[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-thrombocytopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-thrombocytopenia":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,42,67,92,116,146,168,191,216,240,262,279,299,317,341,364,389,413,435,454,474,491,514,533,551],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100593555","phase-3-study-to-evaluate-the-efficacy-and-safety-of-oral-rilzabrutinib-in-adults-with-immune-thrombocytopenia-itp-who-failed-first-line-treatment-100593555",false,"NCT07007962","Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment","A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment","LUNA 4","Key Inclusion Criteria:\n\n* Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history\n* Participant received at least one course of first-line therapy and had a history of response while on treatment\n* Participant has loss of response, relapse, or steroid dependency\n\nKey Exclusion Criteria:\n\n* Participants with Secondary ITP\n* Participants with Evans syndrome or history of myelodysplastic syndrome\n* Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.\n* Participants with history of solid organ transplant\n* Participants with history of coagulation or bleeding disorders other than ITP, including genetic conditions, other than ITP\n* Participant received advanced therapy for ITP or was splenectomized\n* Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.",[28],"Immune Thrombocytopenia","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":33},"2025-10-24",{"date":37,"type":22},"2028-12-30",{"name":39,"class":40},"Sanofi","INDUSTRY",36,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100641232","phase-2-sirolimus-in-patients-with-systemic-lupus-erythematosus-associated-immune-thrombocytopenia-100641232","NCT07657793","Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia","A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia","Inclusion Criteria:\n\nAge ≥ 18 and \\\u003C 65 years\n\n1. Meet 2012 SLICC or 2019 EULAR\u002FACR criteria for systemic lupus erythematosus\n2. Meet ITP diagnostic criteria: platelet count ≤ 30×10\\^9\u002FL, or ≤ 50×10\\^9\u002FL with bleeding tendency\n3. At least two CBC tests showing thrombocytopenia\n4. Bone marrow smear showing megakaryocyte maturation disorder\n5. Willing to sign informed consent form\n\nExclusion Criteria:\n\n1. Other causes of thrombocytopenia\n2. Refractory SLE-ITP (no partial response after 3 months of high-dose steroids or immunosuppressants)\n3. Use of rituximab within 6 months\n4. Severe organ involvement (e.g., proteinuria \\> 1g\u002F24h, CNS involvement, cardiac\u002FGI involvement)\n5. Other autoimmune diseases (except Sjögren's syndrome)\n6. Malignancy\n7. Active infections (HIV, HBV, HCV, syphilis)\n8. Severe liver or kidney dysfunction\n9. Splenomegaly\n10. Pregnancy or breastfeeding\n11. Contraindications to study drugs\n12. Unhealed major wounds or incisions\n13. Judged unsuitable by investigator","65 Years",{"count":51,"type":22},164,[53,25],"PHASE2","The goal of this clinical trial is to learn if sirolimus, added to standard background therapy (corticosteroids and hydroxychloroquine), works to treat systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP) in adults aged 18 to 65 years. The study also aims to evaluate the long-term effectiveness and safety of sirolimus over 48 weeks.\n\nThe main questions it aims to answer are:\n\n1. Does sirolimus increase the overall response rate (complete or partial remission of thrombocytopenia) at 24 weeks compared with placebo?\n2. The safety issues when taking sirolimus over 24 weeks (Phase 1) and up to 48 weeks (Phase 2).\n3. How long does the treatment effect last, and what is the relapse rate during open-label extension? In Phase 1 (first 24 weeks), researchers will compare sirolimus to a placebo (an identical-looking capsule containing no active drug) to see if sirolimus works to treat SLE-ITP when both groups also receive standardized prednisone and hydroxychloroquine. In Phase 2 (weeks 24 to 48), all participants will receive open-label sirolimus to assess long-term efficacy and safety.\n\nParticipants will:\n\n1. Phase 1: Take sirolimus (1.5 mg once daily) or a placebo for 24 weeks, plus standardized prednisone (tapered according to protocol) and hydroxychloroquine (0.4 g daily)\n2. Phase 2: After completing Phase 1, take open-label sirolimus (1.5 mg once daily) for an additional 24 weeks, continuing stable or tapering doses of prednisone and hydroxychloroquine\n3. Visit the clinic at screening, baseline, weeks 4, 12, 24 (end of Phase 1), and then at weeks 28, 36, and 48 (end of Phase 2) for checkups, blood tests, and disease activity assessments\n4. Receive telephone follow-ups at weeks 8, 16, 20, 32, 40, and 44 to report platelet counts, medication adherence, and adverse events",[56,28],"Systemic Lupus Erythematosus","2026-06-15",{"date":30,"type":33},{"date":60,"type":33},"2026-06-07",{"date":62,"type":22},"2029-09-30",{"name":64,"class":65},"Chinese SLE Treatment And Research Group","OTHER",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100642758","a-real-world-study-of-treatment-patterns-and-outcomes-in-primary-immune-thrombocytopenia-patients-treated-with-eltrombopag-100642758","NCT07587723","A Real-world Study of Treatment Patterns and Outcomes in Primary Immune Thrombocytopenia Patients Treated With Eltrombopag","Real-world Treatment Patterns and Outcomes of Eltrombopag in Patients With Primary Immune Thrombocytopenia","Inclusion criteria:\n\nHCP inclusion criteria:\n\n1. A licensed HCP (e.g., internal medicine specialist, hematologist, hematologist-oncologist or immunologist etc.) involved in the management of adult patients with primary ITP.\n2. Actively involved in treatment decision-making for primary ITP patients at the time of the study.\n3. Have a minimum of 3 years of experience managing patients with primary ITP.\n4. Currently, managing an average of at least 2 adult primary ITP patients per month, including those treated with eltrombopag.\n5. Able and willing to complete a web-based survey (approximately 60 to 70 minutes) and abstract data from 2 eligible patient charts.\n6. Practicing in one of the study countries (US, UK, or Germany).\n7. Have access to a computer or mobile device with internet connectivity to complete the survey.\n8. Not listed as inactive or retired in the panel database.\n\nPatient-level inclusion criteria:\n\n1. Confirmed diagnosis of primary ITP.\n2. Aged ≥18 years at the time of diagnosis.\n3. Received first-line corticosteroid therapy (with or without intravenous immune globulin \\[IVIg\\]).\n4. Initiated eltrombopag treatment (with or without corticosteroids) as first non-steroidal ITP treatment between 01 January 2020 and 31 December 2024.\n5. Have at least 6 months of follow-up data available after the index date (unless deceased within that period).\n\nExclusion criteria:\n\nHCP exclusion criteria:\n\n1. Currently employed by a pharmaceutical company or regulatory authority involved in the approval or marketing of treatments for primary ITP.\n2. Unable to provide data for patients who meet the study's inclusion criteria.\n3. Not currently managing patients with primary ITP or are not involved in treatment decisions for these patients.\n\nPatient-level exclusion criteria:\n\n1\\. Diagnosis of Evans syndrome, secondary ITP, or non-immune thrombocytopenia.","100 Years",{"count":76,"type":22},150,"OBSERVATIONAL","This study aims to describe the treatment patterns and clinical outcomes of treatment with eltrombopag in primary immune thrombocytopenia (ITP) patients treated with prior corticosteroid therapy.