[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Donghua Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":161},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,60,81,101,121,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100621907","a-clinical-study-evaluating-the-safety-and-efficacy-of-bcma-gprc5d-car-t-in-patients-with-relapsedrefractory-multiple-myeloma-who-have-received-three-or-more-lines-of-treatment-100621907",false,"NCT07376720","A Clinical Study Evaluating the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed\u002FRefractory Multiple Myeloma Who Have Received Three or More Lines of Treatment","Inclusion Criteria:\n\n1. The patient or their guardian understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examinations and treatments of the research procedures;\n2. Age 18-75 years (inclusive), gender not limited;\n3. According to the IMWG diagnostic criteria, patients diagnosed with multiple myeloma;\n4. Based on any of the following criteria, measurable lesions are determined during the screening: the level of single-clonal paraprotein (M-protein) in the blood ≥ 1.0 g\u002FdL or the M-protein level in urine ≥ 200 mg\u002F24 hours; or a light chain-type multiple myeloma diagnosed as having no measurable lesions in serum or urine: the free light chain of serum immunoglobulin ≥ 10 mg\u002FdL and the abnormal ratio of free light chains of serum immunoglobulin κ\u002Fγ;\n5. Has received at least three lines of treatment for multiple myeloma in the past, and should include:\n\n   1. One proteasome inhibitor (such as bortezomib, carfilzomib, ixazomib, etc.);\n   2. One immunomodulator (such as thalidomide, lenalidomide, pomalidomide, etc.);\n   3. One CD38 monoclonal antibody;\n6. There is evidence that the patient's multiple myeloma disease is relapsed\u002Frefractory or primary refractory, defined as:\n\n   1. Relapsed\u002Frefractory: no response to salvage therapy (no response is defined as not achieving minimal response \\[MR\\] or disease progression during treatment), or disease progression within 60 days after the last treatment, or disease progression after achieving MR or the above remission;\n   2. Primary refractory: no MR or above treatment response has been achieved, including patients who have never achieved MR or above remission, but the M-protein has not changed significantly and there is no clinical progression evidence, and patients with primary refractory and progression, meeting the progression definition.\n7. The patient has recovered from the toxicity of previous treatment, that is, the CTCAE toxicity grade is less than 2 (unless the abnormality is related to the tumor or is judged by the investigator to be in a stable state, which has little impact on safety or efficacy);\n8. The ECOG performance status score is 0-2 and the estimated survival period is more than 3 months;\n9. Has appropriate organ function:\n\n   1. Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal value (ULN);\n   2. Aspartate aminotransferase (AST) ≤ 3 times ULN;\n   3. Total bilirubin ≤ 1.5 times ULN;\n   4. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin;\n   5. Hemoglobin ≥ 50g\u002FL (must not have received blood transfusion support within 7 days before laboratory examination);\n   6. Intraocular oxygen saturation ≥ 92%;\n   7. Corrected serum calcium ≤ 12.5 mg\u002FdL (≤ 3.1 mmol\u002FL) or free ionized calcium ≤ 6.5 mg\u002FdL (≤ 1.6 mmol\u002FL);\n   8. Left ventricular ejection fraction (LVEF) ≥ 45%, confirmed by echocardiography that there is no pericardial effusion, and no clinically significant electrocardiogram findings;\n   9. No clinically significant pleural effusion;\n10. The required venous access can be established, and there are no contraindications for white blood cell collection.\n\nExclusion Criteria:\n\n1. Within 3 years, diagnosed with or treated for any other aggressive malignant tumor other than multiple myeloma;\n2. Previously received the following anti-tumor treatments (before collecting and preparing the CAR-T cells): within 14 days or at least 5 half-lives (whichever is shorter) received targeted therapy, epigenetic therapy or experimental drug treatment, or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulatory agent treatment within 7 days; received radiotherapy within 14 days (except for fields covering ≤5% of bone marrow reserves);\n3. Suspected that MM has involved the central nervous system or meninges and confirmed by MRI or CT, or has other active central nervous system diseases;\n4. At the screening stage, had Waldenström macroglobulinemia, POEMS syndrome (multiple neuropathy, organ enlargement, endocrine lesion, monoclonal protein disease and skin changes) or primary AL amyloidosis;\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer is higher than the lower limit set by the research institution; positive for hepatitis C virus (HCV) antibody and positive for peripheral blood HCV-RNA; positive for human immunodeficiency virus (HIV) antibody; quantitative detection of cytomegalovirus (CMV) DNA is higher than the lower limit set by the research institution; positive for syphilis spirochete antibody; quantitative detection of Epstein-Barr virus (EBV) DNA is higher than the lower limit set by the research institution;\n6. Those with a history of severe allergic reactions \\[severe allergic reactions are defined as secondary or higher-level allergic reactions, and when allergic reactions occur, any of the following clinical manifestations occur: airway obstruction (runny nose, cough, wheezing, breathing difficulty), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence of urine and stool, laryngeal edema, bronchospasm, cyanosis, shock, cardiac and respiratory arrest) or known to be sensitive to any active ingredients of the drugs included in this test, excipients, or murine products, or cross-reactive proteins from different species;\n7. Suffering from severe heart diseases, including but not limited to severe arrhythmia, unstable angina pectoris,大面积 myocardial infarction， NYHA class III or IV cardiac insufficiency before screening， having had a myocardial infarction within ≤ 6 months before screening or having received coronary artery bypass grafting (CABG)， having a history of unexplained syncope not caused by vasovagal or dehydration， severe non-ischemic cardiomyopathy history， refractory hypertension (refractory hypertension is defined as： after improving lifestyle， using reasonable and tolerable sufficient ≥ 3 types of antihypertensive drugs (including diuretics) for more than 1 month， blood pressure still cannot be controlled or taking ≥ 4 types of antihypertensive drugs can effectively control blood pressure)；\n8. Systemic diseases judged by the investigator to be unstable： including but not limited to severe liver， kidney or metabolic diseases requiring drug treatment；\n9. Had acute\u002Fchronic graft-versus-host disease (GVHD) within 6 months before screening， or patients requiring immunosuppressive therapy for GVHD；\n10. Patients with active autoimmune or inflammatory diseases of the nervous system (such as Guillain-Barré syndrome (GBS)， amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (such as brain edema， posterior reversible encephalopathy syndrome (PRES))；\n11. Those with tumor emergencies (such as spinal cord compression， intestinal obstruction， leukocyte stasis， tumor dissolution syndrome， etc.) requiring emergency treatment before screening or during reinfusion；\n12. Have infections that require antibiotic treatment， such as uncontrolled bacterial， fungal， viral or other infections；\n13. Within 1 week before blood collection for CAR-T preparation， have used drugs that affect the patient's blood count.\n\n    Short-acting hematopoietic cytokine drugs, or those who have used long-acting hematopoietic cytokine drugs within 2 weeks and whose preparation has been affected by the study investigators.\n14. During the screening, within 2 weeks before the planned preparation of CAR-T cells, those who are currently receiving hormones or immunosuppressive drugs, and whose preparation is judged to be affected by the study investigators:\n\n    1. Hormones: Those who are currently receiving systemic steroid therapy and whose treatment requires long-term systemic steroid therapy during the treatment period (except for inhalation or local use); and those who received systemic steroid therapy within 72 hours before the cell infusion (except for inhalation or local use);\n    2. Immunosuppressants: Those who are currently receiving immunosuppressants;\n15. Within 4 weeks before the conditioning regimen, those who have undergone major surgery (except diagnostic surgery and biopsy) or those whose major surgery is planned during the study period, or those whose surgical wounds have not fully healed before enrollment;\n16. Within 4 weeks before the screening, those who have received (attenuated) live virus vaccines;\n17. Those with severe mental disorders;\n18. Those who are heavy drinkers or have a history of drug abuse;\n19. Pregnant or lactating women, and female subjects who plan to conceive within 2 years after the cell infusion or whose male partners plan to conceive within 2 years after the cell infusion;","ALL","18 Years","78 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"NA","This research project includes patients with relapsed\u002Frefractory multiple myeloma (r\u002Fr MM) who have received more than three lines of treatment, including those with secondary recurrence, SCT recurrence, and refractory cases. Through this study, we aim to preliminarily determine the effectiveness of the treatment for r\u002Fr MM, with the expectation of providing new treatment methods to improve the survival rate of patients with r\u002Fr