[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"car-t-cell-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:car-t-cell-therapy":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,44,69,90,136,157,182,205,234,260,278,304,330,354,383,407,418,442,466,491,514,536,570,594,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053673","neuroimaging-and-biomarkers-of-neurotoxicity-after-chimeric-antigen-receptor-t-cell-therapy-100053673",false,"NCT07075523","Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy","Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Age ≥ 18 years\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Patients recommended to undergo commercial chimeric antigen receptor T-cell therapy\n\nExclusion Criteria:\n\n* Contraindication for magnetic resonance imaging","ALL","18 Years",{"count":20,"type":21},36,"ESTIMATED","OBSERVATIONAL","The goal of this study is to understand why some people receiving chimeric antigen receptor (CAR) T-cell therapy for cancer experience neurotoxicity. The main question it aims to answer is:\n\nCan a novel tool be developed to identify early the patients who will develop immune effector cell-associated neurotoxicity syndrome (ICANS, also called neurotoxicity) after chimeric antigen receptor (CAR) T-cell therapy?\n\nParticipants already scheduled for chimeric antigen receptor (CAR) T-cell therapy as part of the medical care for their cancer will be evaluated with advanced neuroimaging techniques. In addition, neurocognitive assessments using questionnaires and measurement of biomarkers in blood (liquid biomarkers) will be performed to provide a comprehensive characterization of neurotoxicity following chimeric antigen receptor T-cell therapy.\n\nAssessments will be performed in the acute phase (2 to 14 days after chimeric antigen receptor (CAR) T-cell therapy) and after approximately 3 months.",[25],"CAR T-Cell Therapy",[27,28,29,30],"CAR T-cell therapy","RBANS","ICANS","Magnetic resonance imaging","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2025-09-19",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"University of California, San Diego","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100560328","coping-skills-training-for-symptom-management-and-daily-steps-step-up-100560328","NCT06575712","Coping Skills Training for Symptom Management and Daily Steps (Step Up)","Inclusion Criteria:\n\n* receipt of an autologous (auto) HCT or CAR-T cell therapy due to a hematologic malignancy, such as a diagnosis of leukemia, lymphoma, multiple myeloma\n* age \\>18\n* self-reported fatigue, pain, and psychological distress (confirmed at recruitment) - minimum two of three symptoms reported at \\>3 on 0-10 scale\n* life expectancy \\> 12 months\n\nExclusion Criteria:\n\n* cognitive impairment (e.g., dementia) recorded in the chart or suspected by provider\n* metastases to the brain\n* presence of a severe psychiatric condition (e.g., psychotic disorder) that would contraindicate safe participation as indicated by the medical chart, treating oncologist, or interactions with the medical\u002Fstudy staff\n* inability to converse in English","99 Years",{"count":52,"type":21},177,"INTERVENTIONAL",[55],"NA","The aim of this study is to test the efficacy of a hybrid in-person and mHealth coping skills training and activity coaching intervention (Step Up), to enable HCT patients to effectively cope with symptoms (pain, fatigue, and stress) to improve their ability to engage in physical activity that can improve physical disability.",[58,59],"Hematopoietic Stem Cell Transplant","CAR-T Cell Therapy","2026-06-24",{"date":62,"type":35},"2026-06-25",{"date":64,"type":35},"2025-04-21",{"date":66,"type":21},"2029-07-15",{"name":68,"class":42},"Duke University",{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},"100625555","long-term-follow-up-of-subjects-treated-with-seattle-childrens-therapeutics-gene-therapy-products-100625555","NCT07424157","Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products","LTFU-01","Inclusion Criteria:\n\n1. Enrolled in an SCTx GTP clinical trial;\n2. Received or planned to receive an SCTx GTP;\n3. Subject and\u002For legally authorized representative have provided consent\u002Fassent for study participation.",{"count":77,"type":21},500,"Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.",[80,81],"CAR T Cell","CAR T Cell Therapy","2026-06-23",{"date":62,"type":35},{"date":85,"type":35},"2026-06-15",{"date":87,"type":21},"2041-03-31",{"name":89,"class":42},"Seattle Children's Hospital",{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":53,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":43},"100565518","early-phase-1-exercise-as-an-immune-adjuvant-for-allogeneic-cell-therapies-100565518","NCT06643221","Exercise as an Immune Adjuvant for Allogeneic Cell Therapies","Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies","Allo-X","Procedures are in place for protecting against or minimizing the risks to the healthy volunteers recruited for this study. Physical risk to volunteers and matched related donors will be protected through health screening to determine study eligibility, and medical monitoring with an established test termination criterion during the exercise and isoproterenol infusion trials.\n\nTo protect against the remote risk of an adverse cardiac event occurring during exercise and isoproterenol infusion, the study will only enroll volunteers who are considered \"low risk\" for maximal stress testing in accordance with the guidelines published by the American College of Sports Medicine (ACSM) and American Heart Association (AHA). Individuals who are considered \"low risk\" are men and women who are asymptomatic and have no more than one risk factor for cardiovascular disease (CVD). The risks to subjects are therefore extremely low. All infusions will take place in the Clinical and Translational Sciences Research Center (CATS) Infusion Suite, which is a designated University of Arizona campus facility for infusion trials and equipped with appropriate medical personnel and monitoring equipment (i.e. ECG). The graded exercise tests and isoproterenol infusions procedures will be performed under the direction of a licensed and board-certified cardiologist\n\nInclusion Criteria:\n\nParticipants must:\n\n* Be between 21 and 55 years of age.\n* Be classified as 'low-risk' for graded exercise\u002Fstress testing according to ACSM-AHA criteria.\n* Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Currently use tobacco products or have quit within the last 6 months.\n* Have a body mass index (BMI) greater than 34 kg\u002Fm² or waist circumference exceeding 102 cm for men and 88 cm for women.\n* Use any medications known to affect the immune system or regularly take ibuprofen\u002Faspirin, antidepressants, or medications that alter blood pressure or cardiovascular function.\n* Use of hormone replacement therapy.\n* Are pregnant or breastfeeding.\n* Have chronic or debilitating arthritis or have been bedridden in the past three months.\n* Experienced a common illness (e.g., colds) within the past 6 weeks.\n* Have central or peripheral nervous disorders, a history of stroke, or major affective disorder.\n* Are infected with HIV or hepatitis or have any autoimmune disease.\n* Have known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast.\n* Use any prescription medications or have an allergy to beta-blockers.\n* Have a resting heart rate of less than 50 beats per minute.\n* Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions.\n* Are scheduled for surgery.\n\nAdditionally, participants who meet the inclusion criteria but present with more than one of the following cardiovascular disease (CVD) risk factors will be excluded unless cleared by a cardiologist:\n\n* Family History: Myocardial infarction, coronary revascularization, or sudden death before 55 years of age in a father or male first-degree relative, or before 65 years of age in a mother or female first-degree relative.\n* Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg.\n* Dyslipidemia: Total serum cholesterol exceeding 200 mg\u002Fdl.\n* Pre-diabetes: Fasting blood glucose levels between 100 mg\u002Fdl and 126 mg\u002Fdl.",true,"21 Years","55 Years",{"count":102,"type":21},200,[104],"EARLY_PHASE1","This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue.\n\nThis Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups:\n\n1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice.\n2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells.\n3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise.\n\nParticipants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.",[107,108,109,25,110,111],"Leukemia","Hematopoetic Stem Cell Transplantation","Donor Lymphocyte Infusion","Lymphoma","Cell Therapy",[113,114,115,116,117,118,119,120,121,122,123,124,125,126],"exercise","cell therapy","beta-blockers","immune function","phosphodiesterase inhibitor","CAR T-cells","NK-cells","cytokine-induced killer cells","cytokine-induced memory-like NK-cells","monoclonal antibodies","leukemia","lymphoma","donor lymphocyte infusion","gamma-delta T-cells","2026-06-03",{"date":129,"type":35},"2026-06-05",{"date":131,"type":35},"2018-01-24",{"date":133,"type":21},"2031-05-31",{"name":135,"class":42},"University of Arizona",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":53,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":43},"100505232","early-phase-1-dual-target-car-t-cell-treatment-for-refractory-systemic-lupus-erythematosus-sle-patients-100505232","NCT05858684","Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients","Inclusion Criteria:\n\n1. 