[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,55,87,115,139,166,191,216,243,265,288,314],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100625550","phase-2-intratumoral-dnx-2401-for-high-grade-pediatric-brain-tumors-100625550",false,"NCT07424092","Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors","Intratumoral DNX-2401 Administration for Recurrent and Refractory High Grade Brain Tumors in Pediatric and Young Adult Patients","PED-DNX2401","Inclusion Criteria:\n\n* The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides writ-ten assent, where applicable, based on age and country requirements.\n* Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors \\[medulloblastomas, ATRT, EMTR, pineoblastoma\\], and ependymomas) diagnosis based on initial histopathological diagnosis and further clinical and radiological fol-low-up, in whom gross total resection is not feasible, and with a life expectancy of at least 16 weeks at the time of consent.\n* Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecutive MRI or if they occur at least 12 weeks after completion of ra-diation therapy, or if there is clear histopathological confirmation of tumor recurrence.\n* Male and female participants age ≥ 1 years and ≤ 25 years.\n* A single measurable lesion longer than 10 mm in two perpendicular diameters, considered by the investigator to be accessible for safe stereotactic biopsy and virus injection.\n* Lansky Performance Status (LPS) ≥ 60 for participants \\\u003C 16 years, or Karnofsky Performance Status (KPS) ≥ 60 for participants ≥ 16 years.\n* No other chemotherapy or immunotherapy in the 4 weeks before inclusion.\n* Steroids: free off or requiring decreasing or stable corticosteroid dose (≥ 0.05 mg\u002Fkg dexa-methasone daily, or equivalent for other steroids) in the 2 weeks before DNX-2401 admin-istration.\n* Radiation: no craniospinal irradiation, total body irradiation nor focal irradiation in the 6 weeks before inclusion.\n* Autologous Stem Cell Transplantation: patients must be ≥ 3 months post-transplant prior to entry of the study.\n* Patients must be fully recovered from all acute treatment related toxicities of all prior therapies.\n* Laboratory test: adequate hematological (platelets ≥ 100x10e9\u002FL, neutrophils ≥ 1.0x10e9\u002FL, hemoglobin ≥ 5,6 mmol\u002FL), renal function (creatinine \\\u003C1.5 times ULN) and liver function (≤3 times ULN) values.\n* Negative pregnancy test for female participants of child-bearing potential, where child-bearing potential is defined as a fertile female who is pubertal or post-pubertal and not permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy).\n* Female participants of child-bearing potential, who are sexually active, agree to use ac-ceptable birth control starting at informed consent and continuing for at least 120 days af-ter DNX-2401 administration. Male participants agree to use acceptable birth control start-ing at informed consent and continuing for at least 90 days after DNX-2401 administration.\n\nExclusion Criteria:\n\n* Any medical or psychological condition or disease that might interfere with the subject's ability to participate or give informed consent (if older than 16 years).\n* Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system.\n* Any treatment outside the allowable guidelines outlined in the inclusion criteria.\n* Severe acute infection or intercurrent medical condition including, but not limited to se-vere renal, hepatic, heart or bone marrow failure that based on investigator discretion do not permit inclusion in the study.\n* Subjects with immunodeficiency or autoimmune conditions, active hepatitis or known HIV. No testing for Hepatitis B, Hepatitis C and HIV is required unless mandated by local health authority.\n* Subjects with another primary malignancy.\n* Prior history of encephalitis, multiple sclerosis or other CNS infections or primary CNS dis-ease that would interfere with evaluation.\n* Li Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its relat-ed pathways.\n* Concurrent therapy with any antiviral drug or any immunosuppressive drug (except ster-oids).\n* Life or life-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted.\n* Prior participant in experimental viral therapy.\n* Inability to undergo MRI scans for any reason.\n* Pregnancy or breastfeeding.","ALL","1 Year","25 Years",{"count":21,"type":22},39,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401.