MM.",[26],"Multiple Myeloma","NOT_YET_RECRUITING","2026-01-21",{"date":30,"type":31},"2026-01-29","ACTUAL",{"date":33,"type":20},"2026-02-15",{"date":35,"type":20},"2029-10-30",{"name":37,"class":38},"Donghua Zhang","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":39},"100619527","clinical-study-on-the-safety-and-efficacy-of-cd7-targeted-chimeric-antigen-receptor-car-gene-modified-t-cells-for-the-treatment-of-cd7-positive-hematological-malignancies-100619527","NCT07345780","Clinical Study on the Safety and Efficacy of CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies","This Study is a Single-arm, Multicenter Investigator-Initiated Trial (IIT) Clinical Study. The Primary Objective is to Evaluate the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of CAR-T Cells in Subjects With Relapsed\u002FRefractory (r\u002Fr) CD7-positive Hematological Malignancies. The Study Plans to Enroll 20 Subjects, With the Actual Sample Size to be Determined Based on Real-world Occurrence.","Inclusion Criteria:\n\n* Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.\n\nAged 18-85 years (inclusive), gender not restricted. Subjects diagnosed according to WHO 2016 criteria with relapsed\u002Frefractory acute T-lymphoblastic leukemia\u002Flymphoma (including early T-precursor lymphoblastic leukemia) who have failed standard treatment or lack effective treatment options, meeting any of the following criteria:a) Relapsed: Previously received at least two treatment regimens and achieved complete remission followed by confirmed disease recurrence, or achieved complete remission after stem cell transplantation followed by disease recurrence.b) Refractory: Previously received at least two treatment regimens and failed to achieve CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to achieve remission or experienced disease progression after stem cell transplantation.\n\nDiagnosed with AML according to the 2016 WHO classification and meeting the diagnostic criteria for relapsed and refractory AML in the Chinese Guidelines for Diagnosis and Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia (2017 Edition):a) Diagnostic criteria for relapsed AML: Reappearance of leukemic cells in peripheral blood after complete remission (CR), or \\>5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary leukemic cell infiltration.b) Diagnostic criteria for refractory AML: Newly diagnosed cases failing to respond to standard treatment after 2 courses; Relapse within 12 months after CR following consolidation\u002Fintensification therapy; Relapse after 12 months but unresponsive to conventional chemotherapy; Two or more relapses; Persistent extramedullary leukemia.\n\nHematolymphoid malignancies confirmed by flow cytometry in bone marrow examination and\u002For by pathological immunohistochemistry in tumor tissue as CD7-positive at screening, with tumor positivity rate ≥70%.\n\nPatients who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT) must have the ability to donate autologous mononuclear cells (hereinafter referred to as apheresis) or peripheral blood for CAR-T cell manufacturing. Peripheral blood smear at screening should show \\\u003C30% tumor cells. For patients who have received allo-HSCT requiring autologous blood collection, peripheral blood smear at screening should also show \\\u003C30% tumor cells; there is no such restriction if collecting donor blood.\n\nPatients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade \\\u003C2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).\n\nECOG performance status score 0-2 and life expectancy \\>3 months.\n\nAppropriate organ function:\n\nAlanine transaminase (ALT) and aspartate transaminase (AST) ≤3×upper limit of normal (ULN). For ALT and AST abnormalities judged by the investigator to be disease-related (e.g., liver infiltration or biliary obstruction), the limit may be extended to ≤5×ULN.\n\nTotal bilirubin ≤1.5×ULN. Serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin. Hemoglobin ≥60 g\u002FL or maintained at this level after transfusion. Room air oxygen saturation ≥92%. Left ventricular ejection fraction (LVEF) ≥45%. Patients failing to meet any of the above criteria will not be enrolled as subjects.\n\nExclusion Criteria:\n\n* History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.\n\nPatients with clinically symptomatic central nervous system leukemia. Positive for hepatitis B surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with HBV DNA titer outside the normal reference range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.\n\nHistory of severe allergies \\[severe allergy defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest\\] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimens).\n\nSevere heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (defined as: blood pressure not controlled despite ≥3 antihypertensive drugs (including diuretics) at maximum tolerated doses for \\>1 month after lifestyle modification, or requiring ≥4 antihypertensive drugs for effective control).