18-70 years old;\n2. Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria;\n3. LLDAS response criteria are not achieved after administration with at least two immunosuppressants (including, but not limited to, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, ciclosporin and iguratimod) and\u002For at least one approved biological agent for more than 6 months.\n4. SELENA-SLEDAI≥8;\n5. Patients with CD19+ B-cell;\n6. Hemoglobin≥85 g\u002FL;\n7. WBC≥2.5×10\\^9\u002FL\n8. NEUT≥1×10\\^9\u002FL;\n9. BPC≥50×10\\^9\u002FL;\n10. AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%;\n11. Adequate venous access for apheresis, and no other contraindications for leukapheresis;\n12. Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline. Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n13. Agree to attend follow-up visits as required;\n14. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative;\n\nExclusion Criteria:\n\n1. Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks prior to leukapheresis, or subjects who need hemodialysis;\n2. CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts;\n3. Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system;\n4. Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n5. Received immunosuppressive therapy within 1 week prior to leukapheresis;\n6. Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus; Patients with syphilis infection;\n7. The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening;\n8. Received live vaccine treatment within 4 weeks prior to screening;\n9. Severe allergies or hypersensitivity;\n10. Contraindication to cyclophosphamide in combination with fludarabine;\n11. Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion;\n12. cannula or drainage tubes other than central venous catheters;\n13. Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n14. Subjects with prior CD19 or BCMA-targeted therapy\n15. Participated in any clinical study within 3 months prior to enrollment\n16. Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer;\n17. Any situations that the investigator believes the patients are not suitable for the study.","70 Years",{"count":144,"type":21},18,[104],"This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.",[59],"2026-05-29",{"date":150,"type":35},"2026-06-01",{"date":152,"type":35},"2023-05-11",{"date":154,"type":21},"2029-06-10",{"name":156,"class":42},"RenJi Hospital",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":164,"targetDuration":4,"studyType":53,"phases":166,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":43},"100606659","phase-1-mb-cart20191-in-refractory-multiple-sclerosis-100606659","NCT07178431","MB-CART2019.1 in Refractory Multiple Sclerosis","An Open Label Phase I\u002FIIa, Multicenter, Interventional Single-arm Trial of MB-CART 2019.1 in Patients With Refractory Multiple Sclerosis (MS)","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be included in the trial:\n\n1. Have read, understood and signed\u002Fdated the informed consent form.\n2. Age ≥18 years at the time of screening.\n3. Diagnosis of multiple sclerosis fulfilling the 2017 McDonald criteria.\n4. Progressive or worsening MS according to 2014 Lublin MS phenotypic criteria\n5. Disease activity despite treatment:\n\n   1. Definition for RRMS\u002FSPMS:\n\n      1 or more relapses or an EDSS deterioration in the previous year (1 point or more if EDSS is between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new\u002Fenlarging T2 lesions or T1CE lesions) despite on\u002Fprevious treatment with an escalation therapy drug (i.e. natalizumab, ofatumumab, ocrelizumab, alemtuzumab or mitoxantrone) for at least 6 months.\n   2. Definition for PPMS:\n\n      EDSS deterioration in the previous year (1 point or more if EDSS between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new\u002Fenlarging T2 lesions or T1CE lesions) despite on\u002Fprevious treatment with ocrelizumab (treatment duration ≥ 6 months).\n   3. Evidence of intrathecal IgG production through oligoclonal bands (OCBs) present in the cerebrospinal fluid in PPMS or SPMS.\n6. Fully vaccinated against Hepatitis B.\n7. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of varicella zoster glycoprotein E Shingrix vaccine at least 4 weeks prior to treatment.\n8. Presence of anti EBV antibodies\n9. Organ function \u002F lab parameters as follows\n\n   1. Absolute Neutrophil count \\> 2000\u002FuL\n   2. Platelets \\> 150,000\u002FuL\n   3. Absolute Lymphocyte count \\> 1000\u002FuL\n   4. Serum IgG \\> 500 mg\u002Fdl\n   5. Hemoglobin \\> 9g\u002Fdl\n10. Adequate renal, hepatic, pulmonary and cardiac function defined as\n\n    1. Creatinine ,\\\u003C 2mg\u002Fdl or creatinine clearance \\> to 60ml\u002Fmin\n    2. ALT\u002FAST \\\u003C 3x ULN\n    3. Total bilirubin \\\u003C 1,5 mg\u002Fdl, except for subjects with Gilbert syndrome.\n    4. Cardiac ejection fraction \\> 40%, no evidence of significant pericardial effusion (echography) or clinically significant ECG findings\n    5. Baseline oxygen saturation \\> 94% on air room\n11. Negative test for Hepatitis B core antibody and Hepatitis C core antibody, CMV, VZ, Herpes simplex virus 1 and 2 ab\n12. Negative test for Myelin-Oligodendrocyte-Glycoprotein (MOG) and Aquaporin-4 (AQP-4) autoantibodies\n13. Women of childbearing potential (WOCBP) must be able and willing to use at least one highly effective method of contraception from the time of consent until 12 months after the administration of MB-CART2019.1. WOCBP must refrain from donating eggs during the same period. A woman is considered of childbearing potential, i.e., fertile, following menarche and until having been postmenopausal for at least 12 months or unless otherwise permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the definition and a list of highly effective methods of contraception, see Appendix 1 Contraception Guidelines.\n14. Men whose sexual partners are WOCBP must be able and willing to use at least one highly effective method of contraception (used by themselves or their female partners; see Appendix 1 Contraception Guidelines) from the time of consent until 12 months after the administration of MB-CART2019.1.\n15. Willingness and ability to comply with all trial procedures.\n16. Adequate vital signs.\n\nExclusion Criteria:\n\nPatients will be entered into this trial only if they meet none of the following criteria:\n\n1. For relapsing and progressive MS forms: the disability status according to the EDSS scale is larger than 7.0 or the age is larger than 55 years.\n\n   Only applicable for progressive MS (PPMS\u002FSPMS), where the disease duration is longer than 15 years.\n2. History of a malignancy unless disease free for ≥5 years with the exception of basal or squamous cell skin cancer\n3. Known history of and\u002For active infection with hepatitis B (hepatitis B surface antigen positive)\n4. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative\n5. Any active uncontrolled bacterial, viral or fungal infection\n6. A history of and\u002For active infection with human immunodeficiency virus (HIV)\n7. A history of active or latent tuberculosis (TB); TB testing should be performed at screening (Quantiferon test). Confirmed active or latent TB the patient can be re-screened after full completion of anti-tuberculosis treatment (9 months of Isoniazide therapy)\n8. History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease.\n9. History of CNS or spinal cord tumor, metabolic or infectious causes of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis or non MS-progressive neurological condition affecting the ability to perform the study assessments\n10. History of cytopenia consistent with MDS diagnosis\n11. History of sickle cell anemia or other hemoglinopathies\n12. Primary immune deficiency disease\n13. Patients with positive antiphospholipid antibodies, anti-cardiolipin or lupus anticoagulant.\n14. History of moderate or worse renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n15. Prevalent inflammatory diseases of the GI tract (e.g. Inflammatory bowel disease, Peptic ulcer) which could result in a higher risk for gastrointestinal perforation.\n16. The following cardiac conditions:\n\n    New York Heart Association Stage III or IV congestive heart failure Myocardial infarction or coronary artery bypass graft ≤ 6 months prior to enrollment History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n17. History of severe non-ischemic cardiomyopathy Medications:\n\n    Systemic corticosteroids \\>10 mg within 7 days prior to leukapheresis; T cell targeting drugs (e.g. mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis, Previous CAR T cell therapy, Live vaccines within 30 days prior to leukapheresis, Current Cytotoxic drugs Other MS disease modifying drugs (as stated in 5.8.1.)\n18. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative lymphodepletion or rescue medication\u002Fsalvage therapies for treatment related toxicities;\n19. Contraindication of trial related procedures as judged by the investigator\n20. Pregnant of breast-feeding females; female patients of child-bearing potential not willing to practice a highly effective form of birth control from leukapheresis and for 12 months after dosing the IMP\n21. Concurrent participation in another interventional trial\n22. Inability to understand the procedures and risks associated with the Trial.