\". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells.\n\nThis study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works.\n\nYou may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts.\n\nPossible risks include fever, low blood pressure, and infection, which the study team will monitor closely.",[110,111,112],"T-Cell Acute Lymphoblastic Leukemia","T-Lymphoblastic Lymphoma","Relapsed\u002FRefractory Hematologic Malignancies",[114,115,116,117,118,119],"CD5-CAR-T Cell Therapy","Nano CAR-T","Relapsed Refractory T-ALL","Relapsed Refractory T-Lymphoblastic Lymphoma","Phase 1\u002F2 Clinical Trial","Hematologic Malignancies","2026-06-25",{"date":69,"type":38},{"date":35,"type":23},{"date":124,"type":23},"2027-12-31",{"name":44,"class":45},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100642533","phase-2-cm336-soc-for-dynamically-high-risk-multiple-myeloma-study-100642533","NCT07648459","CM336-SOC for Dynamically High-Risk Multiple Myeloma Study","A Prospective, Single-Arm, Single-Center, Phase II Clinical Study of CM336 Combined With SOC Therapy in Patients With Dynamically High-Risk Multiple Myeloma","CAREMM-013","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the informed consent form (ICF).\n2. Aged ≥18 and ≤75 years.\n3. Has measurable disease, meeting at least one of the following criteria: serum M-protein ≥5 g\u002FL as measured by serum protein electrophoresis (SPEP); or, for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; or urine M-protein ≥200 mg\u002F24 hours; if neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg\u002FL in the presence of an abnormal serum FLC ratio (normal FLC ratio: 0.26 to 1.65).\n4. Has received only one prior line of standard anti-myeloma therapy: standard induction therapy comprising at least two of the following: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; followed by autologous hematopoietic stem cell transplantation or consolidation therapy, and standard maintenance therapy.\n5. Meets the definition of functional high-risk multiple myeloma according to the EMN consensus: disease progression or relapse within 18 months after initiation of any first-line therapy.\n6. Liver function tests meet the following criteria: total bilirubin \\\u003C1.5 × upper limit of normal (ULN) (except that patients with Gilbert's syndrome must have total bilirubin \\\u003C3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.\n7. Renal function tests meet the following criterion: creatinine clearance ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n8. Complete blood count within 7 days before screening meets the following criteria: white blood cell (WBC) count ≥1.5 × 10⁹\u002FL, absolute neutrophil count ≥1.0 × 10⁹\u002FL, hemoglobin ≥70 g\u002FL, and platelet count ≥75 × 10⁹\u002FL if bone marrow plasma cells are \\\u003C50%, or platelet count ≥50 × 10⁹\u002FL if bone marrow plasma cells are ≥50%; or, in the investigator's judgment based on the actual clinical situation, the subject is considered suitable for enrollment.\n9. For patients receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists, etc. (e.g., eltrombopag, TPO, interleukin-11), there must be an interval of 2 weeks between growth factor support and screening assessment.\n10. For patients receiving blood product transfusions: there must be an interval of at least 2 weeks between the screening hemoglobin assessment and the last red blood cell (RBC) transfusion, and an interval of at least 1 week between the screening platelet assessment and the last platelet transfusion.\n11. The subject is able to receive the prophylactic anticoagulation recommended in the study.\n12. Female subjects of childbearing potential must meet both of the following conditions: agree to use effective contraception from the date of signing the informed consent form, during treatment with the study drug, and for 3 months after the last dose of the study drug; and have a negative serum pregnancy test result at screening.\n\nExclusion Criteria:\n\n1. Primary plasma cell leukemia or secondary plasma cell leukemia.\n2. Concurrent amyloidosis.\n3. Concurrent central nervous system (CNS) involvement.\n4. Prior treatment with BCMA-targeted therapy or CAR-T cell therapy.\n5. Known intolerance, allergy, or contraindication to glucocorticoids or BCMA\u002FCD3 bispecific antibody products.\n6. Clinically significant cardiac disease, including: myocardial infarction before randomization; or unstable or uncontrolled disease related to or affecting cardiac function, such as unstable angina, congestive heart failure, or New York Heart Association class III-IV cardiac function. Uncontrolled arrhythmia or clinically significant ECG abnormalities. Baseline corrected QT interval (QTc) \\>470 msec on 12-lead ECG at screening.\n7. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.\n8. Active hepatitis B or C infection. Hepatitis serology testing is required at screening. If hepatitis B surface antigen or hepatitis B core antibody is positive, a negative DNA polymerase chain reaction (PCR) result must be confirmed before enrollment; for patients receiving anti-hepatitis B antiviral therapy, a negative DNA PCR result must be confirmed before enrollment. If hepatitis C antibody is positive, RNA PCR testing must be performed, and a negative result must be confirmed before enrollment.\n9. Pregnant or breastfeeding women.\n10. Life expectancy \\\u003C6 months.\n11. Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect absorption of the study treatment.\n12. Major surgery within 2 weeks before the start of randomization, such as surgery requiring general anesthesia; incomplete recovery from surgery; or planned surgery during the study period. Kyphoplasty or vertebroplasty is not considered major surgery.\n\n    Note: Subjects scheduled to undergo surgical procedures under local anesthesia may participate in the study.\n13. Receipt of a live attenuated vaccine within 4 weeks before the first dose of study drug.",{"count":135,"type":23},46,[26],"This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma.",[139],"Multiple Myeloma",[32,141,33],"multiple myeloma","2026-06-11",{"date":144,"type":38},"2026-06-15",{"date":146,"type":23},"2026-06-01",{"date":148,"type":23},"2028-07-30",{"name":44,"class":45},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":46},"100641588","phase-2-cm336-plus-isa-vr-in-newly-diagnosed-primary-plasma-cell-leukemia-100641588","NCT07652905","CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia","A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Isatuximab, Lenalidomide, and Bortezomib in Newly Diagnosed Primary Plasma Cell Leukemia","CAREMM-011","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign a written informed consent form (ICF).\n2. Age 18 to 75 years.\n3. Newly diagnosed primary plasma cell leukemia (pPCL) according to International Myeloma Working Group (IMWG) criteria, defined as either:\n\n   * ≥5% circulating plasma cells on peripheral blood smear; or\n   * Absolute circulating plasma cell count \\>2 × 10⁹\u002FL.\n\n   Patients who have received no more than one prior cycle of anti-myeloma therapy before enrollment are eligible, provided they have not received monoclonal antibodies or immunotherapy agents.\n4. Measurable disease, defined by at least one of the following:\n\n   * Serum M-protein ≥10 g\u002FL as measured by serum protein electrophoresis (SPEP); for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead;\n   * Urine M-protein ≥200 mg\u002F24 hours;\n   * If neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg\u002FL with an abnormal serum FLC ratio (normal range: 0.26-1.65).\n5. Adequate hepatic function, defined as:\n\n   * Total bilirubin \\\u003C1.5 × upper limit of normal (ULN), except for participants with Gilbert syndrome, who must have total bilirubin \\\u003C3 × ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.