\n\nUnstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.\n\nPrevious organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).\n\nAcute or chronic graft-versus-host disease (GVHD) of any grade occurring 2 weeks after discontinuation of immunosuppressive therapy.\n\nHematopoietic stem cell transplantation within 6 months prior to screening. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).\n\nTumor emergencies requiring urgent treatment at screening or prior to infusion (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).\n\nUncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment.\n\nMajor surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds prior to enrollment.\n\nLive virus vaccination within 4 weeks prior to screening. Severe mental illness. History of alcoholism or substance abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.\n\nPatients with contraindications to any study procedures or other medical conditions that may put them at unacceptable risk according to investigator judgment and\u002For clinical standards.",{"count":19,"type":20},[23],"This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed\u002Frefractory (r\u002Fr) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.",[51],"CD7-Positive Hematological Malignancies","2026-01-07",{"date":54,"type":31},"2026-01-16",{"date":56,"type":20},"2026-12-31",{"date":58,"type":20},"2029-12-31",{"name":37,"class":38},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":39},"100619523","clinical-study-evaluating-the-safety-and-efficacy-of-baffr-car-t-therapy-for-relapsedrefractory-b-cell-malignancies-100619523","NCT07345728","Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed\u002FRefractory B-cell Malignancies","A Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\nPatients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatment procedures of the study; Age 18-85 years (inclusive), gender not restricted; Patients with relapsed\u002Frefractory B-cell lymphoma who have received prior treatment including anti-CD20 targeted agents (unless documented CD20 negative) and anthracycline-containing regimens; Pathological immunohistochemistry of tumor confirms positive BAFFR target expression at screening; Patients have recovered from the toxicities of previous treatments, i.e., CTCAE toxicity grade \\\u003C 2 (unless abnormalities are tumor-related or judged by the investigator to be stable and not significantly affecting safety or efficacy); ECOG performance status 0-2 and life expectancy \\> 3 months;\n\nAdequate organ function:\n\n1. Alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN);\n2. Aspartate transaminase (AST) ≤ 3 × ULN;\n3. Total bilirubin ≤ 1.5 × ULN;\n4. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n5. Hemoglobin ≥ 60 g\u002FL or maintained at this level after transfusion;\n6. Room air oxygen saturation ≥ 92%;\n7. Left ventricular ejection fraction (LVEF) ≥ 45%; Accessible venous access for apheresis and no contraindications to leukapheresis.\n\nExclusion Criteria:History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid cancer, basal or squamous cell skin cancer, localized prostate cancer after radical therapy, and ductal carcinoma in situ after radical therapy; Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV-RNA; positive for human immunodeficiency virus (HIV) antibody; History of severe allergies \\[severe allergy is defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest\\] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimen); History of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after \\> 1 month of treatment with reasonable, tolerable, and adequate doses of ≥ 3 antihypertensive drugs (including diuretics), or requires ≥ 4 antihypertensive drugs to achieve effective blood pressure control); Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment; Previous organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation); Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); Presence of tumor emergencies (e.g., spinal cord compression, bowel obstruction, leukostasis, tumor lysis syndrome, etc.) requiring urgent treatment at screening or before infusion; Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment; Use of short-acting hematopoietic growth factors affecting blood counts within 1 week, or long-acting hematopoietic growth factors within 2 weeks prior to planned CAR-T manufacturing apheresis, and judged by the investigator to affect cell manufacturing;\n\nReceiving corticosteroids or immunosuppressive drugs within 2 weeks prior to planned CAR-T manufacturing apheresis, and judged by the investigator to affect cell manufacturing:\n\n1. Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned CAR-T manufacturing apheresis and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use);\n2. Immunosuppressants: Subjects receiving immunosuppressive agents within 2 weeks prior to planned CAR-T manufacturing apheresis; Major surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds before enrollment; Vaccination with (live-attenuated) viral vaccines within 4 weeks prior to screening; History of severe mental illness; History of alcoholism or substance abuse; Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion; Subjects with contraindications to any study procedures or other medical conditions that may pose unacceptable risks according to the investigator's judgment and\u002For clinical standards.",{"count":19,"type":20},[23],"This is a prospective, single-arm, multi-center, randomized controlled clinical study designed to evaluate the safety and efficacy of BAFFR CAR-T therapy for relapsed\u002Frefractory B-cell malignancies. A total of 30 subjects are planned to be enrolled.",[71],"Relapsed\u002FRefractory B-cell Malignancies",[73],"relapsed\u002Frefractory B-cell malignancies","RECRUITING",{"date":54,"type":31},{"date":77,"type":20},"2026-01-01",{"date":79,"type":20},"2029-06-01",{"name":37,"class":38},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":39},"100619255","safety-and-efficacy-of-cll1-car-t-followed-by-allogeneic-hematopoietic-stem-cell-transplantation-in-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100619255","NCT07342244","Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments as required by the study protocol.\n\nAge between 18-75 years (inclusive), gender not restricted. Confirmed diagnosis of acute myeloid leukemia (AML), with prior receipt of at least one course of systemic chemotherapy, and efficacy assessment showing relapse\u002Frefractory disease.\n\nFlow cytometry of bone marrow examination or immunohistochemistry of tumor pathology at screening confirms positive expression of CLL1 target.\n\nPatients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is tumor-related or judged by the investigator to be in a stable state with little impact on safety or efficacy).\n\nECOG performance status score 0-2 and expected survival time \\> 3 months. Adequate organ function:a) Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)b) Aspartate aminotransferase (AST) ≤ 3 × ULNc) Total bilirubin ≤ 1.5 × ULNd) Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmine) Hemoglobin ≥ 60 g\u002FL or maintained at this level after blood transfusionf) Indoor oxygen saturation ≥ 92%g) Left ventricular ejection fraction (LVEF) ≥ 45% Capable of establishing venous access required for apheresis, with no contraindications to leukapheresis.\n\nExclusion Criteria:\n\n* History of other malignancies within 3 years prior to screening, except for adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin carcinoma, locally treated prostate cancer after radical treatment, and ductal carcinoma in situ after radical treatment.\n\nDiagnosis of Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis at screening.\n\nPositive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with HBV DNA titer in peripheral blood above the lower limit of detection of the research institution; positive for hepatitis C virus (HCV) antibody with positive HCV-RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA quantitative test above the lower limit of detection of the research institution; positive for Treponema pallidum antibody; Epstein-Barr virus (EBV) DNA quantitative test above the lower limit of detection of the research institution.\n\nHistory of severe allergic reactions \\[severe allergic reaction is defined as grade 2 or higher allergic reaction, with any of the following clinical manifestations: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest\\] or known hypersensitivity to any active ingredients, excipients of the study drugs (including lymphodepletion regimen), murine products, or heterologous proteins.\n\nHistory of severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction or coronary artery bypass grafting (CABG) within ≤ 6 months prior to screening, history of unexplained syncope not due to vasovagal reaction or dehydration, history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: despite lifestyle modifications, blood pressure remains uncontrolled after \\>1 month of treatment with ≥3 antihypertensive drugs (including diuretics) at reasonable and tolerable maximum doses, or requires ≥4 antihypertensive drugs to effectively control blood pressure).\n\nUnstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring medical treatment.\n\nPrevious organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).\n\nPrevious receipt of CAR-T therapy. History of acute\u002Fchronic graft-versus-host disease (GVHD) within 6 months prior to screening, or patients requiring immunosuppressive therapy for GVHD.