\n\nThis study will use secondary data provided by health care professionals (HCPs) for a sample of primary ITP patients, and primary data from a structured HCP survey. Data will be collected from HCPs working in various clinical centers across the United States (US), United Kingdom (UK), and Germany.",[28],[81,82],"Primary Immune Thrombocytopenia","Eltrombopag","NOT_YET_RECRUITING","2026-06-12",{"date":57,"type":33},{"date":87,"type":22},"2026-06-23",{"date":89,"type":22},"2028-09-29",{"name":91,"class":40},"Novartis Pharmaceuticals",{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100600982","phase-2-study-to-assess-the-safety-and-tolerability-of-tafasitamab-in-adult-participants-with-primary-autoimmune-blood-cell-disorders-100600982","NCT07104565","Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders","A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders","Inclusion Criteria:\n\n\\- Ability to comprehend and willingness to sign a written ICF for the study.\n\n* Aged ≥ 18 years.\n* Confirmed historical diagnosis of one of the following autoimmune blood disorders:\n\n  * Primary ITP.\n  * Primary wAIHA.\n* No history of splenectomy.\n* Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab):\n\n  * Primary ITP: Increase in platelet count to ≥ 30 × 109\u002FL with at least a 2-fold increase of baseline platelet count.\n  * Primary wAIHA: Increase in hemoglobin to ≥ 10 g\u002FdL with an increase of at least 2 g\u002FdL from baseline.\n* Received ≥ 1 standard course of rituximab (375 mg\u002Fkg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible.\n\n  * Primary ITP: a PR (platelet count ≥ 30 × 109\u002FL with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count \\> 100 × 109\u002FL) lasting \\\u003C 48 weeks OR NR (platelet count \\\u003C 30 × 109\u002FL or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose.\n  * Primary wAIHA: a PR with hemoglobin ≥ 10 g\u002FdL and with an increase of at least 2 g\u002FdL from baseline OR a CR (hemoglobin ≥ 12 g\u002FdL and normalization of hemolytic markers) OR NR (hemoglobin \\\u003C 10 g\u002FdL or \\\u003C 2 g\u002FdL increase of baseline hemoglobin).\n* Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion.\n\n  * Primary ITP: platelet count \\\u003C 30 × 109\u002FL within the 15 days before treatment is scheduled to begin (Day 1).\n\nNote: Participants treated with a rescue therapy during screening in response to a documented platelet count \\\u003C 30 × 109\u002FL are eligible, irrespective of platelet count within 15 days of Day 1.\n\n• Primary wAIHA: hemoglobin \\\u003C 10 g\u002FdL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and\u002For indirect bilirubin.\n\n* ECOG performance status of 0 to 2.\n* Willingness to avoid pregnancy or fathering children.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Clinical manifestations typical for cold agglutinin disease.\n* Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin \\\u003C 6 g\u002FdL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.\n* Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.\n* Previous severe allergic reaction to a mAb or known allergy to any component\u002Fexcipient of tafasitamab.\n* Changes in doses (\\> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.\n* Evidence of hypogammaglobulinemia during screening (IgA \\\u003C 70 mg\u002FdL, IgG \\\u003C 700 mg\u002FdL, and\u002For IgM \\\u003C 40 mg\u002FdL) and frequent and\u002For severe infections.\n* Women who are pregnant or breastfeeding.\n* History of malignancy except for the following:\n\n  * Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening.\n  * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer.\n  * Adequately treated carcinoma in situ without current evidence of disease.\n* Congestive heart failure (left ventricular ejection fraction of \\\u003C 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan).\n* Participants with:\n\n  * Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA.\n\nNote: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result.\n\n• Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result).\n\nNote: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines.\n\nNote: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible.\n\n• Seropositivity for or history of active viral infection with HIV.\n\n* Active systemic infection (including infection with SARS-CoV-2).\n* Participants in a severely immunocompromised state, per investigator's clinical assessment.\n* Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable).\n* Coagulation or platelet function abnormality.\n* An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months).\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment\u002Fenrollment (except for chronic toxicities \\[≤ Grade 2\\] not expected to resolve).\n* Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications.\n* Unwillingness to undergo transfusion with blood components.\n* Current use of prohibited medication as described in the protocol.\n* Inadequate recovery from toxicity and\u002For complications from a major surgery before starting therapy.\n* Further exclusion criteria apply.",{"count":100,"type":22},56,[53],"This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.",[28],[105,106,107],"primary warm autoimmune hemolytic anemia","primary immune thrombocytopenia","anti-CD19 monoclonal antibody",{"date":109,"type":33},"2026-06-16",{"date":111,"type":33},"2025-12-29",{"date":113,"type":22},"2028-03-09",{"name":115,"class":40},"Incyte Corporation",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":66},"100423943","contribution-of-anti-platelet-antibodies-identified-with-maipa-assay-in-the-demonstration-of-the-auto-immune-character-of-a-thrombocytopenia-at-diagnosis-100423943","NCT04800458","Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis","Contribution of Anti-platelet Antibodies Identified With\" Monoclonal Antibody Immobilization of Platelet Antigens\" Assay (MAIPA) in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis","APAT","Inclusion Criteria:\n\n* Patient over 18 years old;\n* Patients with thrombocytopenia \\\u003C100 G\u002FL, checked twice, having ruled out false thrombocytopenia by platelet aggregation and acute leukemia by smear;\n* No treatment started;\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research);\n* Person affiliated or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Secondary ITP;\n* False thrombocytopenia;\n* Patients who have been transfused with platelets for less than 7 days with efficacy;\n* Patient treated for thrombocytopenia (48 hours of corticosteroid therapy is tolerated and is not an exclusion criteria);\n* Patient with acute leukemia;\n* Pregnant or breastfeeding woman;\n* False thrombocytopenia;\n* Patient under guardianship, curatorship or any other legal protection regime.",{"count":125,"type":22},225,[127],"NA","Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the \"monoclonal antibody immobilization of platelet antigens\" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.",[130,28,131],"Thrombocytopenia","Myelodysplasia",[133,134,135,136],"Monoclonal antibody immobilization of platelet antigens assay","MAIPA","Anti-platelet antibodies","Thrombopoietin","2026-05-29",{"date":139,"type":33},"2026-06-01",{"date":141,"type":33},"2021-05-19",{"date":143,"type":22},"2028-05",{"name":145,"class":65},"University Hospital, Bordeaux",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":66},"100608838","phase-1-phase-i-study-of-shr-2173-injection-in-patients-with-primary-immune-thrombocytopenia-100608838","NCT07206758","Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia","A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).