\n6. Adequate renal function, defined as creatinine clearance ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n7. Adequate hematologic function within 7 days prior to enrollment, defined as:\n\n   * White blood cell (WBC) count ≥1.5 × 10⁹\u002FL;\n   * Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL;\n   * Hemoglobin ≥70 g\u002FL;\n   * Platelet count ≥50 × 10⁹\u002FL;\n\n   Alternatively, eligibility may be determined by the investigator based on clinical judgment.\n8. Participants receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or thrombopoietic agents, must have a washout period of at least 2 weeks between the last administration of growth factor support and screening assessments.\n9. Participants receiving blood product transfusions must meet the following requirements:\n\n   * At least 2 weeks between the last red blood cell (RBC) transfusion and hemoglobin assessment at screening;\n   * At least 1 week between the last platelet transfusion and platelet count assessment at screening.\n10. Able and willing to receive protocol-recommended prophylactic anticoagulation therapy.\n11. Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception from the time of signing the informed consent form, throughout study treatment, and for at least 3 months after the last dose of study treatment.\n\nMale participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must not plan to father a child from the time of signing informed consent through 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.\n2. Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.\n3. Known intolerance, hypersensitivity, allergy, or contraindication to CM336, isatuximab, bortezomib or lenalidomide.\n4. Severe and\u002For uncontrolled cardiovascular disease, including:\n\n   Unstable angina; Symptomatic congestive heart failure; Myocardial infarction within 6 months prior to enrollment; Severe and uncontrolled cardiac arrhythmias; Any other cardiovascular or cerebrovascular condition deemed by the investigator to make participation inappropriate.\n5. Active infection, including:\n\n   Human immunodeficiency virus (HIV) infection; Active hepatitis B infection (HBV DNA positive); Active hepatitis C infection (HCV RNA positive); Active or latent syphilis infection (positive Treponema pallidum antibody test); Active pulmonary tuberculosis, as evidenced by chest imaging or other relevant assessments within 3 months prior to screening or during the screening period; Any other infection considered by the investigator to make participation inappropriate.\n6. Concurrent active malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with study participation.\n7. Pregnant or breastfeeding women.\n8. Estimated life expectancy of less than 6 months.\n9. Active gastrointestinal disorders that may impair the participant's ability to swallow oral medication or may interfere with the absorption of study treatment.\n10. Major surgery within 2 weeks prior to enrollment (e.g., surgery requiring general anesthesia), incomplete recovery from prior surgery, or planned major surgery during study participation. Kyphoplasty and vertebroplasty are not considered major surgery. Participants undergoing procedures under local anesthesia may be eligible.\n11. Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.\n12. Any active severe psychiatric disorder, medical condition, symptom, or other circumstance that, in the investigator's judgment, may interfere with treatment, protocol compliance, or the ability to provide informed consent.\n13. Inability or unwillingness to provide written informed consent.",{"count":159,"type":23},24,[26],"The goal of this clinical trial is to learn whether CM336, a BCMA\u002FCD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination.\n\nThe main questions it aims to answer are:\n\nHow many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study.\n\nParticipants will:\n\nReceive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles.\n\nUndergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety.\n\nHave stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.\n\nBe monitored throughout the study for side effects.",[163],"Plasma Cell Leukemia (PCL)",[32,33,165],"Primary plasma cell leukemia",{"date":167,"type":38},"2026-06-17",{"date":169,"type":23},"2026-06-20",{"date":171,"type":23},"2031-12-30",{"name":44,"class":45},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100642813","phase-2-immuno-targeted-therapy-plus-low-dose-chemotherapy-for-newly-diagnosed-adult-ph-negative-b-all-a-prospective-umbrella-trial-100642813","NCT07643103","Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial","A Prospective Umbrella Clinical Trial of Immuno-Targeted Agents Combined With Low-Dose Chemotherapy for Newly Diagnosed Adult Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia","Ph- ALL-2026","Inclusion Criteria:\n\n1. Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.\n2. CD22-positive expression on tumor cells (CD22 ≥20%).\n3. Expected survival ≥3 months.\n4. Sexually active men and women of childbearing potential must agree to use effective contraception.\n5. Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures.\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia.\n2. Acute leukemia of ambiguous lineage.\n3. Pregnant women.\n4. Severe, uncontrolled active infections.\n5. History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) \u002F sinusoidal obstruction syndrome (SOS).\n6. History of clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), or sinus node dysfunction or high-grade atrioventricular (AV) block with chronic bradycardia, unless a permanent pacemaker has been implanted.\n7. Uncontrolled active hepatitis B or hepatitis C infection, or known HIV seropositivity. HIV testing may be required according to local regulations or standards.\n8. Psychiatric disorders that may impair the subject's ability to complete treatment or provide informed consent.\n9. Any other conditions deemed by the investigator to render the subject unsuitable for participation in the study.",{"count":182,"type":23},32,[26],"This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.\n\nThe primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.",[186],"Ph- Acute Lymphoblastic Leukemia (Ph-ALL)","2026-06-08",{"date":142,"type":38},{"date":190,"type":23},"2026-06-12",{"date":192,"type":23},"2030-05-31",{"name":44,"class":45},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100642409","efficacy-and-safety-of-the-clob2m-clofarabine-combined-with-busulfan-and-melphalan-conditioning-regimen-in-allogeneic-hematopoietic-stem-cell-transplantation-for-adult-patients-with-acute-myeloid-leukemia-in-first-complete-remission-100642409","NCT07644481","Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission","Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission: An Open-Label, Prospective, Single-Arm Clinical Trial","Inclusion Criteria:\n\n* 1.Aged from 18 to 60 years inclusive, with no restriction on gender;\n* 2.Patients diagnosed with acute myeloid leukemia (AML, excluding acute promyelocytic leukemia, APL) by bone marrow morphological, immunological and genetic examinations according to the 2022 World Health Organization (WHO) classification, who have achieved first complete remission (CR1) after induction therapy;\n* 3.Meeting any of the following criteria upon clinical evaluation:\n\n  1. AML classified as intermediate or adverse genetic risk according to the 2022 ELN genetic risk stratification;\n  2. AML with positive measurable residual disease (MRD) before transplantation;\n* 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-2;\n* 5.Estimated survival time more than 6 months;\n* 6.Meeting the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and having an eligible hematopoietic stem cell donor with qualified physical examination, including HLA-matched sibling donor, unrelated donor (high-resolution HLA 9-10\u002F10 matched) or haploidentical related donor;\n* 7.Adequate major organ function meeting the following criteria:\n\n  1. Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3 × ULN;\n  2. Serum creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault glomerular filtration formula;\n  3. Coagulation function meeting the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);\n  4. Electrocardiogram showing no acute myocardial infarction or severe arrhythmia; Echocardiography with left ventricular ejection fraction (LVEF) ≥ 50%, without significant cardiomegaly, valvular heart disease or congenital heart disease;\n  5. Pulmonary function tests: FEV1, FVC and DLCO ≥ 60% of predicted value;\n* 8.Willing to provide available diagnostic evidence or undergo bone marrow aspiration and biopsy prior to study treatment, and agree to receive regular bone marrow aspiration and biopsy after study treatment;\n* 9.Must sign the informed consent form prior to study enrollment, signed by the patient personally or immediate family members. If signature by the patient is deemed detrimental to disease treatment based on clinical condition assessment, the informed consent shall be signed by the legal guardian or immediate family member of the patient.\n\nExclusion Criteria:\n\n* 1.Refractory\u002Frelapsed AML;\n* 2.Known hypersensitivity to any drugs in the conditioning regimen or their excipients;\n* 3.Major surgery within the past 4 weeks (excluding diagnostic surgical procedures);\n* 4.History of or concurrent other malignant tumors (excluding well-controlled non-melanoma basal cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, and other malignancies well controlled without treatment for more than five years);\n* 5\\. Uncontrolled systemic diseases (such as uncontrolled hypertension, diabetes mellitus, etc.);\n* 6.Active hepatitis B or hepatitis C infection:（Hepatitis B virus surface antigen positive, hepatitis B core antibody positive with HBV-DNA level exceeding 1×103 copies\u002FmL;Hepatitis C virus RNA level exceeding 1×10 3 copies\u002FmL）;\n* 7.Uncontrolled ongoing infection, or patients requiring mechanical ventilation or with hemodynamic instability;\n* 8.Patients with psychiatric disorders or other medical conditions who are unable to comply with study treatment and monitoring requirements;\n* 9.Participation in another ongoing clinical trial, or enrollment in any other drug clinical trial within the past 1 month;\n* 10.Pregnant or lactating females, and patients who refuse to use effective contraception during the study period;\n* 11.Patients who are unable to understand the trial protocol, adhere to medication instructions, or refuse to sign the informed consent form;\n* 12.Patients deemed ineligible for enrollment by the investigator.","60 Years",{"count":203,"type":23},30,[59],"This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.",[207,208],"AML (Acute Myelogenous Leukemia)","Allogeneic Hematopoietic Stem Cell Transplantation Recipient",{"date":190,"type":38},{"date":211,"type":23},"2026-07-20",{"date":213,"type":23},"2029-12-31",{"name":44,"class":45},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":234,"locationsCount":235},"100635652","phase-2-mosunetuzumab-and-zeprumetostat-in-treating-patients-with-follicular-lymphoma-100635652","NCT07555470","Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma","A Prospective, Multicenter, Phase 2 Study of Mosunetuzumab in Combination With Zeprumetostat for the Treatment of Follicular Lymphoma","CUREFL03","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate hematologic and organ function\n* Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use highly effective contraception; male subjects must agree to use effective contraception.\n* Voluntary written informed consent\n* Cohort 1- Previously Untreated High-Risk FL：\n\n  1. Histologically confirmed Grade 1-3a follicular lymphoma (FL), CD20-positive, with no evidence of histologic transformation\n  2. Ann Arbor Stage III\u002FIV\n  3. No prior systemic therapy for FL\n  4. Meeting at least one of the GELF criteria for indicating treatment\n  5. FLIPI-1 or FLIPI-2 score of 3 to 5 (High risk)\n* Cohort 2- Previously Untreated Low-Tumor-Burden FL：\n\n  1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III\u002FIV FL with no prior systemic therapy.\n  2. Absence of B symptoms or severe pruritus\n  3. Low tumor burden (LTB) not meeting GELF criteria for treatment\n  4. Must have at least one measurable lesion (longest diameter \\>1.5 cm)\n  5. Patients who are suffering from the disease or prefer active management over a watch-and-wait approach\n* Cohort 3-Relapsed or Refractory FL：\n\n  1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III\u002FIV FL with no evidence of histologic transformation.、\n  2. Relapsed or refractory disease, having received at least 1 prior systemic therapy regimen containing an anti-CD20 antibody\n  3. No prior treatment with a CD20\u002FCD3 bispecific antibody or an EZH2 inhibitor\n  4. Presence of at least one measurable or evaluable lesion at relapse\n\nExclusion Criteria:\n\n* Central nervous system (CNS) lymphoma, primary mediastinal lymphoma, or evidence of histologic transformation.\n* Uncontrolled cardiovascular, cerebrovascular, coagulopathy, connective tissue, or severe infectious diseases.\n* Pregnant or lactating women.\n* Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) infection (RNA PCR positive).\n* Concurrent other malignancies or history of malignancies, or anti-cancer therapy (including major surgery) within the last 4 weeks.\n* Allergic reaction to the study drugs.\n* Concurrent use of strong CYP3A4 inhibitors or strong CYP3A4 inducers that cannot be avoided\n* Other medical or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.",{"count":224,"type":23},80,[26],"The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). The study plans to enroll approximately 80 patients, who will be assigned to three distinct cohorts: previously untreated high-risk FL (Cohort 1), previously untreated low-tumor-burden FL (Cohort 2), and relapsed or refractory FL (Cohort 3). The study consists of a safety run-in phase, which will be initially conducted in Cohort 1 to assess the tolerability of the combination therapy, followed by an expansion phase across all three cohorts to further evaluate the clinical outcomes.",[228],"Follicular Lymphoma",{"date":230,"type":38},"2026-06-09",{"date":232,"type":38},"2026-04-10",{"date":213,"type":23},{"name":44,"class":45},2,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":46},"100630639","venetoclax-azacitidine-and-liposomal-mitoxantrone-for-newly-diagnosed-aml-100630639","NCT07490288","Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML","A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS\u002FAML as defined by ICC (with 10%-20% blasts in the bone marrow)\n* Age ≥ 14 years, male or female.\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):\n\n  i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.\n\nii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \\\u003C 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \\\u003C 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML::RARA fusion gene.\n* Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.\n* Acute myeloid leukemia with BCR::ABL1 fusion gene.\n* Previously treated patients (defined as having received prior induction chemotherapy for AML\u002FMDS; prior use of cytoreductive agents like hydroxyurea is allowed).\n* Concurrent active malignancy of other organs (requiring treatment).\n* Active cardiac disease, defined as one or more of the following:\n\n  i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.\n\niv. Uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] Class 2).\n\n* Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.","14 Years","100 Years",{"count":246,"type":23},27,[59],"This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.