\n\nThe main questions it aims to answer are:\n\n* Does a single intratumoral administration of DNX-2401 elicit tumor response and improve survival?\n* Is a single intratumoral administration of DNX-2401 safe and well tolerated?\n\nParticipants will:\n\n* Undergo surgery for tumor biopsy followed by a single intratumoral administration of DNX-2401\n* Visit the clinic periodically for checkups and tests",[28,29,30,31,32,33,34],"High Grade Glioma","Ependymoma","Embryonal Tumor of Brain","Recurrence","Refractory","Pediatric","Young Adult",[36,28,29,37,38,39,40,41],"High Grade Brain Tumors","Embryonal CNS Tumors","Recurrent or refractory","Pediatric and young adult patients","Oncolytic virus","DNX-2401","RECRUITING","2026-05-21",{"date":45,"type":46},"2026-05-27","ACTUAL",{"date":48,"type":46},"2026-05-12",{"date":50,"type":22},"2029-05",{"name":52,"class":53},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":74,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":54},"100605812","xdrive-for-florida-based-cancer-patients-100605812","NCT07167381","xDRIVE for Florida-based Cancer Patients","xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed\u002F Refractory Cancers","Inclusion Criteria:\n\n* Patients with recurrent\u002Frefractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)\n* -OR- Patients with recurrent\u002Frefractory cancer ≥18 years of age.\n* Patients who have received at least one prior line of standard of care therapy.\n* Patients able to provide treatment and outcome information from previous line(s) of therapy.\n* Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.\n* Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection.\n* Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling.\n\nExclusion Criteria:\n\n* Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and\u002For genetic profiling, defined as \\\u003C0.3g for resections or core\u002Ffine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.\n* Patients with insufficient health indicators to undergo therapeutic intervention.",{"count":63,"type":22},210,[65],"NA","Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).",[68,69,32,31,70,71,72,73],"Cancer","Neoplams","Leukaemia","Lymphoma","Solid Tumor Malignancies","Solid Cancers",[75,76],"Functional Precision Medicine","Artificial Intelligence","2026-05-17",{"date":79,"type":46},"2026-05-19",{"date":81,"type":46},"2025-11-01",{"date":83,"type":22},"2027-04-01",{"name":85,"class":86},"First Ascent Biomedical Inc.","INDUSTRY",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100630873","phase-1-genotype-guided-targeted-agents-plus-ezh2i-for-primary-refractory-ptcl-100630873","NCT07493330","Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL","Genotype-guided Targeted Agents in Combination With EZH2 Inhibitor, Zeprumetostat for Primary Refractory Peripheral T-cell Lymphoma (PTCL), a Prospective, Open-label, Multi-center Study","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Patients with a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) based on 2016 WHO classification\n* Previously treated with 3 or 6 cycles of a CHOP-like regimen as first-line therapy and considered primary refractory. Patients with anaplastic large cell lymphoma (ALCL) must have adequately received brentuximab vedotin (BV) as part of their first-line treatment.\n* Tumor tissue genotyping performed and results available prior to enrollment.\n* ECOG 0, 1, or 2.\n* Life expectancy greater than 3 months.\n* Adequate organ function\n* Contraception during study\n* Informed consented\n\nExclusion Criteria:\n\n* Has a prior malignancy other than the malignancies under study within 3 years without relieve\n* Primary CNS lymphoma\n* Known hypersensitivity to any study drug.\n* Pregnant or lactation\n* Active infection.\n* Diseases and medical history:\n\n  1. Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers\n  2. Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n  3. Has a history of psychoactive substance abuse that cannot be discontinued\n  4. Has any severe and\u002For uncontrolled disease.