\n2. Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.\n3. Confirmed diagnosis of primary ITP for at least 3 months at screening.\n4. Previous treatment with corticosteroids.\n5. At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.\n6. Platelet count \\\u003C30×10⁹\u002FL at screening with clinical assessment indicating treatment necessity\n7. Participants must have adequate organ function\n8. Clinically stable condition with World Health Organization (WHO) bleeding scale grade 0-1\n9. Female participants of childbearing potential or male participants with fertile partners must refrain from sperm\u002Fova donation from ICF signing until 12 weeks after last dose and agree to protocol-specified contraceptive measures\n\nExclusion Criteria:\n\n1. Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia\n2. Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173\n3. Received immunosuppressants (other than corticosteroids) such as Janus kinase \\[JAK\\] inhibitors or Bruton tyrosine kinase \\[BTK\\] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the first infusion of SHR-2173 (whichever is longer)\n4. Previous treatment with SHR-2173\n5. Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and\u002For receiving antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel, novel oral anticoagulants), except for low-dose acetylsalicylic acid\n6. History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia\n7. Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization\n8. Active viral, bacterial, or other infections (including tuberculosis \\[TB\\]) requiring systemic treatment at screening, or SARS-CoV-2 infection during screening, or history of clinically significant recurrent infections\n9. Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live\u002Fattenuated vaccinations during the trial\n10. Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live\u002Fattenuated vaccinations during the trial\n11. Diagnosis of myelodysplastic syndrome; history of or current malignancy within 5 years prior to screening (except for cured non-melanoma skin cancer, in situ carcinoma \\[e.g., cervical, breast, bladder, prostate cancer\\], and cancers in complete remission for at least 5 years with no evidence of recurrence)\n12. Previous splenectomy\n13. Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression\n14. Planned surgery during the dosing period\n15. Any severe and\u002For unstable pre-existing medical, psychiatric, or other conditions that the investigator judges may interfere with patient safety, obtaining informed consent, or compliance with study procedures\n16. Allergic constitution (e.g., allergies to two or more drugs, foods, or pollens) or known hypersensitivity (immediate or delayed) or atopic reactions to the study drug (including excipients, monoclonal antibodies)\n17. Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)\n18. Females who are lactating or pregnant (positive serum or urine β-human chorionic gonadotropin \\[hCG\\]) at screening or on Day 1 of Week 1 prior to administration",{"count":154,"type":22},10,[156],"PHASE1","Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients",[28],"2026-05-26",{"date":161,"type":33},"2026-05-28",{"date":163,"type":33},"2025-11-12",{"date":165,"type":22},"2026-11",{"name":167,"class":40},"Guangdong Hengrui Pharmaceutical Co., Ltd",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":66},"100638897","phase-1-safety-and-efficacy-of-gl-2045-in-patients-with-immune-thrombocytopenia-100638897","NCT07605845","Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia","Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia","Key Inclusion Criteria:\n\n1. Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.\n2. Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.\n3. A platelet count of 10 to 49 × 10\\^9\u002FL at baseline.\n4. Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.\n5. The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.\n\nKey Exclusion Criteria:\n\n1. Any serious adverse event (SAE) with prior IVIg dosing.\n2. Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.\n3. Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.\n4. Abnormal organ function including liver and kidney.\n5. Any previous or current treatments prohibited by the protocol.\n6. Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).","80 Years",{"count":177,"type":22},42,[156],"The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).",[28],[182],"Adult ITP","2026-05-18",{"date":159,"type":33},{"date":186,"type":33},"2026-04-14",{"date":188,"type":22},"2027-12-06",{"name":190,"class":40},"Gliknik Inc.",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":66},"100640170","phase-1-universal-star-t-cell-injection-in-rr-autoimmune-diseases-100640170","NCT07599280","Universal STAR-T Cell Injection in R\u002FR Autoimmune Diseases.","An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Confirmed diagnosis of a connective tissue disease (CTD) according to the latest international classification criteria, including but not limited to Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Antiphospholipid Syndrome (APS), and Undifferentiated Connective Tissue Disease (UCTD).\n3. Confirmed diagnosis of CTD-associated immune thrombocytopenia meeting one of the following:\n\n   Platelet count \\\u003C 30 × 10⁹\u002FL; Platelet count \\\u003C 50 × 10⁹\u002FL accompanied by bleeding tendency.\n4. Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP).\n5. Prior Treatment History: Failure to achieve partial remission (PR) after receiving at least one of the following regimens continuously for ≥ 3 months, or inability to maintain efficacy during glucocorticoid tapering:\n\nAt least one course of glucocorticoid pulse therapy; Or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics).\n\n6\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL\n\n   ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 7. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n8\\. Voluntary participation with signed informed consent and compliance.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  12. Pregnant women or women planning to become pregnant;\n  13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":199,"type":22},6,[156],"This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.\n\nThis study evaluates the safety and efficacy of universal STAR-T cells in patients with R\u002FR CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells\u002Fkg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.",[28],[204,205,206],"CTD","Relapsed Refractory","Autoimmune","2026-05-14",{"date":209,"type":33},"2026-05-20",{"date":211,"type":22},"2026-05-11",{"date":213,"type":22},"2028-05-11",{"name":215,"class":65},"Jian Zhu",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":238,"locationsCount":66},"100640893","phase-3-atra-for-management-of-primary-itp-100640893","NCT07597395","ATRA for Management of Primary ITP","All-trans Retinoic Acid for Management of Primary Immune Thrombocytopenia : a Randomized, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n* Primary ITP if aged ⩾18 years;\n* With an average of two platelet counts ⩾1 day apart of \\\u003C30×10\\^9\u002FL during screening and no single platelet count \\>35×10\\^9\u002FL within 2 weeks before study treatment;\n* Patients who have previously received at least one first-line standard therapy for ITP (corticosteroid and\u002For intravenous immunoglobulin) with unsustained efficacy, relapse, intolerance to standard therapy, or insufficient response.