\n\nThe study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.",[250],"AML",{"date":230,"type":38},{"date":253,"type":38},"2026-05-08",{"date":255,"type":23},"2029-03-01",{"name":44,"class":45},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":24,"phases":266,"briefSummary":267,"conditions":268,"keywords":274,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100630638","phase-1-allogeneic-cd19bcma-targeted-car-t-cell-therapy-safety-and-preliminary-pharmacodynamics-in-relapsedrefractory-autoimmune-diseases-100630638","NCT07490275","Allogeneic CD19\u002FBCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed\u002FRefractory Autoimmune Diseases","Safety and Preliminary Pharmacodynamics of Allogeneic CD19\u002FBCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥18 years (including 18 years), no gender restrictions.\n* Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.\n* Major organ function must meet the following requirements (excluding abnormalities related to active autoimmune disease):\n* Bone marrow function: Neutrophil count ≥ 1 × 10\\^9\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g\u002FL.\n* Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).\n* Renal function: Creatinine clearance (CrCl) ≥ 30 ml\u002Fmin (calculated using the Cockcroft-Gault formula, excluding acute CrCl decline due to target disease; lupus nephritis (LN) patients excluded).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstain from sexual intercourse for at least 6 months during study treatment and for at least 6 months after study treatment completion.\n* Voluntary participation in this clinical study, signing of informed consent, good compliance, and ability to complete follow-up.\n\nDisease-specific inclusion criteria:\n\n* Relapsed\u002Frefractory systemic lupus erythematosus\n* Diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria.\n* Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) ≥ 8 points; or significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of type III or IV, with or without type V involvement; National Institutes of Health \\[NIH\\] activity score \\> 2 points; evidence of elevated chronicity index; urine protein\u002Fcreatinine ratio \\> 1.0 g\u002Fg, or 24-hour urine protein quantification \\> 1.0 g).\n* Refractory or recurrent disease is defined as: no response after more than 6 months of conventional therapy, or recurrence of disease activity following remission. Conventional therapy is defined as: glucocorticoids combined with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, or tatalimab.\n* Refractory\u002FRecurrent\u002FProgressive Systemic Sclerosis\n* Scleroderma diagnosis conforms to the 2013 ACR（American College of Rheumatology） classification criteria.\n* Positive for scleroderma-associated antibodies.\n* Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n* Definition of recurrent\u002Frefractory: No response to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Progressive definition: Rapid progression of cutaneous lesions (Modified Rodnan Skin Score (mRSS) increase \\> 25%); or progression of pulmonary lesions (Forced Vital Capacity (FVC) decline ≥10%, or FVC decline ≥5% accompanied by Diffusion Capacity for Carbon Monoxide (DLCO) decline ≥15%).\n\nNote: Fulfilment of either criterion 4 or 5 is sufficient.\n\n* Refractory\u002FRecurrent\u002FProgressive Inflammatory Myopathies\n* Diagnosis of inflammatory myopathy conforms to the 2017 EULAR（European Alliance of Associations for Rheumatology）\u002FACR classification criteria (including dermatomyositis (DM), polymyositis (PM), anti-synthetase syndrome (ASS), and necrotising myopathy (NM)).\n* Muscle involvement present, Manual Muscle Test - 8 (MMT-8) score \\\u003C 142 points, and at least 2 abnormalities in the following 5 core indicators: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire (HAQ) total score ≥ 0.25 points; Muscle enzyme levels ≥1.5 times the upper limit of normal.\n* Definition of recurrent\u002Frefractory: No response to conventional therapy for over 6 months, or relapse following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Definition of progressive disease: Rapid progression of interstitial lung disease within a short timeframe.\n\nNote: Meeting any one criterion from either section 4 or 5 suffices.\n\n* Refractory\u002FRecurrent Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis\n* Diagnosis of ANCA-associated vasculitis conforms to the 2022 ACR\u002FEULAR criteria, encompassing microscopic polyangiitis, granulomatous polyangiitis, and eosinophilic granulomatous polyangiitis.\n* ANCA-associated antibody testing is positive (myeloperoxidase antibody \\[MPO-ANCA\\] or proteinase 3 antibody \\[PR3-ANCA\\] positive).\n* Birmingham Vasculitis Activity Score (BVAS) ≥15 points (out of 63 total points), indicating active vasculitis.\n* Refractory\u002Frecurrent definition: Failure to respond to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy is defined as:Use of glucocorticoids in combination with any one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Refractory\u002FRecurrent Connective Tissue Disease-Associated Thrombocytopenia\n* Diagnosis of connective tissue disease conforming to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n* Diagnosed with connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C 30 × 10⁹\u002FL, or platelet count \\\u003C 50 × 10⁹\u002FL accompanied by bleeding tendency.\n* Bone marrow morphology consistent with features of immune thrombocytopenia.\n* Previous treatment with at least one course of glucocorticoid pulse therapy, or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics) for at least three months, failing to achieve partial remission or unable to maintain efficacy during glucocorticoid tapering.\n\nExclusion Criteria:\n\n* -Individuals with a history of severe drug allergies or an allergic constitution.\n* Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.\n* Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).\n* Patients with cardiac insufficiency.\n* Patients with congenital immunoglobulin deficiency.\n* History of malignant tumours within the past five years.\n* End-stage renal disease (excluding lupus nephritis (LN) patients).\n* Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA \\> upper limit of normal; hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; positive syphilis test.\n* Individuals with psychiatric disorders or severe cognitive impairment.\n* Participants who have been enrolled in another clinical trial within the three months preceding study entry.\n* Individuals who have received immunosuppressive agents or biological agents for therapeutic indications within five half-lives prior to study entry.\n* Pregnant women or women planning pregnancy.\n* Individuals deemed by the investigator to have other conditions rendering them unsuitable for inclusion in this study.",{"count":265,"type":23},9,[107],"This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19\u002FBCMA-targeted CAR-γδT cell in the treatment of relapsed\u002Frefractory autoimmune diseases",[269,270,271,272,273],"Refractory\u002FRelapsed Systemic Lupus Erythematosus","Refractory \u002F Relapsed \u002F Progressive Systemic Sclerosis","Refractory \u002F Relapsing \u002F Progressive Inflammatory Myopathy","Refractory \u002F Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Refractory \u002F Relapsed Connective Tissue Disease-Associated Thrombocytopenia",[275,276,277],"CD19\u002FBCMA","CAR-γδT","cell therapy",{"date":230,"type":38},{"date":69,"type":23},{"date":281,"type":23},"2028-12-31",{"name":44,"class":45},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":46},"100561782","phase-1-r-cmop-in-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100561782","NCT06594640","R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","A Multicenter, Prospective Phase I\u002FII Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination With Cyclophosphamide, Vincristine, Prednisone, and Rituximab in Patients With Newly Diagnosed DLBCL","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;\n3. Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;\n4. There must be at least one measurable lesion per the Lugano2014 criteria；\n5. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；\n6. Ann Arbor stages II-IV；\n7. ECOG score 0\\~2；\n8. Expected survival time ≥3 months;\n9. a.)Patients should meet the following requirements and must not have received treatment with cell growth factors or blood products within 14 days prior to the hematology test: Absolute value of neutrophils ≥ 1.5 × 10\\^9\u002FL; Platelet ≥ 75 × 10\\^9\u002FL; Hemoglobin≥80g\u002FL. For patients with bone marrow involvement of lymphoma, the requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL; Platelet count ≥ 50 × 10\\^9\u002FL; Hemoglobin level ≥ 75 g\u002FL.\n\n   b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); c.)Creatinine clearance ≥ 50 mL\u002Fmin or serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5;\n10. Female patients of childbearing age must have a negative pregnancy test at the time of enrollment within one week. And patients must agree to use an effective method of contraception from the study initiation until at least 12 months after the last treatment;\n11. Able to understand and comply with the study, and voluntarily sign informed consent; -\n\nExclusion Criteria:\n\n1. Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis, ALK-positive large B-cell lymphoma, Plasmablastic lymphoma, HHV8-positive DLBCL, Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell\u002Fhistiocyte-rich large B-cell lymphoma, and High-grade B-cell lymphoma；\n2. transformed indolent lymphoma ;\n3. Patients with active central nervous system involvement;\n4. History of hematopoietic stem cell transplantation;\n5. Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;\n6. Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;\n7. History of allergy and contraindications to the same class and excipients of the experimental drug;\n8. Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study;\n9. Active bacterial or viral infections requiring systemic or intravenous drug treatment.\n10. History of immunodeficiency, including anti-HIV positive;\n11. Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper limit of normal);\n12. syphilis infection;\n13. Individuals with an underlying medical condition, alcohol or drug abuse or dependence that impedes study drug administration or interferes with interpretation of study drug toxicity and AE, or results in inadequate or reduced adherence to the study;\n14. Patients with interstitial lung disease that requires treatment; 15: A history of severe cardiovascular disease, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second to third-degree atrioventricular (AV) block;\n    2. A mean QTcF interval longer than 450 ms, based on three 12-lead ECGs taken at rest;\n    3. Acute coronary syndrome, congestive heart failure, stroke, or any other Grade 3 or higher cardiovascular event occurring within 6 months prior to the first dose of therapy;\n    4. NYHA functional class ≥ II or left ventricular ejection fraction (LVEF)lower than 50%;\n    5. Any factors that increase the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or unexplained sudden death in a first-degree relative under the age of 40, or concurrent use of any medications known to prolong the QT interval;\n    6. uncontrolled hypertension;\n\n16\\. History of other malignant tumor within 2 years, except for DLBCL in this trial or resected locally cancer that has been cured (e.g.basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast); 17. No psychological, spiritual potentially hampering compliance with the study protocol and follow-up schedule; 18. Women who are pregnant or breastfeeding; 19. Any other reasons deemed by the investigator to render the participant unsuitable for inclusion in this clinical trial.\n\n\\-",{"count":291,"type":23},108,[107,26],"This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma",[295],"Diffuse Large B-cell Lymphoma",[297,295],"Mitoxantrone hydrochloride liposome injection",{"date":299,"type":38},"2026-06-10",{"date":301,"type":38},"2024-05-30",{"date":303,"type":23},"2027-07-30",{"name":44,"class":45},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":312,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":24,"phases":315,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100640689","phase-3-dagoat-guided-prevention-of-severe-agvhd-after-allo-hsct-100640689","NCT07588945","daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT","A Multicenter Randomized Controlled Trial of daGOAT Model-guided Prevention of Severe Acute Graft-versus-host Disease in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age \\> 16 years old.\n2. HLA-haploidentical transplant.\n3. Able to take oral medications.\n4. Patients must provide written informed consent before the start of the study procedures.\n\nExclusion Criteria:\n\n1. Patients who have undergone tandem transplantation or multiple transplantations.\n2. Patients who are allergic to or cannot tolerate ruxolitinib.\n3. Patients with mental or other medical conditions that make them unable to comply with the study treatment and monitoring requirements.\n4. Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.","16 Years",{"count":314,"type":23},438,[316],"PHASE3","This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.",[319],"Transplant-Related Disorder","2026-05-10",{"date":322,"type":38},"2026-05-15",{"date":146,"type":23},{"date":325,"type":23},"2028-06-01",{"name":44,"class":45},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100640682","phase-2-a-exploratory-study-on-untreated-follicular-lymphoma-with-orelabrutinib-tafasitamab-and-lenalidomide-100640682","NCT07585747","A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide","A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide","CUREMZL002","Inclusion Criteria:\n\n1. Age \\> 18 years, regardless of gender;\n2. Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;\n3. Deemed by the investigator to have an indication for treatment and require therapy;\n4. ECOG performance status score of 0-2;\n5. Laboratory tests meeting the following criteria:\n\n   1. Bone marrow hematopoietic function is essentially normal: WBC 3.5x10\\^9\u002FL, ANC \\> 1.0x10\\^9\u002FL, PLT \\> 75x10\\^9\u002FL, Hb \\> 80 g\u002FL;\n   2. Liver function: AST\u002FALT s 2xULN, TBILI s 2xULN;\n   3. Renal function: Creatinine clearance rate \\> 50 ml\u002Fmin;6. Presence of at least one measurable lesion: Lymph node lesion with a long diameter \\> 1.5 cm orextranodal lesion with a long diameter \\> 1.0 cm as shown by PET\u002FCT, CT, or MRl, or a lesion \\> 2cm assessed by clinical examination;\n\n7\\. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Women with a positive serum pregnancy test or who are breastfeeding;\n2. Patients with lymphoma involving the central nervous system (CNS);\n3. Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction \\\u003C50%;\n4. Patients with grade \\>2 neuropathy;\n5. Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired\u002Fcongenitalimmunodeficiency diseases;\n6. Patients with severe active infections requiring systemic antibiotic treatment;\n7. Patients with a history of severe neurological or psychiatric disorders that impair trialparticipation, including dementia, epilepsy, severe depression, and mania;8. Drug abuse, or medical, psychological, or social conditions that may interfere with studyparticipation or result evaluation;\n\n9\\. Patients deemed ineligible by the investigator.",{"count":246,"type":23},[26],"Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.",[228],[340,341,342],"lenalidomide","tafasitamab","orelabrutinib",{"date":344,"type":38},"2026-05-14",{"date":346,"type":23},"2026-04-15",{"date":348,"type":23},"2030-12-31",{"name":44,"class":45},5,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":46},"100630860","chemotherapy-with-targeted-immunotherapy-for-newly-diagnosed-ph-all-100630860","NCT07493161","Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL","Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study","Inclusion Criteria:\n\n* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).