\n\nActive autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).\n\nPresence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring urgent treatment at screening or before infusion.\n\nUncontrolled bacterial, fungal, viral or other infections requiring antibiotic treatment.\n\nUse of short-acting hematopoietic cytokines affecting blood counts within 1 week prior to planned blood collection for CAR-T manufacturing, or use of long-acting hematopoietic cytokines within 2 weeks prior to screening, and judged by the investigator to have an impact on cell manufacturing.\n\nReceipt of corticosteroids or immunosuppressive drugs within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening, and judged by the investigator to have an impact on cell manufacturing:a) Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use).b) Immunosuppressants: Subjects receiving immunosuppressive therapy within 2 weeks prior to planned blood collection for CAR-T manufacturing at screening.\n\nMajor surgical procedures (except diagnostic surgery and biopsy) within 4 weeks prior to lymphodepletion or planned major surgery during the study period, or surgical wounds not fully healed before enrollment.\n\nVaccination with (attenuated) live viral vaccines within 4 weeks prior to screening.\n\nPresence of severe mental illness. History of alcoholism or drug abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.\n\nSubjects with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks, as judged by the investigator and\u002For according to clinical standards.",{"count":88,"type":20},18,[23],"This study aims to evaluate whether an innovative combination therapy (CLL1 CAR-T sequential allogeneic hematopoietic stem cell transplantation) is safe, feasible and effective for the treatment of relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML).",[92,93],"AML","AML (Acute Myeloid Leukemia)",{"date":95,"type":31},"2026-01-15",{"date":97,"type":20},"2026-01-30",{"date":99,"type":20},"2029-12-20",{"name":37,"class":38},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":39},"100619524","clinical-study-on-the-safety-and-efficacy-of-cd20cd19-cell-injection-in-the-treatment-of-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-100619524","NCT07345741","Clinical Study on the Safety and Efficacy of CD20\u002FCD19 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nWritten informed consent: Signed written informed consent and ability to comply with protocol-specified visits and procedures.\n\nAge and life expectancy: Age ≥ 18 years with an expected survival of more than 3 months.\n\nPathological diagnosis: Histopathologically confirmed CD20+ relapsed or refractory B-cell non-Hodgkin lymphoma (according to WHO 2016 lymphoma classification), including but not limited to:\n\nDiffuse large B-cell lymphoma (DLBCL) High-grade B-cell lymphoma (HGBCL) Follicular lymphoma grade 3b (3b FL)\n\nRelapsed or refractory disease: Defined by meeting one or more of the following:\n\nRelapse, non-response, or progression after hematopoietic stem cell transplantation Stable disease for ≤ 6 months after at least two cycles of second-line therapy (DLBCL\u002FHGBCL\u002F3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) Disease progression or relapse after at least second-line therapy (DLBCL\u002FHGBCL\u002F3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) ECOG performance status: 0-2.\n\nContraception requirements:\n\nFertile males and females of childbearing potential must agree to use effective contraception from signing informed consent until 6 months after last study drug administration Negative serum pregnancy test required for females of childbearing potential at screening\n\nMeasurable disease: At least one measurable lesion according to Lugano 2014 criteria:\n\nLymph node lesions \\> 15mm in longest diameter on CT Extranodal lesions \\> 10mm in longest diameter FDG-PET positive (SUV ≥ 4 or 5) Radiated lesions only considered measurable if progression documented after completion of radiotherapy\n\nHematological parameters (no blood transfusion or hematopoietic growth factor within 7 days prior to testing):\n\nHemoglobin (Hb) ≥ 80 g\u002FL Absolute neutrophil count (ANC) ≥ 1×10⁹\u002FL Platelet count (PLT) ≥ 50×10⁹\u002FL\n\nCoagulation function:\n\nInternational Normalized Ratio (INR) ≤ 1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN (INR 2.0-3.0 acceptable for subjects on prophylactic anticoagulation)\n\nOrgan function requirements:\n\nRenal: Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula) Hepatic: Total bilirubin ≤ 1.5×ULN (≤ 3×ULN for liver infiltration or Gilbert's syndrome); ALT and AST ≤ 3×ULN (≤ 5×ULN for liver infiltration) Pulmonary: Oxygen saturation ≥ 92% on room air Subjects failing to meet any of the above criteria will not be eligible for enrollment.\n\nExclusion Criteria:\n\nPrimary CNS involvement: Primary central nervous system lymphoma or active CNS involvement\u002Fsymptoms.