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;\n* With active malignancy or a history of malignant tumor;\n* Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;\n* With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;\n* Active or chronic HBV, HCV or HIV infection;\n* Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;\n* Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;\n* Prior ATRA therapy;\n* History of solid organ transplant or planned surgery;\n* Myelodysplastic syndrome, aplastic anemia or myelofibrosis;\n* Patients with other diseases were undergoing treatment with immunosuppressants;\n* Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;\n* History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;\n* History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric or any other severe and\u002For unstable diseases that, in the opinion of the investigator, may pose an unacceptable risk with the investigational product or interfere with the interpretation of study data;\n* AST \\> 2 times the upper limit of normal (ULN), ALT \\> 2×ULN, TBIL ≥ 1.5×ULN;\n* WBC \\\u003C 2500\u002FµL, neutrophil count \\\u003C 1200\u002FµL, lymphocyte count \\\u003C 750\u002FµL, hemoglobin \\\u003C 9 g\u002FdL;\n* eGFR \\\u003C 50 mL\u002Fmin\u002F1.73m²;\n* Other patients deemed unsuitable for enrollment in this study by the investigator.",{"count":224,"type":22},192,[25],"A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant\u002Frelapsed primary immune thrombocytopenia (ITP).",[28],[229,230,231],"Immune thrombocytopenia;","Corticosteriod resistance resistant\u002Frelaped","ATRA","2026-05-13",{"date":234,"type":33},"2026-05-19",{"date":236,"type":22},"2026-05-30",{"date":37,"type":22},{"name":239,"class":65},"Peking University People's Hospital",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":66},"100615819","phase-2-anti-cd38-monoclonal-antibody-versus-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100615819","NCT07297563","Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10\\^9\u002FL) to standard first-line treatment of ITP (glucocorticoid and\u002For intravenous immunoglobulin).\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":248,"type":22},160,[53],"This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[28,252],"Treatment","2026-02-09",{"date":255,"type":33},"2026-02-11",{"date":257,"type":33},"2026-01-20",{"date":259,"type":22},"2027-11",{"name":261,"class":65},"Institute of Hematology & Blood Diseases Hospital, China",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":66},"100610933","phase-2-rituximab-combining-anti-cd38-monoclonal-antibody-versus-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100610933","NCT07234019","Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 48 hours prior to the first dose of the study drug;The platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse).\n* Previous emergency treatment for ITP (e.g., methylprednisolone, platelet, gamma globulin infusion) must have been completed at least 2 weeks before the first dose.\n* Hepatic and renal function (e.g., alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatinine) \\\u003C1.5 times the upper limit of normal (ULN).\n* ECOG performance status score of ≤2.\n* Cardiac function: New York Heart Association (NYHA) class ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists, but the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug; Azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first dose; CD20 monoclonal antibody such as rituximab must have been stopped for more than 6 months; the interval between splenectomy and first administration need to be more than 6 months.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 90 days after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases.\n* HIV positive.\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive.\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc..\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled.\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis.\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past.\n* atients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up.\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared.\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.).\n* Patients with septicemia or other irregular severe bleeding.\n* Patients taking antiplatelet drugs at the same time.\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.\n* Subjects with a known allergy to medications were used in the trial or excipients.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":248,"type":22},[53],"This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[28,252],{"date":255,"type":33},{"date":275,"type":33},"2026-01-28",{"date":277,"type":22},"2028-11",{"name":261,"class":65},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":66},"100620790","phase-2-anti-cd38-monoclonal-antibody-combined-with-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100620790","NCT07362199","Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Single-arm, Open-label Phase II Clinical Study Evaluating the Efficacy of Rituximab Combined With Anti-CD38 Monoclonal Antibody in the Treatment of Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Subjects have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Subjects have failed at least one prior thrombopoietin receptor agonist therapy (such as rhTPO, eltrombopag, hetrombopag, etc.) in second-line treatment, as well as rituximab\u002Fanti-CD38 monoclonal antibody therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Alternatively, subjects have experienced treatment failure or post-splenectomy relapse following splenectomy.\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects allergic to CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have been treated with CD20 monoclonal antibodies (e.g., rituximab), CD38 monoclonal antibodies, cyclophosphamide, vindesine, or similar medications within 3 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":287,"type":22},20,[53],"This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[28,252],"2026-01-15",{"date":293,"type":33},"2026-01-23",{"date":295,"type":22},"2026-03",{"date":297,"type":22},"2027-03",{"name":261,"class":65},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":19,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":66},"100620793","phase-2-daratumumab-versus-rituximab-in-the-management-of-pediatric-primary-immune-thrombocytopenia-itp-100620793","NCT07362238","Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥6，\\\u003C18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10\\^9\u002FL) to standard first-line treatment of ITP (glucocorticoid and\u002For intravenous immunoglobulin).