\n23. Any additional contraindication of trial related procedures as judged by the investigator",{"count":165,"type":21},26,[167,168],"PHASE1","PHASE2","The goal of this trial is to assess the feasibility, safety and preliminary efficacy of MB-CART2019.1 in patients with active refractory primary and secondary progressive MS.",[171,81],"Multiple Sclerosis","2026-05-06",{"date":174,"type":35},"2026-05-11",{"date":176,"type":35},"2026-04-01",{"date":178,"type":21},"2030-08-16",{"name":180,"class":181},"Miltenyi Biomedicine GmbH","INDUSTRY",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":53,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":4},"100634363","phase-1-functionally-optimized-cd33-car-t-cell-therapy-targeting-recurrentrefractory-acute-myeloid-leukemia-100634363","NCT07538713","Functionally Optimized CD33 CAR-T Cell Therapy Targeting Recurrent\u002FRefractory Acute Myeloid Leukemia","Clinical Study on the Efficacy and Safety of Functionally Optimized CD33 CAR-T Cells (FO33 CAR-T) Therapy Targeting CD33-Positive Recurrent\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Subjects diagnosed with refractory\u002Frecurrent acute myeloid leukemia (excluding M3) who meet any of the following criteria:\n\n  1. Relapse: Recurrence of leukemia cells in peripheral blood or ≥5% blast cells in bone marrow after complete remission (CR) of AML (excluding other causes such as bone marrow regeneration following consolidation chemotherapy), or extramedullary leukemia infiltration.\n  2. Refractory: First-time cases unresponsive to two cycles of standard therapy; relapse within 12 months after consolidation therapy following CR; relapse after 12 months without response to conventional chemotherapy; two or more relapses; persistent extramedullary leukemia.\n* During enrollment screening, bone marrow flow cytometry must demonstrate a CD33+ expression rate of ≥80% in leukemia cells and\u002For pathological immunohistochemical confirmation of CD33+ extramedullary lesions.\n* Estimated survival duration exceeding 3 months as of the date of informed consent signing.\n* Participants with Eastern Cooperative Oncology Group (ECOG) physical status scores ranging from 0 to 2.\n* Age range of 14 years ≤ ≤ 75 years, inclusive, with no gender restriction.\n* Hemoglobin (HGB) level ≥70 g\u002FL with transfusion capability.\n* Liver\u002Fkidney function and cardiopulmonary function meeting the following criteria:\n\n  1. Creatinine ≤1.5×ULN;\n  2. Left ventricular ejection fraction ≥50%;\n  3. Blood oxygen saturation\\>90%;\n  4. Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.\n* Acceptance of autologous CART cells with peripheral blood tumor burden ≤ 30%;\n* The subject or guardian understands and signs the informed consent form.\n\nExclusion Criteria:\n\n* Presence of one of the following cardiac criteria:\n\n  1. Atrial fibrillation;\n  2. Myocardial infarction (MI) within the past 12 months;\n  3. Prolonged QT syndrome or secondary QT prolongation as determined by the investigator;\n  4. Echocardiographic left ventricular systolic fraction (LVSF) \\\u003C30% or left ventricular ejection fraction (LVEF) \\\u003C50%;\n  5. Clinically significant pericardial effusion; New York Heart Association (NYHA) class III or IV heart failure (confirmed by echocardiography within 12 months after treatment).\n* Active graft-versus-host disease (GVHD).\n* History of severe pulmonary dysfunction.\n* Concurrent other progressive malignancies.\n* Concurrent severe or persistent infections that cannot be effectively controlled.\n* Concurrent severe autoimmune diseases or congenital immunodeficiency.\n* Active hepatitis (HBV-DNA ≥ 500 IU\u002Fml with abnormal liver function or HCV antibody \\[HCV-Ab\\] positivity, HCV-RNA exceeding the detection limit of analytical methods with abnormal liver function).\n* Human immunodeficiency virus (HIV) infection or syphilis infection.\n* History of severe allergic reactions to biological products (including antibiotics).\n* Presence of central nervous system disorders such as uncontrolled epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, or cerebellar diseases.\n* Female patients in pregnancy or lactation, or planning pregnancy within 12 months.\n* Situations where investigators consider may increase subject risk or interfere with trial outcomes.","14 Years","75 Years",{"count":144,"type":21},[167],"Relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML) currently lacks effective CAR-T therapeutic agents due to the absence of tumor-specific target antigens. Most AML-associated antigens are expressed on normal hematopoietic stem\u002Fprogenitor cells (HSPCs) and healthy tissues, increasing the risk of on-target off-tumor toxicity and non-neoplastic toxicity. CD33 is present on leukemic cells in over 80% of AML patients. Compared with CLL-1, CD123 and other targets, CD33 exhibits higher expression across diverse AML subtypes, reducing the risk of treatment failure and relapse caused by antigen escape and thus serving as an ideal therapeutic target for AML. However, conventional CD33-targeted CAR-T cells demonstrate suboptimal efficacy in clinical trials, accompanied by significant toxicity and inadequate in vivo expansion. To further investigate the safety and efficacy of CAR-T therapy for AML, our center has initiated a clinical trial of functionally optimized CD33 CAR-T (FO33 CAR-T) cells for R\u002FR AML. We constructed a lentiviral CAR vector containing the CD33-targeting scFv, 4-1BB, and CD3ζ, followed by insertion of adjuvant molecule X. FO33 CAR-T cells showed superior cytotoxicity against AML cell lines and enhanced biological activity compared with conventional CD33 CAR-T cells, and exerted safe and effective antitumor effects in preclinical models. This single-center, open-label, prospective clinical trial aims to evaluate the safety and efficacy of FO33 CAR-T cells in patients with R\u002FR AML, as well as to characterize the pharmacokinetic and pharmacodynamic (PK\u002FPD) profiles of this therapy.",[81,195],"CD33 Positive Acute Myelogenous Leukemia","NOT_YET_RECRUITING","2026-04-19",{"date":199,"type":35},"2026-04-23",{"date":150,"type":21},{"date":202,"type":21},"2028-05-31",{"name":204,"class":42},"Qi deng",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":53,"phases":216,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100577754","nutrition-outreach-in-systems-of-healthcare-100577754","NCT06802406","Nutrition OUtReach In Systems of Healthcare","NOURISH","Inclusion Criteria:\n\n* Planning to receive transplant or cell therapy\n* Screen positive for food insecurity by answering \"often true\" or \"sometimes true\" to one of the following:\n\n  * \"Within the past 12 months, you worried that your food would run out before you got money to buy more,\"\n  * \"Within the past 12 months, the food you bought just didn't last and you didn't have money to get more.\"\n* Age 8 - 80\n* Able to read\u002Fwrite English or Spanish (many patient-reported outcome measures lack validated translations in other languages)\n\nExclusion Criteria:\n\n* Patients who do not tolerate oral nutrition at the time of study enrollment","8 Years","80 Years",{"count":215,"type":21},210,[55],"Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult.\n\nBy doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.",[219,220,59,221],"ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Autologous Haemopoietic Stem Cell Transplant","Food Insecurity",[223],"nutrition, food insecurity","2026-04-14",{"date":226,"type":35},"2026-04-20",{"date":228,"type":35},"2025-05-01",{"date":230,"type":21},"2029-05",{"name":232,"class":42},"University of Kansas Medical Center",4,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":53,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":43},"100567215","thrive-car-t-digital-app-100567215","NCT06665295","THRIVE-CAR-T Digital App","Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy","THRIVE-CAR-T","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Ability to understand English\n3. Diagnosis of a hematologic malignancy\n4. Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product\n\nExclusion Criteria:\n\n1. Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment\n2. Already participating in another supportive care clinical trial",{"count":243,"type":21},100,[55],"The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question\\[s\\] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.",[25],[248,249,250,251],"car-t cell therapy","digital application","mobile application","randomized controlled trial","2026-03-26",{"date":176,"type":35},{"date":255,"type":35},"2024-10-17",{"date":257,"type":21},"2026-12-31",{"name":259,"class":42},"Patrick C. Johnson, MD",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":189,"maxAge":190,"enrollmentInfo":267,"targetDuration":4,"studyType":53,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":277,"locationsCount":4},"100622408","phase-1-cd19baff-r-in-vivo-car-t-cell-therapy-targeting-relapsedrefractory-b-cell-acute-leukemiamalignant-lymphoma-100622408","NCT07383233","CD19\u002FBAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed\u002FRefractory B Cell Acute Leukemia\u002FMalignant Lymphoma","Clinical Study on the Efficacy and Safety of CD19\u002FBAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed\u002FRefractory B Cell Acute Leukemia\u002FMalignant Lymphoma","Inclusion Criteria:\n\nSubjects must meet all of the following criteria：\n\n* The diagnosis was confirmed as B-cell acute leukemia\u002Fmalignant lymphoma. Requirements for prior treatment: Patients with B-cell acute leukemia\u002Fmalignant lymphoma who failed to achieve PR after first-line therapy or experienced relapse within 12 months after first-line therapy; or those with relapsed\u002Frefractory disease after second-line therapy (a standardized chemotherapy regimen plus salvage chemotherapy). During screening, the patient was in a state of disease recurrence or refractory condition: Acute B-cell leukemia: a) Relapse definition: The presence of blast cells (proportion\\>5%) in peripheral blood or bone marrow after achieving complete remission with a standardized treatment regimen (including hematopoietic stem cell transplantation), or the development of extramedullary disease; b) Refractory definition: Failure to achieve complete remission after at least two courses of standardized induction therapy. B-cell lymphoma: a) Definition of relapse: PD after achieving remission (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractory: i. No response to the last treatment: PD during\u002Fafter the last treatment or SD with a duration of less than 6 months; ii. Relapse or progression after ASCT, including: relapse or PD within 12 months after ASCT, and no response to the last treatment (SD or PD) if salvage therapy is administered.\n* The subject's predicted survival time is not less than three months.\n* Tumor cells confirmed to be CD19\u002FBAFFR positive by Flow Cytometry (FCM) or Immunohistochemistry.\n* Patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed\u002Frefractory B-cell lymphoma (B-LY) who have at least one evaluable lesion.\n* Age 14-75 years (inclusive), both genders eligible.\n* ECOG performance status ≤ 3.\n* HGB≥70g\u002FL(transfusion permitted).\n* The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance \\> 50 ml\u002Fmin (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is permitted. ②LVEF≥50%,② Oxygen saturation ≥90%,③ SCr≤2.5ULN,④ALT and AST≤3ULN,TBil≤2ULN. In the investigator's judgment, if organ dysfunction is associated with the current disease, the enrollment decision will be made by the investigator.\n* Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.\n* The subject or guardian understands and signs the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\nAny of the following conditions will not be eligible for enrolment:\n\n* Severe heart failure with left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* History of severe pulmonary function impairment.\n* Concurrent other progressive malignant tumors.\n* Concurrent severe infection that cannot be effectively controlled.\n* Concurrent severe autoimmune disease or congenital immunodeficiency.\n* Active hepatitis (hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) positive with HBV DNA copy number greater than the upper limit of normal at the study center; Anti-HCV positive with HCV-RNA copy number greater than the upper limit of normal at the study center).\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.\n* History of severe allergy to biological products (including antibiotics).\n* Received inactivated vaccines such as influenza vaccine, COVID-19 vaccine within 4 weeks prior to screening, or received live attenuated vaccines (such as measles, varicella vaccines) within 8 weeks.\n* Patients with other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, and patients considered unsuitable for this study by the investigator.",{"count":144,"type":21},[167],"The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. In vivo CAR-T cell therapy eliminates the need for ex vivo preparation, significantly reducing treatment costs and procedural complexity. It enables immediate use, thereby improving patient accessibility. CD19 is stably overexpressed in more than 90% of B-cell malignancies. BAFF plays a core regulatory role in the survival, maturation, and homeostasis maintenance of B cells. BAFF-R is selectively expressed on the surface of mature B cell subsets and most B-cell malignancies. Currently, BAFF-R-based CAR-T therapy is in preclinical and early clinical research stages, demonstrating promising therapeutic potential, particularly offering a novel treatment option for patients with CD19-negative or drug-resistant B-cell tumors. The use of CD19\u002FBAFF-R in vivo CAR-T cells as a new anti-tumor therapy may provide a new research direction for the treatment of relapsed\u002Frefractory B-cell acute leukemia\u002Fmalignant lymphoma.",[110,81,271],"Acute Leukemia","2026-01-28",{"date":274,"type":35},"2026-02-03",{"date":150,"type":21},{"date":202,"type":21},{"name":204,"class":42},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":4},"100621823","neurological-and-cognitive-dysfunction-following-car-t-treatment-icans-and-beyond-100621823","NCT07375628","Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond","Inclusion Criteria:\n\n* Age \\> 20\n\n  * Planned to undergo CAR-T treatment\n  * No known prior CNS diseases or head trauma\n  * Prior CNS involvement of lymphoma or acute lymphoblastic leukemia is allowed, provided it is well-controlled and treated at inclusion\n  * Capable of receiving tailored information about the research project and signing informed consent\n\nExclusion Criteria:\n\n* • Age under 20 years\n\n  * The patient has previously indicated they wish to refrain from research participation\n  * Another concurrent neuroinflammatory or neurodegenerative disease, or malignant disease (other than the underlying condition) in the central nervous system","20 Years",{"count":286,"type":21},10,"This is a phase 4 non-interventional single center trial. We aim to prospectively include patients scheduled to undergo CAR-T therapy at ME CAST, Karolinska University Hospital Huddinge, to study ICANS. Because ICANS develops rapidly, inclusion during this potentially life-threatening phase would not be feasible; patients must therefore be enrolled before they start treatment. We aim to include patients who are clinically at high risk of developing ICANS. The risk of ICANS is assessed based on diagnosis, tumor burden, CAR-T product, and inflammatory status prior to treatment initiation. We plan to compare patients who develop ICANS grade 2-4 with patients who develop no ICANS or at most grade 1. Patients will undergo Positron Emission Tomography (PET) with two different tracers: (1) PBR28 for TSPO, which provides a measure of brain inflammation-this ligand binds to microglial cells-and (2) 11C-UCB-J for SV2A, which provides a measure of synaptic density in the brain. The results will be compared with magnetic resonance imaging. We will collect blood, bone marrow and cerebrospinal fluid (CSF) samples from this patient cohort. Samples will be taken from all patients before, during, and after CAR-T treatment. Participation in the study also includes computer-based cognitive testing, neuropsychological evaluation and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.",[81,29,289],"Cognitive and Executive Dysfunction",[291,292,293,294,295],"Icans","CAR T cell therapy","Fatigue","Cognitive dysfunction","PET scan","2026-01-22",{"date":298,"type":35},"2026-01-29",{"date":300,"type":21},"2026-02",{"date":230,"type":21},{"name":303,"class":42},"Karolinska University Hospital",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":53,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100615151","phase-2-daly-ii-japanmb-cart20191-for-dlbcl-100615151","NCT07288879","DALY II Japan\u002FMB-CART2019.1 for DLBCL","A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and\u002For Refractory Diffuse Large B Cell Lymphoma.","DALY II Japan","Inclusion Criteria:\n\n1. Histologically confirmed DLBCL or associated subtype, defined by WHO 2016 classification:\n\n   * DLBCL not otherwise specified (NOS)\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n   * High-grade B-cell lymphoma, NOS\n   * Primary mediastinal (thymic) large B-cell lymphoma\n   * Transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma, follicular lymphoma Grade 3B)\n2. Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed autologous stem cell transplant (ASCT), or being ineligible for or not consenting to ASCT 2.1 Chemotherapy-refractory disease is defined as one of the following:\n\n   * No response to last line of therapy:\n\n     * Progressive disease (PD) as best response to most recent therapy regimen\n     * Stable disease (SD) as best response to most recent therapy with duration no longer than 6 months from last dose of therapy OR\n   * Relapsed or persistent disease after prior ASCT for lymphoma\n\n     * Disease progression or relapse less than or equal to 24 months of ASCT\n     * If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy 2.2 Disease relapse in subjects without prior ASCT is defined as relapse of disease in ≤ 12 months after the last dose of most recent therapy regimen 2.3 Ineligible for ASCT is defined as meeting one of the following criteria:\n   * Chemotherapy-refractory disease after salvage therapy\n   * Disease progression or relapse ≤ 12 months after salvage therapy\n   * Intolerance to salvage therapy\n\n   In addition, all subjects must have:\n3. Age ≥18 years\n4. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to DLBCL\n5. Measurable disease according to Lugano 2014 criteria for assessing fluorodeoxyglucose-positron emission tomography (FDG-PET)\u002Fcomputer tomography (CT) in lymphoma (Cheson et al, 2014)\n6. CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy; however, 6.1 Subject must have at least 20 unstained slides of tissue available prior to MB-CART2019.1 infusion 6.2 If archival tissue is not available, subject must be willing to undergo attempted repeat biopsy\n7. No clinical suspicion of central nervous system (CNS) lymphoma\n8. If the subject has history of CNS disease, then he\u002Fshe must 8.1. Have no signs or symptoms of CNS disease 8.2. Have no active disease on magnetic resonance imaging (MRI) 8.3. Have no large cell lymphoma present in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells (WBCs)\n9. If the subject has history of cerebral vascular accident (CVA) 9.1. The CVA event must be greater than 12 months prior to leukapheresis 9.2. Any neurological deficits must be stable\n10. An estimated creatinine clearance by Cockcroft-Gault Equation (eGFR) \\> 60mL\u002Fmin\n11. Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO)\n12. Resting O2 saturation \\>90% on room air\n13. Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) \\\u003C5 times the Upper Limit of Normal (ULN) for age\n14. Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n15. Absolute neutrophil count (ANC) \\> 1000\u002FμL\n16. Absolute lymphocyte count \\> 100\u002FμL\n17. Platelet count \\> 50,000\u002FμL\n18. Estimated life expectancy of more than 3 months other than primary disease\n19. Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study\n\nExclusion Criteria:\n\n1. Primary CNS lymphoma\n2. Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL)\n3. Unable to give informed consent\n4. Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), unless confirmed to be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required as recommended in the Japanese guidelines for Hepatitis B treatment if HBsAg negative and anti-HBc positive\n5. Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing\n6. Known history of active seizure or presence of seizure activities or on active anti-seizure medications within the prior 12 months\n7. Known history of CVA within prior 12 months\n8. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease\n9. Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity\n10. Active systemic fungal, viral or bacterial infection\n11. Pregnant or breast-feeding woman\n12. Previous or concurrent malignancy with the following exceptions:\n\n    * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n    * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n    * Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n    * A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n13. History of non-neurologic autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive or systemic disease modifying agents within the last 2 years\n14. Medical condition requiring prolonged use of systemic corticosteroids equivalent to Prednisone \\>10 mg\u002Fday\n15. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n16. Concurrent radiotherapy (allow up to time of leukapheresis)\n17. Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline. (Appendix 6, Section 13.6)\n18. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n19. Refusal to participate in additional lentiviral gene therapy LTFU protocol\n20. Prior CAR T cell therapy for any indication\n21. Prior allogeneic stem cell transplant for any indication.\n22. Prior bispecific antibodies for cancer therapy\n23. Prior T cell receptor-engineered T cell therapy\n24. Prior anti CD 19 immunotherapy\n25. Hypersensitivity against any drug including MB-CART2019.1 (and the constituents used in the production, ingredients\u002Fimpurities, including bovine and rodent-derived components), that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication\u002Fsalvage therapies for treatment related toxicities.",{"count":313,"type":21},31,[168],"DALY II Japan is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy.",[317,81],"DLBCL - Diffuse Large B Cell Lymphoma",[319,320],"CAR T Cell therapy","DLBCL","2026-01-06",{"date":323,"type":35},"2026-01-08",{"date":325,"type":35},"2025-12-11",{"date":327,"type":21},"2028-12-31",{"name":180,"class":181},5,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":53,"phases":339,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":43},"100615708","phase-4-rsv-vaccine-response-in-stem-cell-and-car-t-therapy-recipients-100615708","NCT07296120","RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients","Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of hematological malignancy\n* Treatment with HSCT or CAR-T therapy\n* Must be able to give informed consent\n* Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination\n* Must be willing to provide blood samples at four weeks and six months post-vaccination\n* Must have an insurance plan that covers the cost of recieving the RSV vaccine.\n\nExclusion Criteria:\n\n* History of a severe allergic reaction to any component of the RSV vaccine\n* Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months",{"count":338,"type":21},30,[340],"PHASE4","This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.\n\nThe main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.",[59,343,344],"RSV Immunization","Bone Marrow Transplant - Autologous or Allogeneic","2025-12-18",{"date":347,"type":35},"2025-12-22",{"date":349,"type":21},"2026-01-01",{"date":351,"type":21},"2027-06-30",{"name":353,"class":42},"The Cooper Health System",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":364,"conditions":365,"keywords":369,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100615167","patient-reported-outcomes-in-allogeneic-stem-cell-transplantation-and-car-t-therapy-100615167","NCT07289087","Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy","A Real-World Observational Study on Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation (Allo-SCT) and CAR-T Therapy","QOL-ONE PRO-CT","Inclusion Criteria:\n\n* Diagnosed with a hematologic malignancy (e.g., leukemia, lymphoma, multiple myeloma)\n* Undergoing either allogeneic SCT or CAR-T therapy\n* Able and willing to provide written informed consent\n* Sufficient Italian proficiency to complete the HM-PRO\n* Signed informed consent\n\nExclusion Criteria:\n\n* Cognitive or physical impairments that preclude the ability to complete questionnaires\n* Estimated life expectancy \\\u003C 7 days at the time of admission",{"count":363,"type":21},162,"3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Patients will be enrolled at hospital admission for the index inpatient procedure and followed through the inpatient stay (admission → discharge). The study is non-randomized and designed to describe trajectories of symptoms and HRQoL and to estimate the between-group difference in deterioration of HM-PRO scores (primary estimand: mean difference in change score, CAR-T vs allo-SCT).",[366,367,368,81],"Quality of Life","Patient Reported Outcome (PRO)","Allogeneic Blood and Marrow Transplantation (BMT)",[366,370,371,372,107,373,110],"CAR-T cell therapy","Allogenic BMT","Patient Reported Outcome","Multiple Myeloma","2025-12-04",{"date":376,"type":35},"2025-12-17",{"date":378,"type":21},"2026-02-15",{"date":380,"type":21},"2027-04-01",{"name":382,"class":42},"Associazione Qol-one",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":190,"enrollmentInfo":390,"targetDuration":4,"studyType":53,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":43},"100611878","early-phase-1-tc-d101-cell-therapy-for-patients-with-dll3-positive-sclc-100611878","NCT07246304","TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC","A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed\u002FRefractory Primary Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-75 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. DLL3-positive r\u002Fr SCLC confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B\u002FC, syphilis).\n8. Pregnant or breastfeeding women.\n9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.