\n\nAutoimmune conditions: Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia) or uncontrolled pleural effusions.\n\nCardiovascular history:\n\nSevere cardiac rhythm\u002Fconduction abnormalities requiring intervention QTcF prolongation (\\> 450 ms males, \\> 470 ms females) Acute coronary syndrome, heart failure, aortic dissection, stroke, or other ≥ grade 3 cardiovascular events within 6 months NYHA class ≥ II heart failure or LVEF \\\u003C 50% Uncontrolled hypertension (systolic ≥ 160 mmHg and\u002For diastolic ≥ 100 mmHg despite medication)\n\nPrior cell therapies\u002Ftransplants:\n\nAutologous stem cell transplant or cell therapy within 3 months Allogeneic stem cell transplant or cell therapy within 6 months History of solid organ transplantation Prior anticancer therapy: Anticancer treatment or participation in other interventional clinical studies within 4 weeks or 5 half-lives (whichever is shorter) before lymphodepletion.\n\nRecent procedures\u002Fvaccinations: Live attenuated vaccine or major surgery within 4 weeks before lymphodepletion, or planned during study.\n\nSystemic steroids: Requirement for prolonged (≥ 3 days) systemic steroid therapy (≥ 10 mg\u002Fday prednisone equivalent) during study (inhaled or topical steroids excluded).\n\nOther malignancies\u002Fconditions: History of other malignancies (except cured in-situ cervical cancer, non-invasive skin cancers, or locally treated prostate\u002Fbreast carcinoma with ≥ 2 years remission); severe diabetes or other serious comorbidities.\n\nActive infections: Active fungal, bacterial, viral, or mycobacterial infections requiring systemic treatment within 14 days before lymphodepletion.\n\nInfectious diseases:\n\nHBsAg positive or HBcAb positive with detectable HBV DNA HCV antibody positive with detectable HCV RNA HIV antibody positive Active syphilis Hypersensitivity: Life-threatening hypersensitivity or intolerance to study medications or severe allergic diathesis.\n\nPregnancy\u002Flactation: Pregnant or breastfeeding females. Other factors: Any condition deemed by investigator to affect compliance or make subject unsuitable for study participation.",{"count":19,"type":20},[23],"Evaluate the safety and tolerability of AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL). To preliminarily determine the Maximum Tolerated Dose (MTD) or recommended clinical dose of AcNK-Sup003 cell injection.",[111,112],"R\u002FR B-NHL","Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (R\u002FR B-NHL)",[114],"relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL)",{"date":54,"type":31},{"date":117,"type":20},"2025-12-31",{"date":119,"type":20},"2030-12-31",{"name":37,"class":38},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":39},"100611180","clinical-study-to-evaluate-the-safety-and-efficacy-of--t-cells-for-the-prevention-of-relapse-after-allogeneic-transplantation-in-patients-with-high-risk-acute-myeloid-leukemia-100611180","NCT07237230","Clinical Study to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia","Clinical Study Protocol to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Voluntarily signs the informed consent form and is expected to be able to complete the follow-up examinations and treatments required by the study procedures.\n2. Age 18 to 65 years (inclusive), regardless of gender.\n3. Patients have one of the high-risk factors for relapse before allogeneic hematopoietic stem cell transplantation：①Meets the diagnostic criteria for relapsed or refractory disease as defined by the Chinese Guidelines for Diagnosis and Management of Relapsed\u002FRefractory Acute Myeloid Leukemia (2017 Edition);②Hyperleukocytosis (≥100×10⁹\u002FL) with concomitant central nervous system leukemia (CNSL); ③Positive minimal residual disease (MRD) before transplantation; ④Populations defined as having poor prognosis;⑤Myelodysplastic syndromes transformed to or secondary acute myeloid leukemia.\n4. Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation.\n5. The subject has recovered from toxicities of previous therapies, defined as CTCAE grade \\\u003C2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).\n6. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-3 and an estimated life expectancy greater than 3 months.\n7. Adequate organ function is defined as:\n\n   1. Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);\n   2. Aspartate aminotransferase (AST) ≤3 × ULN;\n   3. Total bilirubin ≤1.5 × ULN;\n   4. Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL\u002Fmin;\n   5. Hemoglobin ≥50g\u002FL (must not have received transfusion support within 7 days prior to laboratory testing);\n   6. Room air oxygen saturation ≥92%;\n   7. Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography without pericardial effusion and no clinically significant ECG findings;\n   8. No clinically significant pleural effusion.