\n* Age ≥ 14 years.\n* ECOG performance status ≤ 2.\n* Adequate organ function: Total bilirubin \\\u003C1.5x ULN; AST\u002FALT ≤2.5x ULN; Serum creatinine \\\u003C2x ULN; Cardiac enzymes \\\u003C2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \\>45%.\n* Male and female patients of childbearing potential must agree to use effective contraception.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.\n* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).\n* Myocardial infarction within 12 months prior to enrollment; uncontrolled\u002Funstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.\n* Uncontrolled active severe infection.\n* Active psychiatric illness that may hinder treatment completion or informed consent.\n* Any other condition deemed unsuitable for the study by the investigator.",{"count":359,"type":23},110,[59],"This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.",[363],"Ph+ ALL",{"date":365,"type":38},"2026-05-13",{"date":232,"type":38},{"date":368,"type":23},"2030-03-30",{"name":44,"class":45},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":201,"enrollmentInfo":377,"targetDuration":4,"studyType":24,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":46},"100627868","abljak-inhibitors-with-chemotherapy-and-venetoclax-for-ph-like-all-100627868","NCT07454226","ABL\u002FJAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL","An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL","Inclusion Criteria:\n\n* Age ≥14 years and ≤60 years, regardless of gender\n* ECOG performance status score ≤2\n* Male and female participants of childbearing potential agree to and adopt effective contraceptive measures\n* Criteria for major organ function assessment: total bilirubin \\\u003C1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; serum creatinine \\\u003C2 × ULN; myocardial enzymes \\\u003C2 × ULN; serum amylase ≤1.5 × ULN; left ventricular ejection fraction (LVEF) \\>45% as shown by cardiac ultrasound\n\nExclusion Criteria:\n\n* Pregnant women\n* Severe uncontrolled active infections\n* Mental illnesses that may hinder the completion of treatment or informed consent\n* Other conditions deemed unsuitable for this study by the investigator",{"count":378,"type":23},92,[59],"This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation\u002Ffusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol.\n\nThe primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.",[382,383],"Ph-Like","Acute Lymphoblastic Leukemia",{"date":365,"type":38},{"date":386,"type":23},"2026-05-30",{"date":388,"type":23},"2030-03-01",{"name":44,"class":45},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":201,"enrollmentInfo":397,"targetDuration":4,"studyType":24,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":407,"locationsCount":46},"100631050","pediatric-inspired-regimen-combined-with-venetoclax-and-immunotherapy-for-adult-ph-negative-acute-lymphoblastic-leukemia-100631050","NCT07495631","Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated (except prednisone\u002Fhydroxyurea) Ph-negative ALL\n* Age ≥14 years, ≤60 years\n* ECOG performance status ≤2\n* Adequate organ function (liver, kidney, cardiac)\n* For patients of childbearing potential: use of effective contraception\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma\n* Acute leukemia of ambiguous lineage\n* Pregnancy or lactation\n* Severe uncontrolled active infection\n* History of pancreatitis\n* Uncontrolled diabetes (HbA1c \\>7.5%)\n* Active gastrointestinal bleeding within 6 months\n* Arterial\u002Fvenous thrombosis within 6 months\n* Known HIV positivity\n* Severe psychiatric illness hindering compliance\n* Any other condition deemed unsuitable by the investigator",{"count":398,"type":23},43,[59],"This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.",[402],"Acute Lymphoblastic Leukemia, Adult",{"date":365,"type":38},{"date":405,"type":38},"2026-04-08",{"date":388,"type":23},{"name":44,"class":45},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":24,"phases":419,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":235},"100615941","phase-2-zanubrutinib-obinutuzumab-combined-with-lenalidomide-zgr-for-the-treatment-of-untreated-follicular-lymphoma-100615941","NCT07299149","Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma","A Prospective, Open-label, Single-arm Multicenter Clinical Study of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Untreated Follicular Lymphoma","ZGR in TN FL","Inclusion Criteria:\n\n* Gender: No restrictions; age ≥18 years.\n* Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis.\n* Disease Stage \\& Treatment Need:\n* Stage III or IV disease, or Stage II with bulky disease, meeting at least one of the following criteria:\n* a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm.\n* b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass.\n* c) B symptoms (fever, night sweats, or unintentional weight loss \\>10% of body weight within ≤6 months).\n* d) Symptomatic extranodal involvement (e.g., pleural\u002Fperitoneal effusion).\n* e) Cytopenias due to bone marrow infiltration (hemoglobin \\\u003C10 g\u002FdL, absolute neutrophil count \\[ANC\\] \\\u003C1.0×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL).\n* f) Involvement of ≥3 lymph nodes, each ≥3 cm in diameter.\n* g) Symptomatic splenomegaly.\n* Prior Therapy: No prior systemic therapy for FL.\n* ECOG Performance Status: ≤2.\n* Measurable Disease: At least one measurable lesion (\\>2 cm in longest diameter by CT\u002FMRI).\n* Life Expectancy: ≥6 months.\n* Adequate Organ Function:\n* a) ANC ≥1.0×10⁹\u002FL (without growth factor support).\n* b) Platelets ≥50×10⁹\u002FL (untransfused within 7 days).\n* c) Total bilirubin (TBIL) ≤1.5×ULN.\n* d) ALT\u002FAST ≤3×ULN.\n* e) Creatinine clearance ≥30 mL\u002Fmin (calculated by modified Cockcroft-Gault formula).\n* Contraception: Men and women of childbearing potential must agree to use highly effective contraception during the study and for 4 weeks after treatment discontinuation.\n* Informed Consent: Patients must voluntarily participate and sign informed consent forms (ICF).\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n* Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL).\n* Grade 3B follicular lymphoma (FL) or transformed FL.\n* Ann Arbor Stage I FL.\n* Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear).\n* Use of any investigational drugs, antibiotics, or participation in another interventional clinical trial within 4 weeks prior to enrollment.\n* Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated need for major surgery during the study.\n* Prior treatment with zanubrutinib, obinutuzumab, or lenalidomide.\n* Immunodeficiency or autoimmune disease history, or chronic systemic steroid therapy (\\>10 mg\u002Fday prednisone equivalent) or immunosuppressive therapy within 7 days before enrollment.\n* Severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome), cachexia, or multi-organ failure with renal impairment.\n* Clinically significant cardiovascular abnormalities:\n* NYHA Class III\u002FIV heart failure\n* Myocardial infarction within 6 months before enrollment, Malignant arrhythmias (including QTc ≥480 ms), Uncontrolled hypertension (Systolic blood pressure (SBP) ≥150 mmHg and diastolic blood pressure (DBP) ≥100 mmHg), Unstable angina.\n\nActive infections:\n\n* HIV, active hepatitis B\u002FC infection (HBV DNA ≥2000 IU\u002FmL or HCV RNA detectable)\n* Uncontrolled systemic infections.\n* Bleeding disorders or coagulation abnormalities, or thrombotic events within 3 months.\n* Severe hypersensitivity to the active ingredients or excipients of the study drugs.\n* Pregnancy, lactation, or unwillingness to use effective contraception in women of childbearing potential.