\n\n11\\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.",{"count":391,"type":21},24,[104],"This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed\u002FRefractory primary small cell lung cancer(r\u002Fr SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.",[395,59],"Small Cell Lung Cancer ( SCLC )",[395,59,397],"DLL3","2025-11-17",{"date":400,"type":35},"2025-11-24",{"date":402,"type":21},"2025-11-30",{"date":404,"type":21},"2028-11-30",{"name":406,"class":181},"TCRCure Biopharma Ltd.",{"id":408,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":410,"keywords":411,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":417,"locationsCount":43},"100598748",{"count":20,"type":21},[25],[27,28,29,30],"2025-10-09",{"date":414,"type":35},"2025-10-14",{"date":37,"type":35},{"date":39,"type":21},{"name":41,"class":42},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":190,"enrollmentInfo":425,"targetDuration":4,"studyType":53,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":43},"100608231","phase-1-a-study-of-a-car028-treatment-in-subjects-with-relapsed-or-refractory-acute-myeloid-leukemia-100608231","NCT07198867","A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia","A Study of A-CAR028 Treatment in Subjects With Relapsed\u002F Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 18 to 75 years old at the time of signing the Informed Consent Form (ICF)\n* More than 12 weeks of expected survival\n* ECOG score 0 or 1\n* Relapsed or refractory AML\n* Adequate organ function\n\nExclusion Criteria:\n\n* Acute Promyelocytic Leukemia (APL)\n* Mixed Phenotype Acute Leukemia (MPAL)\n* Acute Undifferentiated Leukemia (AUL)\n* Only extramedullary leukemia\n* Known allergies to the components or excipients of the A-CAR028 cell product\n* Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure\n* Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF\n* Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)\n* A stroke or seizure occurred within 12 months prior to signing the ICF\n* Malignancy history within 5 years prior to signing the ICF\n* Uncontrolled active infection\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive\n* Live vaccine injection within 4 weeks prior to signing the ICF\n* Acute or chronic graft-versus-host disease (GVHD) was present at screening\n* Inadequate washing time for previous treatment\n* Previously treated with CAR-T cell products or genetically modified T cell therapies",{"count":426,"type":21},20,[167],"This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed\u002Frefractory acute myeloid leukemia patients",[430,59],"Acute Myeloid Leukemia (AML)",[432,433],"A-CAR028","Acute Myeloid Leukemia","2025-09-22",{"date":436,"type":35},"2025-09-30",{"date":436,"type":21},{"date":439,"type":21},"2027-12-31",{"name":441,"class":42},"First Affiliated Hospital of Zhejiang University",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":449,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":53,"phases":451,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":43},"100558651","phase-1-study-of-therapeutic-efficacy-of-car-t-cell-therapy-in-patients-with-mdr-srns-100558651","NCT06553898","Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS","Study of Therapeutic Efficacy of Anti-B Cell Maturation Antigen（BCMA）\u002FCluster of Differentiation 70(CD70 )CAR-T Cells in Patients With Multi-drug Resistant SRNS","Inclusion Criteria:\n\n* 1\\. Age ≥2 years old, gender unlimited;\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes （KDIGO） Guidelines and have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission (at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus; Other hormone replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab); Or if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin inhibitor, if the researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks and the patient or guardian has fully informed consent;\n* 3\\. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* 4\\. The functions of important organs are basically normal: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2# Liver function: Asparagus cochinchinensis transaseminase (AST) and Alanine Aminotransferase (ALT)≤3.0 upper limit of normal, Total Bilirubin (TBIL) in serum ≤2.0×upper limit of normal; Lung function: No serious lung lesions, SpO2≥92%;\n* 5\\. Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;\n* 6\\. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;\n* 7\\. Participants or their guardians agrees to participate in the clinical trial and sign the informed consent form which indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* 1\\. Received CAR T cell therapy or other gene-modified cell therapy previously;\n* 2\\. Patients had a cerebrovascular accident or seizure, or other active central nervous system disease within 6 months;\n* 3\\. Genetic tests have confirmed hereditary kidney disease;\n* 4\\. Renal biopsy has been confirmed as immunoglobulin A nephropathy, idiopathic membranous nephropathy or membranoproliferative glomerulonephritis;\n* 5\\. Renal replacement therapy has been or is being performed within 3 months prior to transfusion. (if acute kidney injury factors were considered, patients with chronic kidney disease were excluded, and the benefits outweighed the risks as determined by the investigator and with the full and informed consent of the patient or guardian could be considered for inclusion);\n* 6\\. Renal replacement therapy has been or is being performed within 3 months prior to transfusion;\n* 7\\. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs;\n* 8\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening;\n* 9\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;\n* 10\\. Macrophage activation syndrome occurred within 1 month prior to screening;\n* 11\\. Received live vaccine within 4 weeks before screening;\n* 12\\. Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;\n* 13\\. Tested positive in Blood pregnancy test;\n* 14\\. Patients who participated in other clinical study within 1 months prior to enrollment;\n* 15\\. Any other conditions that the investigators deem it unsuitable for the study.","2 Years",{"count":144,"type":21},[167],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA\u002FCD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS",[454,59],"Multi-Drug Resistant Nephrotic Syndrome",[456,370,454],"MDR-SRNS","2025-08-28",{"date":459,"type":35},"2025-08-29",{"date":461,"type":35},"2024-08-13",{"date":463,"type":21},"2027-07-31",{"name":465,"class":42},"The Children's Hospital of Zhejiang University School of Medicine",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":53,"phases":475,"briefSummary":476,"conditions":477,"keywords":480,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":43},"100602217","anti-cd19-car-t-combined-with-btki-to-treat-newly-diagnosed-high-risk-cllsll-100602217","NCT07120633","Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL\u002FSLL","The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients","Inclusion Criteria:\n\n1. The patient voluntarily participates and signs the informed consent form;\n2. Age ≥18 years old;\n3. Confirmed as CLL\u002FSLL according to WHO standards, and confirmed positive expression of CD19 through flow cytometry or immunohistochemical detection;\n4. Subjects:\n\n   4.1 First-time patients who have not received systemic radiotherapy or chemotherapy in the past. (Except for the following situations: Short-term systemic corticosteroids for disease control, improvement of performance status or treatment of non-cancer indications (use for ≤14 days, prednisone \\\u003C100 mg\u002Fd or dexamethasone ≤20 mg\u002Fd). Steroids must be discontinued before the study of treatment. Inhaled steroids, topical steroids and alternative corticosteroids are permitted for the treatment of asthma.\n\n   4.2 Meet the treatment indications of iwCLL 2018, including: Progressive bone marrow failure caused by bone marrow infiltration due to CLL (hemoglobin \\\u003C10 g\u002FL and platelet count \\\u003C100×10⁹\u002FL); 4.3 Patients with high-risk genetic molecular factors (del(17p), TP53 gene deletion\u002Fmutation (vaf\\>10%), U-IGHV, complex karyotype); 4.4 Have measurable or evaluable lesions (positive peripheral blood flow results or lesions ≥1cm evaluated based on PET-CT\u002FCT\u002FMRI).\n\n   4.5 No contraindications for treatment with Bruton's tyrosine kinase (BTK) inhibitors or BCL2 inhibitors.\n5. Good functions of major tissues and organs:\n\n   5.1 Liver function: ALT\u002FAST\\\u003C3 times the upper limit of the normal value and total bilirubin ≤34.2 μmol\u002FL; 5.2 Renal function: Creatinine \\\u003C 220 μmol\u002FL; 5.3 Pulmonary function: Indoor oxygen saturation ≥95%; 5.4 Cardiac function: Left ventricular ejection fraction ≥40%.\n6. The peripheral superficial veins have smooth blood circulation and can accept intravenous infusion.\n7. ECOG score ≤2;\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. CLL patients who have undergone Richter transformation;\n2. Patients known to have active malignant tumors involving the central nervous system. For patients who have previously suffered from central nervous system diseases and have received effective treatment, if they have completed treatment for at least 3 months before enrollment, have no evidence of symptomatic diseases, and the imaging examination shows abnormal stability, they will be considered for enrollment.\n3. There is a history of primary malignant tumor, and it has not been relieved for at least two years. The following situations are not subject to the two-year limit: non-melanoma skin cancer, completely resected stage 1 solid tumors with low recurrence risk, radical treatment of local prostate cancer, biopsion-revealed cervical cancer in situ or smear-revealed squamous intraepithelial lesions, and completely resected breast cancer in situ.