\n* Uncontrollable autoimmune disease,\n* Not able to comply to the protocol for mental or other unknown reasons\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.","18 Years",{"count":96,"type":22},86,[98,25],"PHASE1","To evaluate the safety and efficacy of Zeprumetostat-based combination therapy, selected according to genotyping results, in patients with primary refractory peripheral T-cell lymphoma (PTCL).",[101,32],"PTCL",[101,103,104,32],"Genotype-guided","Zeprumetostat","NOT_YET_RECRUITING","2026-04-01",{"date":108,"type":46},"2026-04-07",{"date":110,"type":22},"2026-03-23",{"date":112,"type":22},"2030-12-12",{"name":114,"class":53},"Ruijin Hospital",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":54},"100584653","phase-1-clinical-trial-of-cd19-targeted-car-t-cell-in-refractory-adult-sle-100584653","NCT06892145","Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE","Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)","Inclusion Criteria:\n\n1. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;\n2. Age ≥ 18 years old , gender not limited;\n3. Patients diagnosed with SLE according to the 2019 EULAR\u002FACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg\u002Fkg\u002Fd prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;\n4. SLEDAI-2K score ≥7 points;\n5. Autoantibody test results are positive: ANA antibody positive and\u002For serum anti-DSDNA positive;\n6. Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n   1. Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;\n   2. Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml\u002Fmin (Cockcroft Gault formula);\n   3. Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 3.0 × ULN in cases of combined liver infiltration);\n   4. Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);\n   5. Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.\n7. No serious mental disorders;\n8. Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;\n9. Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam\u002Fgel\u002Ffilm\u002Femulsion\u002Fsuppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.\n\nExclusion Criteria:\n\n1. There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;\n2. Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg\u002Fkg\u002F day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;\n3. There were other lupus crises that were not controlled at the time of screening;\n4. Individuals who have received CAR-T therapy or other gene modified cell therapies;\n5. Combined with other autoimmune diseases requiring systemic treatment;\n6. HBsAg or HBcAb positive and HBV DNA test greater than the normal range;HCV antibody positive and HCV RNA detection greater than the normal range;HIV antibody positive;Treponema pallidum antibody positive;\n7. Suffered from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;\n   3. History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n8. Uncontrollable infection in the 1 weeks before enrollment;\n9. History of solid organ transplantation or hematopoietic stem cell transplantation prior to screening；\n10. Cerebrovascular accident or seizure occurred within 6 months prior to screening；\n11. Deep vein or deep artery embolism event within the past 6 months prior to screening;\n12. history of malignant neoplasms (other than tumors with no active lesion and ending treatment \\> 2 years ago, and adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery);\n13. (attenuated) Live vaccine ≤ 4 weeks prior to screening;\n14. Have participated in other clinical trials within one month or five drug half lives (whichever is shorter) before enrollment;\n15. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving MC-1-50 cell infusion;\n16. Other situations considered by the investigator to be unsuitable to participate in the study.",{"count":5,"type":22},[98],"This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.",[126,32],"Systemic Lupus Erythematosus (SLE)",[128,129],"CAR T-Cell therapy","Systemic Lupus Erythematosus","2025-12-18",{"date":132,"type":46},"2025-12-22",{"date":134,"type":46},"2025-06-12",{"date":136,"type":22},"2028-02-16",{"name":138,"class":86},"Chongqing Precision Biotech Co., Ltd",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100615025","phase-1-the-safety-and-efficacy-of-daratumumab-in-patients-with-refractory-aplastic-anemia-100615025","NCT07287228","The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia","An Ib\u002FII Phase Clinical Study Evaluating the Safety and Preliminary Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia","DARA-AA-001","Inclusion Criteria:\n\n1. Clearly diagnosed with primary acquired aplastic anemia according to the Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition).\n2. Refractory aplastic anemia meeting one of the following criteria:\n\n   2.1 Patients previously diagnosed with severe aplastic anemia (SAA) # or transfusion-dependent non-severe aplastic anemia (TD-NSAA) \\&: have received antithymocyte\u002Fantilymphocyte globulin (ATG\u002FALG) combined with standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin (TPO) receptor agonist\\* therapy for at least 4 months, but showed no response or relapsed; 2.2 Patients previously diagnosed with non-transfusion-dependent non-severe aplastic anemia (NTD-NSAA): have received standard-dose cyclosporine for at least 6 months, and standard-dose thrombopoietin (TPO) receptor agonist\\* therapy for at least 4 months, but showed no response or relapsed.\n3. Hemoglobin \\\u003C90 g\u002FL or platelet count \\\u003C30×10⁹\u002FL.\n4. Not suitable for or unwilling to undergo hematopoietic stem cell transplantation; no other better treatment options available.\n5. Age ≥18 years, no sex limitation.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 (see Appendix 2).\n7. Voluntarily signed the informed consent form, understands the nature, purpose, and procedures of the trial, and is willing to comply with the trial requirements.\n\nExclusion Criteria:\n\n1. Patients with congenital bone marrow failure syndromes.\n2. Patients with bone marrow reticulin staining ≥ Grade 2.\n3. Patients with paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or with active hemolysis.\n4. Patients with clonal chromosomal abnormalities characteristic of myelodysplastic syndrome (MDS) (except +8, 20q-, and -Y).\n5. Presence of active bacterial, viral, or fungal infection within 2 weeks prior to the first administration of the investigational drug (excluding common cold and onychomycosis), or any other severe infection. Any anti-infective therapy for infections must be completed at least 2 weeks before the first dose. History of HIV infection or HIV antibody positive during screening; positive treponema pallidum antibody during screening; active pulmonary tuberculosis (evidenced by chest imaging or other relevant examinations within 3 months prior to first administration or during screening indicating active TB infection); active hepatitis during screening (positive hepatitis B surface antigen \\[HBsAg\\], or positive hepatitis B core antibody \\[HBcAb\\] with HBV DNA ≥30 IU\u002FmL, or positive hepatitis C antibody \\[HCV Ab\\] with positive HCV RNA).\n6. Presence of active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites.\n7. History of significant clinical diseases that, in the investigator's judgment, would pose a safety risk for the subject's participation or affect the evaluation of efficacy or safety if the disease\u002Fcondition worsens during the study. Examples include:\n\n   7.1 Cardiovascular disease: acute myocardial infarction or unstable angina within the past year, severe arrhythmias (such as frequent multifocal PVCs, ventricular tachycardia, ventricular fibrillation, etc.), congestive heart failure, arterial or venous thrombosis, NYHA Class III-IV cardiac function.\n\n   7.2 History of psychiatric disorders or severe cerebrovascular disease or cognitive sequelae.\n8. Use of B-cell or plasma-cell targeting agents within 3 months prior to the first administration of the investigational drug or expected use during the study period.\n9. Receipt of antithymocyte globulin or antilymphocyte globulin within 6 months prior to the first administration of the investigational drug.\n10. Treatment with tacrolimus, sirolimus, cyclophosphamide, anti-CD52 monoclonal antibodies, or similar agents within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration of the investigational drug.\n11. Planned participation in another clinical trial or prior exposure to another investigational product within less than 4 weeks or 5 half-lives (whichever is shorter) before the first dose.\n12. Vaccination with live attenuated vaccines within 4 weeks prior to the first administration of the investigational drug or planned during the study period, or COVID-19 vaccination within 7 days prior to first administration.\n13. Prior exposure to CD38-targeted therapy.\n14. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; female subjects of childbearing potential and male subjects with partners of childbearing potential who are unwilling to use highly effective contraception (see Appendix 3 for specific methods) throughout the study (from signing the ICF to 6 months after the last dose of study drug), or who plan to donate eggs or sperm during the study.