\n\nExclusion Criteria:\n\n1. Diagnosis of another malignancy within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery;\n2. History of severe allergy (defined as a grade 2 or higher allergic reaction manifested by any of the following: airway obstruction \\[rhinorrhea, cough, wheezing, dyspnea\\], tachycardia, hypotension, arrhythmia, gastrointestinal symptoms \\[nausea, vomiting\\], incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest) or known allergy to any active ingredient, excipient, murine-derived products, or xenogeneic proteins contained in the investigational product;\n3. Severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large-area myocardial infarction, New York Heart Association Class III or IV cardiac dysfunction, or refractory hypertension (defined as failure to achieve blood pressure control after \\>1 month of treatment with ≥3 tolerable antihypertensive drugs at optimal doses, including diuretics, or requiring ≥4 antihypertensive drugs for effective control);\n4. Severe respiratory disease (including history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm);\n5. Presence of grade III-IV acute GVHD(Graft-Versus-Host Disease) or extensive chronic GVHD;\n6. Current use (or intention to use) other maintenance therapies post-hematopoietic stem cell transplantation that have been demonstrated to adversely affect the persistence of γδ T cells in vivo;\n7. Active neurological autoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome \\[GBS\\], amyotrophic lateral sclerosis \\[ALS\\]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]);\n8. Presence of severe psychiatric disorders;\n9. History of alcohol abuse or drug abuse;\n10. Clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]);\n11. Participation in another clinical study within 1 month prior to screening, unless deemed by the investigator as non-interfering with the safety and efficacy evaluation of the investigational product (e.g., non-interventional observational studies);\n12. Women who are pregnant or breastfeeding, female subjects planning pregnancy within 1 year after cell infusion, or male subjects with partners planning pregnancy within 1 year after cell infusion;\n13. Patients with contraindications to any study procedure or other medical conditions that may pose unacceptable risks, as determined by the investigator's judgment and\u002For clinical standards.","65 Years",{"count":130,"type":20},40,[23],"This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation.",[134],"High-Risk Acute Myeloid Leukemia","2025-11-14",{"date":137,"type":31},"2025-11-19",{"date":139,"type":31},"2025-07-01",{"date":141,"type":20},"2028-07-01",{"name":37,"class":38},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":39},"100611157","clinical-study-of-selinexor-based-chemotherapy-with-minimal-or-no-cytotoxic-agents-in-treatment-nave-aml-patients-unsuitable-for-intensive-therapy-focusing-on-rapid-reduction-of-blast-cells-100611157","NCT07236931","Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells","Inclusion Criteria:\n\n1. Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.\n2. Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)\n3. Renal function must meet the following criterion: Creatinine clearance ≥30 mL\u002Fmin calculated using the Cockcroft-Gault formula.\n4. No history of drug allergies within the protocol.\n5. Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.\n6. The participant understands and signs the informed consent form.\n\nExclusion Criteria:\n\n1. A definitive diagnosis of Acute Promyelocytic Leukemia (APL).\n2. Age \\\u003C18 years or ≥75 years.\n3. The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.\n4. Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.\n5. Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.\n6. Patients who have other malignancies that require treatment.\n7. A history of allergy to the study drugs.\n8. Female participants who are pregnant or breastfeeding.\n9. Human immunodeficiency virus (HIV) infection or syphilis infection.\n10. Active hepatitis that remains uncontrolled despite active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid \\[HBV DNA\\] or hepatitis C virus ribonucleic acid \\[HCV RNA\\]).\n11. Patients with persistent positivity for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 (excluding those who have transitioned from positive to negative).\n12. Conditions that the investigator considers may increase the risk to participants or interfere with the study results.\n13. Other conditions that the investigator deems the participant unsuitable for enrollment in this study.","74 Years",{"count":151,"type":20},71,[23],"This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.",[93],{"date":137,"type":31},{"date":157,"type":20},"2025-11-20",{"date":159,"type":20},"2028-10-20",{"name":37,"class":38},""]