\n4. Active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection;\n5. There was an uncontrollable systemic fungal, bacterial or viral infection within 4 weeks before enrollment;\n6. Have a history of any of the following cardiovascular diseases within the past 6 months: grade III or IV heart failure as defined by the New York Heart Association, angioplasty or stent implantation, myocardial infarction, unstable angina pectoris, clinically obvious arrhythmia, or other clinically significant heart diseases;\n7. Women who are pregnant (with a positive urine\u002Fblood pregnancy test) or breastfeeding;\n8. Patients who are allergic to large molecule biological drugs such as antibodies or cytokines;\n9. Had systemic hormones or immunosuppressive drugs been used within 4 weeks before enrollment (except for patients with inhaled hormones);\n10. Suffer from mental illness;\n11. The researcher determined that the patient had other conditions that made him unsuitable for inclusion in the group.",{"count":474,"type":21},50,[55],"At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.",[478,59,479],"CLL","SLL",[481,478,479],"CAR-T","2025-08-12",{"date":484,"type":35},"2025-08-13",{"date":486,"type":21},"2025-09-01",{"date":488,"type":21},"2028-09-01",{"name":490,"class":42},"The Affiliated Hospital of Xuzhou Medical University",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":512,"locationsCount":43},"100586945","brain-function-and-psychological-changes-related-to-cell-therapy-for-autoimmune-hemolytic-anemia-100586945","NCT06921980","Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia","Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy","Inclusion Criteria:\n\n* Diagnosis of AIHA\n* Subjects will receive cell therapy such as CAR T-cell therapy\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":426,"type":21},"Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior.\n\nBrain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.",[502,503,504,505],"CAR T-cell Therapy","Autoimmune Hemolytic Anemia","Brain Function","Psychological Well-Being","2025-07-31",{"date":508,"type":35},"2025-08-05",{"date":510,"type":35},"2025-02-25",{"date":257,"type":21},{"name":513,"class":42},"Institute of Hematology & Blood Diseases Hospital, China",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":190,"enrollmentInfo":521,"targetDuration":4,"studyType":53,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":43},"100563940","phase-1-cd7-car-t-cells-rd13-02-in-the-treatment-of-relapsedrefractory-severe-aplastic-anemia-100563940","NCT06622694","CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed\u002FRefractory Severe Aplastic Anemia","A Clinical Study of Safety, Efficacy, and Pharmacokinetics of Universal CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed\u002FRefractory Severe Aplastic Anemia","Inclusion Criteria:\n\n* Willing and able to provide written informed consent.\n* Age ≥18 years and ≤75 years.\n* Diagnosed with severe aplastic anemia: Diagnostic criteria refer to the UK Hematology Guidelines (Br J Haematol, 2024, 204(3): 784-804): 1) Bone marrow cellularity \\\u003C25% (or 25-50% but \\\u003C30% residual hematopoietic cell area); 2) At least two of the following conditions must be met: ANC \\\u003C0.5×10\\^9\u002FL, PLT \\\u003C20×10\\^9\u002FL, absolute reticulocyte count \\\u003C60×10\\^9\u002FL; 3) Exclusion of other congenital or acquired hematopoietic failure disorders.\n* Had at least one course of standard-dose therapy with anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) combined with TPO-RA that was ineffective or relapsed after remission within the past 6 months.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Willing and able to comply with the study procedures.\n\nExclusion Criteria:\n\n* Blood cell reduction and hypoplastic bone marrow diseases due to other causes (e.g., hemolytic PNH, hypoplastic MDS\u002FAML, antibody-mediated pancytopenia).\n* Received ATG\u002FALG treatment less than 6 months ago; received TPO-RA treatment less than 4 months ago. Note: Patients on stable doses of cyclosporine or hematopoietic agents at screening can be enrolled if laboratory values are stable.\n* Significant neurological disease history, including dementia, stroke without paralysis, aphasia, seizures, or any neurological history that may pose safety risks regarding cell therapy as judged by the investigator.\n* History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart), or plans for such transplantation in the future.\n* History of autologous or allogeneic CAR T therapy.\n* Any primary immunodeficiency disease.\n* Significant cardiovascular dysfunction history or current significant cardiovascular dysfunction, particularly:\n* Signs or symptoms of congestive heart failure classified as NYHA class ≥III within 12 months prior to enrollment.\n\n  1. Echocardiogram showing left ventricular ejection fraction (LVEF) \\\u003C45% (assessed during screening).\n  2. History of any serious arrhythmia, currently on treatment for arrhythmias, significant history of myocardial infarction, clinically significant valvular heart disease (including mild or greater aortic regurgitation or moderate or greater mitral regurgitation), recurrent syncope, or significant hypercoagulable vascular events (e.g., transient ischemic attack or stroke); history of pulmonary embolism.\n* Liver or lung dysfunction, defined as:\n\n  1. Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≥2.5× the upper limit of normal (ULN);\n  2. Total bilirubin ≥1.5×ULN, except in subjects with Gilbert's syndrome.\n  3. Pulmonary hypertension, including secondary pulmonary hypertension, classified as WHO functional class \\>2.\n* Males with QTcF \\>450 msec; females with QTcF \\>470 msec, based on a single ECG or the average of three repeat ECGs taken more than 3 minutes apart.\n* History of malignancy, excluding adequately treated or surgically removed non-melanoma skin cancer or in situ cancers (e.g., cervical cancer, bladder cancer, breast cancer) without residual disease.\n* Pregnant or breastfeeding females, or females planning to become pregnant during the study or within 12 months after RD13-02 infusion.\n* History or signs of significant chronic active or recurrent infections, or significant chronic active or recurrent infections requiring antibiotics, antivirals, or antifungal treatments based on screening laboratory results.\n* Uncontrolled infections at screening. Patients with uncomplicated urinary tract infections (UTIs) and uncomplicated bacterial pharyngitis responding to active treatment may be included with investigator and medical monitor approval.\n* Positive screening for HBsAg, HCV RNA, or HIV. If a subject is HBsAg negative but HBcAb positive, hepatitis B virus DNA testing should be performed; subjects with positive hepatitis B virus DNA should be excluded from the study.\n* Vaccination with live attenuated vaccines within 4 weeks prior to enrollment, or plans to receive live attenuated vaccines during the study.\n* PT, APTT, or INR \\>1.2×ULN, except for subjects on stable doses of anticoagulants who can discontinue treatment prior to using intravenous access procedures.\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² calculated using the CKD-EPI formula; if eGFR ≥30 mL\u002Fmin\u002F1.73 m² but \\\u003C45 mL\u002Fmin\u002F1.73 m², adjust fludarabine dosing in the lymphodepleting regimen based on renal function.\n* History of drug or alcohol abuse within the past year.\n* Currently enrolled in other experimental device or drug studies, or less than 30 days since ending other experimental device or drug interventions, or less than 5 half-lives (whichever is longer).\n* History of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or treatment (including lymphodepleting regimen). For detailed information about study drug components, refer to the investigator brochure (IB).\n* Any condition the investigator believes may affect participation, pose safety risks to the subjects, or potentially confound the interpretation of study results.",{"count":522,"type":21},15,[167],"This trial is exploratory research aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD13-02, a universal CD7 CAR T therapy, in subjects with relapsed\u002Frefractory severe aplastic anemia (SAA)",[526,527,528,502],"Severe Aplastic Anemia","Relapse","Refractory","2025-07-23",{"date":531,"type":35},"2025-07-24",{"date":533,"type":35},"2025-06-19",{"date":257,"type":21},{"name":513,"class":42},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":544,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":53,"phases":547,"briefSummary":548,"conditions":549,"keywords":554,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":43},"100570128","phase-1-pre-emptive-anakinra-for-cytokine-event-reduction-100570128","NCT06703216","Pre-emptive Anakinra for Cytokine Event Reduction","Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells","PACER","• Patient consent and parental assent will be obtained.\n\nNOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.\n\n* Patients or their parents\u002Flegally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.\n* The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Patients who are between the age of 1 to 26 years\n* Relapsed or refractory B-acute lymphoblastic leukemia\n\n  * 2nd or greater marrow relapse OR\n  * Central nervous system (CNS) relapse OR\n  * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR\n  * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR\n  * Ineligible for allogeneic HSCT because of:\n\n    * Comorbid disease\n    * Other contraindications to allogeneic HSCT conditioning\n    * No suitable donor\n    * Prior HSCT\n    * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician\n  * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.