\n15. Any other conditions deemed unsuitable for participation in this study by the investigator.",{"count":148,"type":22},37,[98,25],"This study consists of two phases, phase Ib and phase II. The primary objective of phase Ib is to evaluate the safety and tolerability of multiple doses of daratumumab in patients with refractory aplastic anemia. The primary objective of phase II is to preliminarily assess the efficacy of multiple doses of daratumumab in patients with refractory aplastic anemia. Secondary objectives include evaluation of other efficacy endpoints, safety (phase II), and pharmacodynamic characteristics of multiple doses of daratumumab in these patients. The exploratory objective is to assess biological functional changes in peripheral blood and bone marrow before and after daratumumab treatment.",[152,32,153],"Aplastic Anemia","Relapse",[155],"Aplastic anemia, Daratumumab","2025-12-16",{"date":158,"type":46},"2025-12-17",{"date":160,"type":22},"2025-12-10",{"date":162,"type":22},"2028-12-31",{"name":164,"class":53},"Institute of Hematology & Blood Diseases Hospital, China",1,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":165},"100615676","micropulse-laser-in-treatment-of-initial-and-refractory-cases-of-center-involved-diabetic-macular-edema-100615676","NCT07295704","Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20\u002F400 or better, and center-involved DME \\[defined as a central macular thickness (CMT) of \\>250 but \\\u003C700µm measured by spectral-domain optical coherence tomography\\].\n* Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).\n\nExclusion Criteria:\n\n* Monocular eyes.\n* Chronic renal failure or renal transplant because of diabetic nephropathy.\n* Glycated hemoglobin (HbA1c) of more than 10%.\n* Vitreomacular traction syndrome.\n* Epiretinal membrane.\n* PRP within 4months before the treatment.\n* Intraocular surgery within 6months, including cataract or vitreoretinal operation.\n* Rubeosis iridis.\n* Severe glaucoma.\n* High-risk proliferative diabetic retinopathy.\n* Poor dilation.\n* Increased foveal avascular zone.\n* Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.",{"count":174,"type":22},50,"OBSERVATIONAL","This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.",[178,179,180,32,181],"Micropulse Laser","Treatment","Initial","Center-Involved Diabetic Macular Edema","2025-12-06",{"date":132,"type":46},{"date":185,"type":46},"2025-10-15",{"date":187,"type":22},"2026-03-30",{"name":189,"class":190},"The General Authority for Teaching Hospitals and Institutes","NETWORK",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":165},"100523072","phase-1-atlcarcd30ccr4-for-cd30-hl-atlcarcd30ccr4-cells-100523072","NCT06090864","ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells","The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed\u002FRefractory CD30+ Hodgkin s Lymphoma","During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.\n\nInclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.\n\nExclusion Criteria:\n\n1. Subjects had major surgery within 28 days.\n2. Subject received investigational agents or tumor vaccines within 3 weeks.\n3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.",{"count":199,"type":22},31,[98,25],"Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity.\n\nThe majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib\u002FII study was conducted based on these observations.\n\nThe purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further.\n\nThis is a single-center, open-label phase Ib\u002FII trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.\n\nSubjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.",[203,153,32],"Hodgkin Lymphoma",[205,206],"cellular therapy","CD30+","2025-10-16",{"date":209,"type":46},"2025-10-20",{"date":211,"type":46},"2024-04-25",{"date":213,"type":22},"2031-07-01",{"name":215,"class":53},"UNC Lineberger Comprehensive Cancer Center",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":165},"100605259","long-term-evaluation-of-percutaneous-endoscopic-caecostomy-in-refractory-constipation-100605259","NCT07160192","Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation","Monocentric, Non-interventional Study Evaluating the Long-term Outcomes of Percutaneous Endoscopic Caecostomy (PEC) in Patients With Refractory Chronic Constipation","CONSTICAP 