\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* Subjects and the legal guardian comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.","6 Years",{"count":308,"type":22},122,[53],"This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[28,252],{"date":293,"type":33},{"date":295,"type":22},{"date":315,"type":22},"2028-03",{"name":261,"class":65},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":326,"studyType":77,"phases":4,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":66},"100276392","french-registry-of-adult-patients-with-immune-thrombocytopenia-and-autoimmune-hemolytic-anemia-100276392","NCT02877706","French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia","CARMEN","Inclusion Criteria:\n\n* adult patients (18+ year-old)\n* newly diagnosed for ITP\u002FAIHA or initiation of FOSFAMATINIB\n\nExclusion criteria:\n\n\\- opposition to data collection",{"count":325,"type":22},1500,"15 Years","CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.",[28,329],"Autoimmune Hemolytic Anemia",[331],"Registry","2025-12-23",{"date":334,"type":33},"2025-12-31",{"date":336,"type":4},"2013-06",{"date":338,"type":22},"2029-12",{"name":340,"class":65},"University Hospital, Toulouse",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100617188","phase-1-optimal-dose-of-zanubrutinib-to-treat-adult-immune-thrombocytopenia-100617188","NCT07315373","Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia","The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Confirmed newly-diagnosed, treatment-naive ITP;\n2. Platelet counts \\\u003C30×10\\^9\u002FL ;\n3. Platelet counts \\\u003C 50×10\\^9\u002FL and significant bleeding symptoms (WHO bleeding scale 2 or above);\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;\n2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;\n3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;\n4. Active infection;\n5. Maligancy;\n6. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);\n7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy\n8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;\n9. Patients who are deemed unsuitable for the study by the investigator.","70 Years",{"count":21,"type":22},[156],"The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.",[28],[354,355],"ITP","zanubrutinib","2025-12-18",{"date":358,"type":33},"2026-01-02",{"date":360,"type":22},"2025-12-25",{"date":362,"type":22},"2029-06-30",{"name":239,"class":65},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":66},"100609265","a-study-of-cd19-ucar-t-cells-in-subjects-with-autoimmune-diseases-100609265","NCT07212322","A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","A Study to Evaluate the Safety and Efficacy of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","ET-902-AID01","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years old;\n* Adequate organ functions, defined as follows:\n\nHematological function \\[no transfusion and no use of granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to testing\\]: white blood cells (WBC) ≥3.0×10\\^9\u002FL, absolute neutrophil count (ANC)≥1.0×10\\^9\u002FL, platelet count (PLT)≥50×10\\^9\u002FL (ITP subjects are without restrictions), hemoglobin ≥80 g\u002FL.\n\nCoagulation function: international normalized ratio (INR) ≤ 1.5×upper limit of normal value （ULN）, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\nHepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×(ULN), and total bilirubin ≤1.5×ULN. 4)Renal function: serum creatinine ≤1.5×ULN or creatinine clearance (calculated by Cockcroft Gault formula) ≥ 40 ml\u002Fmin.\n\nCardiac function: New York Heart Association (NYHA) Grade I or II, and left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO), with no pericardial effusion, and no clinically significant abnormalities on12-lead electrocardiogram (ECG).\n\nPulmonary function: oxygen saturation ≥92% on room air (without supplemental oxygen), no clinically significant pleural effusion.\n\n* Subjects with fertile partners must agree to use effective contraception throughout the treatment period and for 24 months after treatment, and must refrain from donating eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing potential (excluding those who have undergone sterilization or ≥12 months of menopause) must have negative urine or blood pregnancy test results during screening.\n* Voluntary participates this trial and can comprehend and sign ICF.\n* For subjects with moderate to severe refractory Systemic Lupus Erythematosus:\n\nDiagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n\nPositive for antinuclear antibody (ANA) (titer ≥1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening.\n\nSLEDAI-2000 score ≥8 at screening; if points are attributed for low complement and\u002For anti-dsDNA antibody, the SLEDAI-2000 clinical symptom score (excluding points for low complement and\u002For anti-dsDNA antibody) must be ≥6.\n\nA history of at least 6 months of stable standard treatment regimen prior to screening, with failure to achieve LLDAS criteria for at least 2 months before screening. Standard treatment regimen refers to stable use of any of the following medications (alone or in combination):\n\nglucocorticoids, antimalarials, biologics, and other immunosuppressants or immunomodulators.\n\n• For subjects with relapsed\u002Frefractory Systemic Systemic Sclerosis: Diagnosed with systemic sclerosis (SSc) according to the 2013 EULAR\u002FACR classification criteria for SSc.\n\nClassified as diffuse cutaneous or limited cutaneous subtype with a disease duration ≤7 years (from the first occurrence of Raynaud's phenomenon to screening).\n\nIf interstitial lung disease (ILD) is present at screening, forced vital capacity (FVC) must be ≥45% of predicted value, or diffusing capacity for carbon monoxide (DLCO) must be ≥40% of predicted value.\n\nRelapsed\u002Frefractory is defined as: failure to respond to prior conventional therapy or disease relapse after remission. Conventional therapy refers to the use of glucocorticoids combined with at least one immunosuppressive\u002Fimmunomodulatory drug for ≥6 months.\n\n• For subjects with refractory Idiopathic Inflammatory Myopathies: Diagnosed with idiopathic inflammatory myopathy (IIM) with a probability ≥55% according to the 2017 EULAR\u002FACR classification criteria for IIM, and classified as dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or anti-synthetase syndrome (ASyS) based on age at onset, cutaneous and muscle manifestations, laboratory findings, and muscle biopsy characteristics.\n\nDisease activity\u002Fseverity meets the following criteria: ①Manual Muscle Testing-8 (MMT-8) score ≤141 (total score 150). ②Meets at least two of the following additional abnormal CSMs: Patient Global Assessment of disease activity \\[based on Visual Analog Scale (VAS)\\] score ≥2 (range 0-10); Physician Global Assessment of disease activity VAS score ≥2 (range 0-10); Physician Global Assessment of extra-muscular disease activity VAS score ≥2 (range 0-10); HealthAssessment Questionnaire Disability Index (HAQ-DI) score ≥0.25 (range 0-3); At least one muscle enzyme level \\>1.5 times the upper limit of normal (ULN).\n\nPrevious intolerance or inadequate response to glucocorticoids and at least one immunosuppressant or immunomodulator for the aforementioned autoimmune disease, requiring: Treatment with glucocorticoids and at least one immunosuppressant at known effective doses for at least 3 months.\n\n• For subjects with relapsed\u002Frefractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Clinically diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definitions established at the 2012 Chapel Hill Consensus Conference (CHCC).\n\nMeet at least one major item or at least three other items in the Birmingham Vasculitis Activity Score (BVAS) version 3.\n\nTest positive for anti-proteinase 3 (PR3-ANCA) antibody or anti-myeloperoxidase (MPO-ANCA) antibody at screening.