\n* Adequate organ function defined as:\n\n  * Alanine aminotransferase (ALT) \\\u003C 500 U\u002FL\n  * Bilirubin ≤2.0 mg\u002FdL\n  * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \\>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.\n  * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.\n  * Serum creatinine below the values in the below table, based on age\u002Fsex assigned at birth: Maximum Serum Creatinine (mg\u002FdL) Age (years) Male Female 1 to \\\u003C2 0.6 0.6 2 to \\\u003C6 0.8 0.8 6 to \\\u003C10 1.0 1.0 10 to \\\u003C13 1.2 1.2 13 to \\\u003C16 1.5 1.4 ≥16 1.7 1.4\n* Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy\n* Receiving commercially available tisagenlecleucel","1 Year","25 Years",{"count":391,"type":21},[167,168],"Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults.\n\nPatient Population: Children and young adults \\\u003C25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy.\n\nStudy Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \\>\u002F=5% bone marrow blasts or lymphoblasts in the peripheral blood.\n\nTreatment Plan:\n\nThis is a single arm unblinded study in which patients will receive anakinra, 2.5 mg\u002Fkg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \\>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg\u002Fkg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.",[550,59,551,552,553],"B-Acute Lymphoblastic Leukemia","Cytokine Release Syndrome","Immune Effector Cell Associated Neurotoxicity Syndrome","Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome",[555,551,556,557,558,559,560,552],"Anakinra","CAR-T Therapy","Pediatric","B-acute lymphoblastic leukemia","Prophylaxis","Inflammatory Toxicity","2025-06-12",{"date":563,"type":35},"2025-06-15",{"date":565,"type":21},"2025-08",{"date":567,"type":21},"2030-02-28",{"name":569,"class":42},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":577,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":53,"phases":579,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":43},"100587904","phase-1-study-of-bcmacd70-car-t-therapy-for-refractory-csle-100587904","NCT06934447","Study of BCMA\u002FCD70 CAR-T Therapy for Refractory cSLE","Study of BCMA\u002FCD70 Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Childhood-oneset Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Age:≥5 years old;\n2. Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE classification criteria；Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab); or Intolerant to standard treatments;\n3. SLEDAI 2K score≥8 points;\n4. The functions of important organs are as follows: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2；Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No serious lung lesions, SpO2≥92%;\n5. No prior CAR-T therapy; or recurrence or poor response after previous treatment with autologous or allogeneic CAR-T targeting CD19 (as assessed by the investigator).\n6. Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;\n7. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;\n8. Participants or their guardians agrees to participate in the clinical trial and sign the informed consent form which indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);\n2. Severe acute nephritis: Patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; Or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg\u002Fkg\u002Fday or equivalent amount of other steriod), cyclophosphamide, or MMF treatment;\n3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；\n4. Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;\n5. Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；\n6. History of organ transplantation or hematopoietic stem cell transplantation, or ≥Grade 2 GVHD within 2 weeks prior to screening；\n7. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;\n8. Received live vaccine within 4 weeks before screening;\n9. Tested positive in Blood pregnancy test；\n10. Previous or concurrent malignancy；\n11. Patients who participated in other clinical study within 1 months prior to enrollment; Any other conditions that the investigators deem it unsuitable for the study.","5 Years",{"count":144,"type":21},[167],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA\u002FCD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.",[81,582,583],"Systemic Lupus Erythematosus","BCMA",[585,586,583],"systemic lupus erythematosus","Chimeric antigen receptor (CAR) T-cell","2025-04-22",{"date":589,"type":35},"2025-04-25",{"date":589,"type":21},{"date":592,"type":21},"2028-04-01",{"name":465,"class":42},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":53,"phases":603,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":196,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":43},"100587957","study-to-evaluate-the-efficacy-and-safety-of-axicabtagene-ciloleucel-injection-as-first-line-therapy-of-high-risk-large-b-cell-lymphoma-100587957","NCT06935136","Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma","A Single-Arm, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed LBCL (Large B-Cell Lymphoma) according to the WHO 2016 classification, including the following subtypes:DLBCL-NOS (Diffuse Large B-Cell Lymphoma, Not Otherwise Specified),HGBL (High-Grade B-Cell Lymphoma, including HGBL with MYC, BCL-2, and\u002For BCL-6 rearrangements (DHL\u002FTHL), HGBL-NOS),DLBCL transformed from follicular or marginal zone lymphoma, eligible if the patient has not previously received anthracycline-containing therapy\n* International Prognostic Index (IPI) score of 2-5 at initial diagnosis.\n* Individuals must have a positive interim positron emission tomography (PET) (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy or high-risk ctDNA status (ctDNA levels not reduced by at least 2-log after two cycles of R-chemotherapy)\n* Age of 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Adequate renal, hepatic, pulmonary, and cardiac function, defined as:\n\n  * Creatinine clearance (estimated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin\n  * Serum ALT\u002FAST ≤ 2.5 × Upper Limit of Normal (ULN)\n  * Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome)\n  * Left ventricular ejection fraction ≥ 50%, no pericardial effusion as determined by echocardiography, and no clinically significant arrhythmias No clinically significant pleural effusion\n  * Baseline peripheral oxygen saturation \\> 92% under room air ventilation\n  * At least one measurable lesion.\n  * For women of childbearing potential, a negative serum pregnancy test is required (women who have undergone surgical sterilization or are postmenopausal for at least 2 years are considered not to be of childbearing potential).\n\nExclusion Criteria:\n\n* According to the WHO 2016 classification, patients with the following subtypes are excluded:\n\n  * LBCL with T-cell\u002Fhistiocyte-rich background\n  * Primary central nervous system DLBCL\n  * PMBCL (Primary Mediastinal B-Cell Lymphoma)\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical HL (Hodgkin Lymphoma)\n  * Burkitt lymphoma\n  * History of Richter transformation in chronic lymphocytic leukemia\n* Presence of detectable malignant cells in the CSF (cerebrospinal fluid), brain metastases, or history of central nervous system involvement by lymphoma.\n\nPresence of cardiac involvement by lymphoma.\n\n* Prior treatment for LBCL other than two cycles of R-chemotherapy.\n* History of severe immediate hypersensitivity reaction to any of the drugs used in this study.\n* Presence of central nervous system disorders: history of stroke, transient ischemic attack, or reversible posterior leukoencephalopathy syndrome (PRES) within 12 months prior to enrollment.\n* History of acute or chronic active hepatitis B or C infection, unless HBV-DNA and HCV-RNA levels are below the level of detection.\n* Human immunodeficiency virus (HIV) positivity, unless on appropriate antiretroviral therapy with undetectable viral load by PCR and a CD4 count \\> 200 cells\u002FµL.\n* Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.\n* History of clinically significant cardiac disease within 12 months prior to enrollment.\n* Any other condition deemed by the investigator as unsuitable for enrollment.",{"count":602,"type":21},60,[55],"The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma.",[59,606],"High-risk Large B-cell Lymphoma (LBCL)",[608,609,610],"axi-cel","car-t","LBCL",{"date":587,"type":35},{"date":613,"type":21},"2025-04-30",{"date":615,"type":21},"2028-04-09",{"name":617,"class":42},"Ruijin Hospital",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":43},"100558732","study-of-extracellular-vesicles-ev-in-patients-undergoing-car-t-cell-therapies-100558732","NCT06554951","Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies","Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapy","Inclusion Criteria:\n\n* patients affeccted by any hematological malignancies (r\u002Fr B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product;\n* age: 18 years or greater;\n* obtained written consent to the study participation.\n\nExclusion Criteria:\n\n* none","90 Years",{"count":243,"type":21},"Patients with refractory\u002Frelapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested.\n\nTherefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.",[59,629],"Extracellular Vesicles","2024-12-20",{"date":632,"type":35},"2024-12-27",{"date":634,"type":35},"2024-08-31",{"date":636,"type":21},"2026-08-31",{"name":638,"class":42},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]