2","Inclusion Criteria:\n\n* Adult patient\n* Received PEC at CHU de Nantes\n* Affiliated to French social security\n* Non-opposition obtained\n\nExclusion Criteria:\n\n* No PEC placement\n* Protected adults or unable to respond\n* Refusal to participate",{"count":225,"type":22},80,"This observational monocentric study aims to evaluate the long-term effectiveness and tolerance of percutaneous endoscopic caecostomy (PEC) in patients with chronic refractory constipation. Follow-up data will be collected through phone interviews and standardized quality of life questionnaires.",[228,32],"Constipation",[230,231,228,232,233,234],"Caecostomy","Endoscopy","GIQLI","Long-term evaluation","SF-36","2025-08-29",{"date":237,"type":46},"2025-09-08",{"date":239,"type":22},"2025-09-01",{"date":209,"type":22},{"name":242,"class":53},"Nantes University Hospital",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":165},"100536493","multicenter-platform-type-clinical-study-of-refractoryrecurrent-acute-myeloid-leukemia-100536493","NCT06265545","Multicenter, Platform-type Clinical Study of Refractory\u002FRecurrent Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).\n\n  2\\. Meet criteria for refractory\u002Frecurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.\n\n  3\\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n1. Concurrent malignant tumors of other organs (patients requiring treatment).\n2. Participants considered unsuitable for inclusion by the researchers.",{"count":250,"type":22},120,[65],"To study the optimal therapeutic strategies for salvage treatment of refractory\u002Frelapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R\u002FR AML with different treatment regimens.",[254,32,255],"AML","Relapsed",[254,32,255],"2025-08-01",{"date":259,"type":46},"2025-08-06",{"date":261,"type":46},"2024-02-22",{"date":263,"type":22},"2026-06-30",{"name":164,"class":53},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":165},"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.","75 Years",{"count":274,"type":22},15,[98],"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)",[278,153,32,279],"Severe Aplastic Anemia","CAR T-cell Therapy","2025-07-23",{"date":282,"type":46},"2025-07-24",{"date":284,"type":46},"2025-06-19",{"date":286,"type":22},"2026-12-31",{"name":164,"class":53},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":17,"minAge":295,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":165},"100548692","early-phase-1-targeting-nudt21-sirna-drugs-for-patients-with-refractory-retinoblastoma-100548692","NCT06424301","Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma","Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma (A Prospective Pilot Study)","Inclusion Criteria:\n\n1. Patients with retinoblastoma with a somatic mutation of the gene RB1 and active tumor in a single eye, or germinal mutation of RB1 with active tumor\u002Fs in an eye and the contralateral eye unaffected, enucleated or without tumor activity. In both cases, relapsed or refractory with the use of systemic, intraarterial or intravitreal chemotherapy or radiotherapy, in accordance with the availability at his\u002Fher referral site, in whom enucleation is the only recommended treatment under opinion of the medical team treating the case at the originating referral site. But the patient has a strong desire to preserve the eye.\n2. Normal renal function: serum creatinine: \\\u003C 45 μmol\u002FL (0-2 years); \\\u003C 57 μmol\u002FL (3-6 years); \\\u003C 60 μmol\u002FL (7-10 years); \\\u003C 80 μmol\u002FL (11-13 years).\n3. Normal Hepatic function: serum ALT: \\\u003C 0,52 μkat\u002FL (de 9 months -12 years); serum AST: 61-80 g\u002FL (8 months - 5 years); 63-83 g\u002FL (5-9 years); 63-82 g\u002FL (9-12 years).\n4. Age greater than 6 months at the time of inclusion in the study.\n5. Sign the informed consent form and be willing to follow up at the specified time.\n\nExclusion Criteria:\n\n1. Presence of factors that require immediate enucleation of the affected eye such as glaucoma, rubeosis iridis, anterior chamber involvement.\n2. Comorbidities: Uncontrolled epilepsy with anticonvulsant treatment, cardiac disease not compensated by treatment.\n3. Active Infections.\n4. Other chronic or active acute diseases that under the criterion of the researcher were an exclusion criterion.\n5. History of having received attenuated or live vaccines in the 30 days prior to inclusion in the study.