\n\nRelapsed\u002Frefractory is defined as: Relapsed AAV subjects: Disease relapse (defined as: presence of at least one major item or at least three other items in BVAS assessment, or occurrence of 1-2 new other items in two consecutive assessments) after achieving initial efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) following at least 3 months of treatment with glucocorticoids combined with immunosuppressants, with relapse occurring within 12 weeks prior to screening; Refractory AAV subjects: Failure to achieve efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) after at least 3 months of treatment with glucocorticoids combined with immunosuppressants.\n\n• For subjects with active Sjögren's Syndrome: Diagnosed with Sjögren's syndrome (SS) according to the 2016 EULAR\u002FACR classification criteria.\n\nUnstimulated whole salivary flow rate ≥0.05 mL\u002Fmin or stimulated whole salivary flow rate ≥0.01 mL\u002Fmin at screening.\n\nActive disease defined as: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5 points.\n\n• For subjects with refractory Antiphospholipid Syndrome: Diagnosed with antiphospholipid syndrome (APS) according to the 2006 Sydney Revised Classification Criteria for APS or the 2023 ACR\u002FEULAR Classification Criteria for APS; Positive for antiphospholipid antibodies (including lupus anticoagulant, anticardiolipin antibodies, and anti-β2 glycoprotein I antibodies) on at least two occasions \\>12 weeks apart; Presence of at least one non-criteria clinical manifestation, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valvular heart disease, and neurological manifestations.\n\n• For subjects with chronic\u002Frefractory Immune Thrombocytopenia: Diagnosed with immune thrombocytopenia (ITP) according to the Chinese Guideline for Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition).\n\nPatients who previously received at least one guideline-recommended standard ITP treatment but exhibited inability to maintain response, relapse, intolerance to standard therapy, or insufficient response.\n\nChronic\u002Frefractory definition: Chronic: Persistent thrombocytopenia for ≥12 months; Refractory: Failure to respond to first-line therapies, thrombopoietin receptor agonists, and rituximab; or failure\u002Frelapse after splenectomy; with confirmed ITP diagnosis upon recent reassessment.\n\nExclusion Criteria:\n\n* Patients with a history or concurrent diagnosis of active malignancies, including tumor-associated polymyositis\u002Fdermatomyositis, are excluded. Exceptions include cured or non-recurrent cervical carcinoma in situ for at least 3 years, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, or ductal carcinoma in situ after radical surgery.\n* Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products.\n* Patients with severe pulmonary diseases within the past year, such as moderate to severe pulmonary hypertension (pulmonary artery systolic pressure \\> 50 mmHg on echocardiography), or those requiring oxygen therapy via a reservoir mask or non-invasive\u002Finvasive mechanical ventilation during screening.\n* Patients who have received any of the following medications or treatments within the specified timeframes:\n\nB-cell-depleting therapy within 6 months before screening, assessed by the investigator as not having failed treatment, including anti-CD20, anti-CD22, anti-CD52, anti-CD38 or ant-BCMA monoclonal antibodies or bispecific antibodies.\n\nHigh-dose intravenous immunoglobulin (IVIG) within 3 months before screening. Dialysis or plasmapheresis within 2 months before screening. Glucocorticoid pulse therapy (defined as ≥ 200 mg\u002Fday prednisone or equivalent doses of other glucocorticoids) within 2 months before screening.\n\nUsed telitacicept within 6 weeks before screening, or belimumab within 8 weeks before screening.\n\nThrombopoietin (TPO) or TPO receptor agonists (TPO-RA) or any other medication with a clearly indicated platelet-boosting effect, ortransfusion therapy (including platelet transfusion) within 2 weeks before screening (ITP subjects are without restrictions).\n\n* Patients with a history of severe central nervous system (CNS) disorders history or related symptoms (excluding isolated trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular diseases, encephalitis, brain injury, aneurysm, cerebellar disorders, organic brain syndrome, Parkinson's disease as well as symptoms such as epilepsy, convulsion, aphasia, dementia.\n* Complicated with severe renal disease, defined as any of the following within 8 weeks before screening:\n\nSevere lupus nephritis \\[defined as urine protein \\> 6g\u002F24h or serum creatinine \\> 1.5×ULN.\n\nCreatinine clearance (Cockcroft Gault formula) \\\u003C 40mL\u002Fmin\\]. Active nephritis requiring treatment that are prohibited per protocol. Requiring hemodialysis or plasmapheresis, or receiving prednisone \\> 100mg\u002Fd or equivalent corticosteroid therapy ≥14 days.\n\n* Patients with severe allergies to any components of the lymphodepletion regimen or CD19 UCAR-T therapy used in this study.\n* Patients who meet any of the following criteria:\n\nPositive for hepatitis B surface antigen (HBsAg) AND positive for hepatitis B core antibody (HBcAb) with detectable HBV DNA in peripheral blood.\n\nPositive for hepatitis C virus (HCV) antibody with detectable HCV RNA. Positive for Treponema pallidum antibody. Positive for HIV antibody.\n\n* Patients with uncontrolled fungal, bacterial, or viral infections, or any other active infections are assessed as inappropriate to participate in the study by investigator .\n* Patients with a history of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Patients with active tuberculosis (TB) or latent TB infection (defined as positive tuberculin skin test or interferon-gamma release assay results without clinical symptoms or radiographic evidence) at screening;\n* Patients who have experienced any of the following cardiovascular events within 6 months before screening (including but not limited to):\n\nCongestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary\u002Fperipheral artery bypass grafting.\n\nSevere arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, etc.). Congenital long QT syndrome and left anterior fascicular block (bifascicular block). Asymptomatic right bundle branch block is permitted for enrollment.\n\nUncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n\n* Patients with a history of autoimmune diseases (other than the target indications) that need systemic treatments, including but not limited to: eosinophilic granulomatous with polyangiitis (EGPA), Henoch-Schönlein purpura (HSP), rheumatoid arthritis, cryoglobulinemia vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behcet's disease or Takayasu's arteritis, etc..\n* Patients with non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy, thyroid myopathy, or a family history of myopathy.\n* History of catastrophic APS within 3 months prior to screening;\n* Pregnant or lactating women.\n* Patients who have received live vaccines within 6 weeks prior to lymphodepleting chemotherapy.\n* Patients who meet any of the following criteria:\n\nParticipate in other interventional clinical studies, and receipt of any investigational treatment within 3 months before signing the informed consent form.\n\nIntent to participate in another clinical trial during the entire study period. Plan to receive non-protocol-specified treatments for autoimmune diseases.\n\n* Patients with psychiatric disorders including depression or suicidal tendency.