\n* Other conditions deemed unsuitable by the investigator.","90 Years",{"count":418,"type":23},34,[26],"This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.",[228],[423,424,425,340],"follicular lymphoma","zanubrutinib","Obinutuzumab",{"date":365,"type":38},{"date":428,"type":38},"2025-12-25",{"date":430,"type":23},"2030-12-25",{"name":44,"class":45},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":235},"100613021","phase-2-obinutuzumab-zanubrutinib-and-lenalidomide-in-first-line-treatment-of-mantle-cell-lymphoma-100613021","NCT07261163","Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma","Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study","Inclusion Criteria:\n\n1. Age between 18 and 80 years inclusive, both genders are eligible.\n2. Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.\n3. No prior systemic therapy for MCL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Adequate organ function, defined as:\n\n   1. Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹\u002FL;Platelet count (PLT) ≥ 75 × 10⁹\u002FL;\n   2. Biochemical tests must meet the following criteria::\n\n      Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL\u002Fmin, calculated by the Cockcroft-Gault formula;\n   3. Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram.\n6. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g., intrauterine device, hormonal contraception, or condom use) during the study and for 6 months after the last dose of study drug. Male subjects whose partners are of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 6 months after the last dose of study drug.\n7. Willing and able to provide written informed consent and comply with the study follow-up requirements.\n\nExclusion Criteria:\n\n1. Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.\n2. Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.\n3. History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by PAP smear.\n4. Prior treatment with investigational drugs.\n5. Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.\n6. Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg\u002Fday prednisone or equivalent).\n7. History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or premedication agents.\n8. Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection with both HBV and HCV; Pregnant or breastfeeding women; subjects of childbearing potential unwilling or unable to use effective contraception; Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).\n9. Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol.\n10. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":440,"type":23},37,[26],"This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.",[444],"Mantle Cell Lymphoma",{"date":365,"type":38},{"date":447,"type":38},"2025-12-20",{"date":449,"type":23},"2029-07-31",{"name":44,"class":45},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":46},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860","NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.",{"count":459,"type":23},20,[107,26],"The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[463,464,465,466,467,468],"DLBCL","CLL","FL","MCL","WM","MZL",{"date":365,"type":38},{"date":471,"type":38},"2025-11-29",{"date":473,"type":23},"2029-11-28",{"name":44,"class":45},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":201,"enrollmentInfo":483,"targetDuration":4,"studyType":24,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":46},"100564938","phase-2-efficacy-of-venetoclax-combined-with-intensive-chemotherapy-in-different-subgroups-of-aml-100564938","NCT06635681","Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML","Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial","DAV-AML-2024","Inclusion Criteria:\n\n1. Patients who meet AML according to WHO (2022) or AML and MDS\u002FAML defined by ICC standards.\n2. Age ≥14 years old, ≤ 60 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);\n   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);\n   3. Blood creatinine \\\u003C 2 times the upper limit of normal (same age);\n   4. Myocardial enzymes \\\u003C 2 times the upper limit of normal (same age);\n   5. Left ventricular ejection fraction \\&gt;50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\\&#39;s condition, if the patient\\&#39;s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\\&#39;s immediate family.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are excluded from the study:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with BCR-ABL fusion gene\n3. Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).\n4. Concurrent malignant tumors of other organs (those requiring treatment).\n5. Active heart disease, defined as one or more of the following:\n\n   1. A history of uncontrolled or symptomatic angina;\n   2. Myocardial infarction less than 6 months after enrollment;\n   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;\n   4. Uncontrolled or symptomatic congestive heart failure (\\> NYHA level 2);\n6. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n7. Those who were not considered suitable for inclusion by the researchers.",{"count":484,"type":23},380,[26],"Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.\n\nRetrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.\n\nSince AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.\n\nTherefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.",[207],{"date":365,"type":38},{"date":490,"type":38},"2024-09-29",{"date":492,"type":23},"2028-10-01",{"name":44,"class":45},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":24,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":46},"100563105","phase-1-venetoclax-in-combination-with-ivosidenib-and-azacitidine-for-newly-diagnosed-idh1-mutated-aml-100563105","NCT06611839","Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML","A Multicenter, Single-Arm Clinical Study of the Venetoclax, Ivosidenib, and Azacitidine Triple-Drug Regimen in the Treatment of Chemotherapy-eligible Adult Patients With IDH1-Mutated Acute Myeloid Leukemia.","IDH1-AML-2024","Inclusion Criteria:\n\n1. Patients who meet AML according to WHO (2022) or AML and MDS\u002FAML defined by ICC standards with IDH1 mutations detected by PCR or second-generation sequencing.\n2. Age ≥14 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);\n   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);\n   3. Blood creatinine \\&amp;lt; 2 times the upper limit of normal (same age);\n   4. Myocardial enzymes \\&amp;lt; 2 times the upper limit of normal (same age);\n   5. Left ventricular ejection fraction \\&amp;gt;50% by measure of echocardiogram (ECHO) Informed consent must be signed before the commencement of all specific study procedures, and is signed by the patient himself or his immediate family. Considering the patient\\&amp;#39;s condition, if the patient\\&amp;#39;s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\\&amp;#39;s immediate family.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are excluded from the study:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n   1. A history of uncontrolled or symptomatic angina;\n   2. Myocardial infarction less than 6 months after enrollment;\n   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;\n   4. Uncontrolled or symptomatic congestive heart failure (\\&amp;gt; NYHA level 2);\n7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n8. Those who were not considered suitable for inclusion by the researchers.",{"count":503,"type":23},23,[107,26],"Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg\u002Fm²\u002Fday for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.",[250,507,508],"IDH1 Mutation","Treatment",{"date":365,"type":38},{"date":511,"type":38},"2025-10-17",{"date":492,"type":23},{"name":44,"class":45},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":24,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":46},"100559265","phase-1-the-efficacy-of-triple-regimen-in-newly-diagnosed-aml-patients-with-flt3-mutation-100559265","NCT06561880","The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation","The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation","FLT3AML-2024","Inclusion Criteria:\n\n1. MDS\u002FAML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.