\n6. Any cause of Immunosuppression.\n7. Trilateral Retinoblastoma.\n8. Extraocular spread.\n9. History of having received treatment for retinoblastoma with chemotherapy or radiation therapy by any means within 30 days prior to inclusion in the study.\n10. Patients who can not complete the study procedures.","6 Months",{"count":54,"type":22},[298],"EARLY_PHASE1","Retinoblastoma (RB) is the most common intraocular malignancy in children, accounting for approximately 11% of all cancers diagnosed in children under the age of one. Although its incidence is relatively low-about 1 in 15,000 to 20,000 live births-RB has a high risk of intracranial metastasis via the optic nerve, often leading to poor prognosis in advanced cases.\n\nRecent advances in administration routes, such as intravitreal and intra-arterial chemotherapy, have significantly improved eye preservation rates. However, these strategies are limited by cumulative retinal toxicity and drug resistance. In refractory cases, enucleation remains the only definitive treatment to prevent extraocular spread and death.\n\nIn light of these challenges, current research efforts are focused on developing novel targeted therapies that enhance anti-tumor efficacy while minimizing local toxicity. In this context, we introduce a first-in-class siRNA-based drug targeting NUDT21, which promotes tumor regression by modulating the 3'UTR tail of SMC1A, thereby suppressing tumor cell proliferation. Importantly, the siRNA drug selectively targets tumor cells, offering a favorable safety profile compared to conventional chemotherapeutic regimens.\n\nGiven that both the target (NUDT21) and the mode of administration (intraocular siRNA injection) are novel in retinoblastoma treatment, there is an urgent need for early-phase investigator-initiated clinical research. This study is therefore designed to assess the short-term safety and preliminary efficacy of NUDT21 siRNA in patients with refractory retinoblastoma, and to provide an evidence base for future large-scale clinical trials.",[301,32],"Retinoblastoma",[303,304],"retinoblastoma","intravitreal Chemotherapy","2025-06-20",{"date":307,"type":46},"2025-06-26",{"date":309,"type":46},"2024-12-20",{"date":311,"type":22},"2025-09-30",{"name":313,"class":53},"Eye & ENT Hospital of Fudan University",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":272,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":165},"100572358","early-phase-1-a-dose-escalating-study-of-cd19cd22bcma-car-t-therapy-in-relapsed-refractory-multiple-myeloma-100572358","NCT06732232","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA CAR-T Therapy in Relapsed\u002F Refractory Multiple Myeloma","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Participants must meet all of the following criteria in order to be enrolled:\n\n  1. Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations\u002Fprocedures;\n  2. Age range: 18-75 years old;\n  3. Expected survival period is not less than 12 weeks;\n  4. ECOG score ≤ 2 points;\n  5. The bone marrow flow cytometry results showed positive BCMA antigen (including weak positive, moderate positive, and strong positive);\n  6. According to the IMWG criteria, a diagnosis of multiple myeloma with measurable lesions must meet at least one of the following criteria:\n\n     1. Serum M protein (SPEP) ≥ 5g\u002FL\n     2. 24-hour urinary M-protein excretion rate ≥ 0.2g (200mg)\n     3. Serum free light chain (sFLC) ≥ 100 mg\u002FL and abnormal free light chain ratio\n     4. The ratio of primitive plasma cells to immature plasma cells in bone marrow cytology examination is greater than 5%, or the flow cytometry detection of monoclonal plasma cells is greater than 5%\n  7. Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed, and have experienced relapse (within 12 months), difficulty in treatment, or intolerance to the last line treatment regimen, including primary difficulty in treatment (subjects who have not achieved minimal remission \\[MR\\] or developed disease progression \\[PD\\] during treatment) or secondary difficulty in treatment (subjects who develop disease progression within 60 days after completion of treatment);\n  8. There is no significant abnormality in lung function, and the oxygen saturation is greater than 92% in the absence of oxygen inhalation;\n  9. The blood biochemistry test results meet the following criteria:\n\n     1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)\n     2. Total bilirubin ≤ 1.5 × ULN\n     3. 