\n2. Age ≥15 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :\n\n1\\) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine \\\u003C 2 times the upper limit of normal (same age); 4) Myocardial enzymes \\\u003C 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n1\\) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.",{"count":523,"type":23},66,[107,26],"The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.",[527,250],"FLT3 Gene Mutation",{"date":365,"type":38},{"date":530,"type":38},"2024-10-08",{"date":532,"type":23},"2027-08-31",{"name":44,"class":45},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":541,"targetDuration":4,"studyType":24,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":550,"leadSponsor":551,"locationsCount":4},"100639831","phase-1-iaso206-in-patients-with-relapsedrefractory-autoimmune-hemolytic-anemia-100639831","NCT07585071","IASO206 in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Phase I Clinical Study on the Safety and Tolerability of IASO206 Injection in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age 18 to 75 years, gender unrestricted.\n* Diagnosis of AIHA (including warm antibody type, warm-cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with Chinese Expert Consensus on Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), 2019 International Consensus for Diagnosis and Management of Autoimmune Hemolytic Anemia (Blood Rev, 2020), or Chinese Expert Consensus on Diagnosis and Treatment of Evans Syndrome (2024 Edition).\n* Patients with relapsed\u002Frefractory disease after multiple lines of therapy must meet all of the following criteria: hemoglobin \\\u003C 10 g\u002FdL with clinical manifestations of hemolytic anemia; prior treatment with at least 2 immunosuppressive drugs (must include CD20 monoclonal antibody); glucocorticoid therapy for at least 3 months (excluded are patients with contraindications to glucocorticoids, severe infection, severe osteoporosis, previous fracture, or inability to tolerate glucocorticoids); cumulative dose of CD20 monoclonal antibody at least 375 mg\u002Fm² × 4, or total dose 2.0 g, or at least 6 administrations (at least 1 week apart each time).\n* ECOG score ≤ 2.\n* Expected survival time ≥ 12 weeks.\n* Adequate organ function confirmed by laboratory tests: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); minimum pulmonary reserve defined as grade ≤ 1 dyspnea and oxygen saturation ≥ 93% without oxygen supplementation; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL\u002Fmin; cardiac ejection fraction ≥ 50%, no pericardial effusion on echocardiogram (ECHO), and no clinically significant abnormal electrocardiogram (ECG).\n* Subjects and their partners agree to use effective barrier or medical contraceptive measures (excluding rhythm method) from signing informed consent until 1 year after administration.\n* Subjects must provide written informed consent approved by the Ethics Committee prior to initiation of screening procedures\n\nExclusion Criteria:\n\n* Subject with confirmed lymphoproliferative neoplasms.\n* Subject with secondary AIHA induced by drugs or infection.\n* Subject with congenital immunodeficiency diseases, other hereditary or acquired hemolytic diseases.\n* Subject with a history of organ or stem cell transplantation.\n* Subject with a history of organ infarction within the past 6 months.\n* Subject who have received prior BCMA-targeted therapy.\n* Subject who received plasma cell-targeted cell therapy within 3 months before screening, or in whom prior cell therapy products are still detectable in peripheral blood.\n* Subject who received any of the following treatments within the specified periods prior to study enrollment:\n\n  1. Anti-CD20 monoclonal antibody \\\u003C 12 weeks;\n  2. Sutimlimab or other marketed biological products \\\u003C 5 half-lives;\n  3. Plasma exchange \\\u003C 4 weeks;\n  4. Splenectomy \\\u003C 12 weeks.\n* Subject with any of the following cardiovascular diseases:\n\n  1. Left ventricular ejection fraction (LVEF) ≤ 45%;\n  2. Active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV);\n  3. Severe arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia);\n  4. QTcB interval ≥ 450 ms for males, ≥ 470 ms for females;\n  5. Myocardial infarction, bypass surgery, or stent implantation within 6 months before study;\n  6. Other cardiac diseases judged by the investigator to be unsuitable for enrollment.\n* Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic or renal diseases requiring medical treatment.\n* Subject with a history of other primary malignancies within 5 years before screening, except:\n\n  1. Resected and cured non-melanoma skin cancer (e.g., basal cell carcinoma);\n  2. Cured carcinoma in situ (e.g., cervical, bladder, or breast cancer);\n  3. Other primary cancers with no evidence of recurrence for more than 5 years after treatment.\n* Subject who underwent major surgery within 4 weeks before screening and are judged unsuitable for enrollment by the investigator.\n* Subject with uncontrolled active fungal, viral, bacterial, mycobacterial, or other infections (persistent infection-related signs\u002Fsymptoms without improvement after appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.\n* Positive hepatitis B surface antigen (HBs-Ag) or hepatitis B e antigen (HBe-Ag); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; active syphilis infection (excluding those with only positive syphilis-specific antibody).\n* Subject who received live viral vaccines within 4 weeks before enrollment.\n* Subject who are participating in other interventional clinical studies during IASO206 Injection treatment with a drug half-life \\\u003C 5; subject receiving active investigational drugs during the entire study period, or who intend to participate in another clinical trial, or receive treatments outside the protocol.\n* Pregnant or lactating females.\n* Subject with psychiatric disorders, disturbance of consciousness, or central nervous system diseases, including but not limited to epilepsy and Parkinson's disease.\n* Subject with hypersensitivity to components of IASO206 Injection or supportive medications required for the management of CAR-T therapy-related toxicities (e.g., tocilizumab).\n* Other conditions judged by the investigator to be unsuitable for enrollment.10. Other Information",{"count":85,"type":23},[107],"This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection (In Vivo CAR-T) in Patients with Relapsed\u002FRefractory Autoimmune Hemolytic Anemia",[545,546],"Autoimmune Hemolytic Anemia","Relapsed\u002FRefractory","2026-05-06",{"date":365,"type":38},{"date":144,"type":23},{"date":281,"type":23},{"name":44,"class":45},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":563,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":46},"100639998","brain-cognitive-network-abnormalities-in-anemia-patients-using-fnirs-100639998","NCT07578675","Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS","Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)","AN-CNA","Inclusion Criteria:\n\n* Diagnosis of anemia\n* First hospitalization\n* Male or female, aged 18-65 years\n* Willing and able to comply with the requirements for this study and written informed consent\n\nExclusion Criteria:\n\n* History of psychiatric illness\n* History of severe brain disease\n* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study","65 Years",{"count":562,"type":23},323,"OBSERVATIONAL","Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression.\n\nFunctional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.",[566,567,545,568],"Aplastic Anemia","Myelodysplastic Syndromes","Functional Near-Infrared Spectroscopy","2026-05-05",{"date":571,"type":38},"2026-05-11",{"date":573,"type":38},"2025-10-11",{"date":281,"type":23},{"name":44,"class":45},""]