24-hour serum creatinine clearance rate ≥ 30 mL\u002Fmin\n     4. Lipase and amylase ≤ 2 × ULN\n  10. The blood routine test meets the following criteria:\n\n      1. Lymphocyte count\\>0.5 × 10 \\^ 9\u002FL\n      2. Neutrophil count ≥ 1.0 × 10 \\^ 9\u002FL\n      3. Hemoglobin ≥ 60g\u002FL\n      4. Platelets ≥ 40 × 10 \\^ 9\u002FL\n  11. Men with fertility and women of childbearing age must agree to use effective contraceptive measures from the signing of the informed consent form until 2 years after the use of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test for women of childbearing age must be negative during screening.\n\nExclusion Criteria:\n\n* Any of the following situations cannot be selected as a subject:\n\n  1. Asymptomatic (smoking type) multiple myeloma;\n  2. Multiple myeloma with only extramedullary lesions present;\n  3. Plasma cell leukemia;\n  4. Merge amyloidosis;\n  5. Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression;\n  6. Pregnancy or lactation period;\n  7. Individuals who are HBsAg positive or HBcAb positive, unless HBV-DNA is less than 100 IU\u002Fml or below the minimum detectable value; Individuals who are positive for hepatitis C virus (HCV) antibodies and HCV-RNA; Individuals who are HIV antibody positive; Individuals who are positive for syphilis specific antibodies and have a positive TRUST (toluidine red unheated serum test) test; Individuals who test positive for Cytomegalovirus (CMV) DNA;\n  8. Cardiovascular diseases with clinical significance, including any of the following:\n\n     1. QT interval (QTcF) after heart rate correction:\\>470 milliseconds;\n     2. New York Heart Association Grade II and above heart failure;\n     3. Left ventricular ejection fraction (LVEF) ≤ 50%;\n     4. Poorly controlled hypertension (systolic blood pressure ≥ 150 mm Hg and\u002For diastolic blood pressure ≥ 95 mm Hg)\n     5. Arrhythmias that have clinical significance or require antiarrhythmic treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion tachycardia, and complete left bundle branch block);\n  9. Has experienced unstable angina or acute myocardial infarction within the 6 months prior to signing the ICF;\n  10. Previously received any anti-CD45 or anti-CD3 treatment;\n  11. Individuals who are allergic to any of the components of the drugs used in this study, including but not limited to Qing Lin drugs (cyclophosphamide, fludarabine), etc;\n  12. Received any investigational drug or systemic anti-tumor treatment within 4 weeks (or 5 half lives of the drug, whichever the researcher deems more appropriate) prior to single collection;\n  13. History of other primary malignant tumors within 5 years prior to treatment, except for the following situations:\n\n      1. Fully treat cured cervical carcinoma in situ;\n      2. Localized basal cell carcinoma or squamous cell carcinoma of the skin;\n  14. Any uncontrolled active infection within 4 weeks prior to single collection requires parenteral antibiotics, antiviral or antifungal treatment;\n  15. Individuals with a history of active pulmonary tuberculosis infection within one year prior to single sampling (excluding subjects with a history of active pulmonary tuberculosis infection more than one year ago who, according to the researcher's judgment, currently have no evidence of active pulmonary tuberculosis);\n  16. Accompanying or having a history of interstitial lung disease or interstitial pneumonia;\n  17. Subjects who receive autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of signing the ICF, or who plan to undergo ASCT during the study period;\n  18. Subjects who have received allogeneic stem cell therapy in the past; The researchers believe that complications or other conditions in the subjects may affect their compliance with the protocol or make them unsuitable to participate in this study.",{"count":5,"type":22},[298],"This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19\u002FCD22\u002FBCMA in patients with relapsed\u002Frefractory multiple myeloma.",[255,32,325],"Multiple Myeloma",[327,328,329,330,331],"relapsed\u002Frefractory multiple myeloma","CAR-T","CD19","CD22","BCMA","2024-12-11",{"date":334,"type":46},"2024-12-13",{"date":336,"type":46},"2024-12-12",{"date":338,"type":22},"2027-12-12",{"name":340,"class":86},"Shanghai Cell Therapy Group Co.,Ltd"]