\n* Patients deemed by the investigator to have other factors that may make them unsuitable for participation or may affect their ability to complete the study.",{"count":373,"type":22},24,[127],"The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.",[56,377,378,379,380,28,381],"Idiopahic Inflammatory Myopathies","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Sjögren's Syndrome","Antiphospholipid Syndrome","Systemic Sclerosis",{"date":383,"type":33},"2025-12-19",{"date":385,"type":22},"2026-01-30",{"date":387,"type":22},"2027-07-20",{"name":261,"class":65},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":4},"100615909","the-value-of-interleukin-1-and-interleukin-33-genetic-expression-in-the-pathogenesis-and-differentiation-of-primary-itp-and-sle-related-thrombocytopenia-100615909","NCT07298733","The Value of Interleukin-1β and Interleukin-33 Genetic Expression in the Pathogenesis and Differentiation of Primary ITP and SLE-Related Thrombocytopenia","Inclusion Criteria:\n\n* • Adults (18-60 years).\n\n  * Diagnosed primary ITP\n  * Diagnosed SLE with thrombocytopenia\n\nExclusion Criteria:\n\n* • Patients on recent immunosuppressive therapy (\\\u003C4 weeks).\n\n  * Co-existing infections, malignancies, or other autoimmune cytopenias","60 Years",{"count":397,"type":22},300,"Primary immune thrombocytopenia (ITP) is an autoimmune- mediated acquired bleeding disorder, defined as a platelet count less than 100×109\u002FL without other causes of isolated thrombocytopenia. The etiology of ITP is complex and heterogeneous, and as no specific biomarkers are indicating its presence, ITP remains a diagnosis of exclusion. The heterogeneous nature of ITP is evident in the differences in clinical presentation and response to regular treatment among patients and the multiple mechanisms that have been forwarded to account for it, such as autoantibodies, T cell dysregulation, and impaired megakaryocytes. Except primary ITP, all forms of immune-mediated thrombocytopenia is defined as secondary ITP. Secondary ITP has several causes, including autoimmune diseases such as systemic lupus erythematosus",[28,400],"System; Lupus Erythematosus",[402,354,403,404],"gene expression","inflammation","autoimmune","2025-12-09",{"date":332,"type":33},{"date":408,"type":22},"2026-01-01",{"date":410,"type":22},"2026-12-31",{"name":412,"class":65},"Sohag University",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100556013","early-phase-1-safety-and-efficacy-of-prg-1801-in-recurrentrefractory-primary-immune-thrombocytopenia-itp-100556013","NCT06519565","Safety and Efficacy of PRG-1801 in Recurrent\u002FRefractory Primary Immune Thrombocytopenia (ITP)","Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of Recurrent\u002FRefractory Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* 1\\. Age ≥18 years, regardless of gender.\n* 2\\. Clinically diagnosed with primary immune thrombocytopenia for at least 6 months, with a platelet count \\\u003C30×10\\^9\u002FL within 48 hours before participating in the study.\n* 3\\. Positive for anti-platelet glycoprotein autoantibodies (such as GPIIb\u002FIIIa).\n* 4\\. Previously received first-line and\u002For second-line ITP treatment (first-line treatment includes: corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as eltrombopag, romiplostim) and\u002For rituximab, etc.), but the treatment was ineffective (platelet count \\\u003C30×10\\^9\u002FL after treatment, or platelet count did not increase to twice the baseline value, or there was bleeding), or relapsed after effective treatment (platelet count dropped below 30×10\\^9\u002FL after effective treatment, or dropped to less than twice the baseline value, or bleeding symptoms occurred) or difficult to maintain after stopping TPO receptor agonists.\n* 5\\. Basic normal function of important organs:\n\n  * Echocardiography indicates an ejection fraction ≥50%, and the electrocardiogram shows no significant abnormalities.\n  * Creatinine clearance rate (CrCl) (Cockcroft-Gault formula) ≥30 mL\u002Fmin.\n  * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3.0× the upper limit of normal (ULN).\n  * Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0×ULN (Gilbert's syndrome ≤ 3.0×ULN).\n  * Absolute lymphocyte count (ALC) ≥0.5×10\\^9\u002FL; absolute neutrophil count (ANC) ≥1×10\\^9\u002FL; hemoglobin (Hb) ≥60 g\u002FL; platelet count ≥10×10\\^9\u002FL.\n  * Blood oxygen saturation \\>92%.\n* 6\\. Meet the standards for apheresis or venous blood collection, and have no contraindications to cell collection.\n* 7\\. Men of reproductive potential and women of childbearing age must agree to use effective contraception from the signing of the informed consent form until 1 year after the use of the study drug. Blood pregnancy tests for women of childbearing age must be negative at screening and before cell infusion, and they must not be breastfeeding.\n* 8\\. The participant or their guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating their understanding of the purpose and procedures of this clinical trial and their willingness to participate in the study.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.\n* 2\\. Bone marrow examination during the screening period suggests myelofibrosis MF≥2 (European consensus scoring standard Thieleja2005) or bone marrow examination indicates the presence of primary diseases other than ITP that can cause thrombocytopenia.\n* 3\\. Allergic history to any component in the cell product.\n* 4\\. Suffering from any of the following heart diseases:\n\n  * Congestive heart failure of NYHA class III or IV.\n  * Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months before signing the ICF.\n  * Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding vasovagal syncope or dehydration).\n  * Severe non-ischemic cardiomyopathy history.\n* 5\\. Malignant tumors within the past 3 years before screening, except for the following: malignant tumors that have been treated radically and have no known active disease for ≥3 years before enrollment; or well-treated non-melanoma skin cancer with no evidence of disease.\n* 6\\. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requiring anticoagulant therapy.\n* 7\\. Participation in other interventional clinical studies within 1 month before screening.\n* 8\\. Vaccination with attenuated live vaccines within 4 weeks before screening.\n* 9\\. Stroke or epileptic seizure within 6 months before signing the ICF (excluding old lacunar cerebral infarction).\n* 10\\. The following treatments before CAR-T reinfusion: immunosuppressive treatment within 3 days; use of prednisone (or equivalent drugs) at a dose \\>10mg\u002Fday within 3 days.\n* 11\\. The following treatments before CAR-T reinfusion: treatment with B-cell depleting agents such as rituximab within 24 weeks (unless B cells have recovered); immunoglobulin reinfusion treatment within 4 weeks.\n* 12\\. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection exceeds the normal range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA titer detection exceeds the normal range; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* 13\\. Other conditions deemed unsuitable for participation in the study by the researcher.",{"count":199,"type":22},[422],"EARLY_PHASE1","This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed\u002Frefractory immune thrombocytopenia (ITP).",[28],"2025-11-23",{"date":427,"type":33},"2025-11-28",{"date":429,"type":33},"2024-08-20",{"date":431,"type":22},"2027-08-15",{"name":433,"class":65},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",2,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":66},"100529059","phase-2-anti-cd38-antibody-treating-pediatric-primary-immune-thrombocytopenia-itp-100529059","NCT06168851","Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Pediatric Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 6 years and above, male or female\n* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)\n* Diagnosis of ITP ≥3 months, and with a platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to inclusion\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs.\n* The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration\n* Signed and dated written informed consent\n* With normal hepatic and renal functions\n* ECOG physical state score ≤ 2 points\n* Cardiac function of the New York Society of Cardiac Function ≤ 2\n* Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg\u002Fkg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\\>3 months；More than 6 months after splenectomy.\n\nMarch 26,2024 After approval by the Ethics Committee，age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2.\n\nExclusion Criteria:\n\n* Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting \\\u003C6 months；\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Patients taking antiplatelet drugs at the same time;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.","17 Years",{"count":21,"type":22},[53],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and\u002For TPO-RA, or those in whom no other second-line treatment options are suitable.",[28,252],"2025-11-21",{"date":427,"type":33},{"date":450,"type":33},"2023-12-28",{"date":452,"type":22},"2030-12",{"name":261,"class":65},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":19,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":66},"100580566","phase-2-anti-cd38-antibody-treating-children-with-primary-immune-thrombocytopenia-itp-100580566","NCT06838962","Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Children With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age ≥6 years, ≤18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and\u002For intravenous human immunoglobulin) (PLT≥50×10\\^9\u002FL);\n* Platelet count \\\u003C30×10\\^9\u002FL within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count \\\u003C30×10\\^9\u002FL and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of enrollment, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the first dose of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4\u002F6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.\n* All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.\n* Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.\n* Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.\n* Patients taking antiplatelet drugs within 3 weeks before the first dose.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive anti-CD20 monoclonal antibodies such as rituximab, or medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL; IgG \\\u003C 500 mg\u002FdL.\n  5. lymphocyte count \\\u003C 500\u002Fmm3.\n  6. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":462,"type":22},30,[53],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.",[28,252],"2025-07-31",{"date":468,"type":33},"2025-08-05",{"date":470,"type":33},"2024-08-01",{"date":472,"type":22},"2026-08",{"name":261,"class":65},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":66},"100575763","phase-1-a-clinical-study-of-nad-in-the-treatment-of-immune-thrombocytopenia-100575763","NCT06776510","A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Nicotinamide Adenine Dinucleotide in the Treatment of Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female;\n* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP) ≥3 months;\n* Failure to achieve response or relapse after corticosteroid therapy, and failure to achieve response or relapse after previous second-line treatments such as TPO\u002FTPORAs therapy, or are unable to afford the cost of the treatment;\n* The platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to inclusion (During the screening visit and\u002For before receiving the study drug, platelet counts must be less than 30×10\\^9\u002FL on at least two consecutive occasions, with a minimum interval of 1 day between the two tests.);\n* ECOG physical state score ≤ 2 points;\n* Subjects on stable dose maintenance therapy are allowed to be included (concomitant medications may include corticosteroids (≤0.5 mg\u002Fkg of prednisone or equivalent steroids) or TPO receptor agonists, etc.), but at the time of enrollment, only one concomitant medication with a stable dose is permitted. The concomitant medication must have been on a stable dose for at least 4 weeks prior to the first dose of the study drug;\n* For female patients of childbearing potential, a negative pregnancy test result is required. Both female patients of childbearing potential and male patients must use highly effective contraception during the study and for 4 months\u002F6 months after discontinuing treatment;\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Those who are allergic to Nicotinamide adenine dinucleotide or excipients, or who have previously received CD38 monoclonal antibody treatment with no efficacy.\n* Those with autoimmune hemolytic anemia, or various types of secondary and genetic thrombocytopenia, such as leukemia, lymphoma, multiple myeloma, aplastic anemia, myelodysplastic syndrome, Evans syndrome, common variable immunodeficiency, systemic lupus erythematosus, cirrhosis, antiphospholipid antibody syndrome, pseudo-thrombocytopenia, drug-induced thrombocytopenia (e.g., quinine, heparin, antimicrobial drugs, anticonvulsants, etc.).\n* A history of any thrombosis or embolism events within 12 months prior to the first dose, or the presence of extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, sepsis, or other irregular bleeding.\n* Participation in any other clinical trial involving investigational drugs (including vaccine studies) or exposure to other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.\n* Use of anticoagulants or any drugs with antiplatelet effects (e.g., aspirin) within 2 weeks prior to the first dose.\n* Receiving emergency treatment for ITP within 2 weeks prior to the first dose (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin, or TPO receptor agonist treatment).\n* Receiving azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, or similar drugs within 4 weeks prior to the first dose; receiving CD20 monoclonal antibodies such as rituximab, cyclophosphamide, vincristine, or similar drugs within 3 months prior to the first dose.\n* Splenectomy within 6 months prior to the first dose.\n* Receiving a live vaccine within 4 weeks prior to the first dose, or planning to receive any live vaccine during the study period.\n* A history of undergoing allogeneic stem cell transplantation or organ transplantation.\n* A history of clinically significant diseases that, in the investigator's opinion, may pose a risk to the subject's safety or affect the assessment of safety or efficacy during the study if the disease\u002Fcondition worsens.\n* Subjects who have had malignant tumors within the past 5 years prior to screening (excluding completely cured carcinoma in situ of the cervix and non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin).\n* Exhibiting clinically significant laboratory abnormalities at screening: a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ the upper limit of normal (ULN); b) Total bilirubin ≥ 1.2 times ULN. ;c) Creatinine or blood urea nitrogen (BUN) ≥ ULN.\n* Positive for HIV antibodies or syphilis antibodies.\n* Positive for hepatitis B surface antigen (HBsAg) at screening, or positive for hepatitis B core antibody with a positive HBV-DNA result by polymerase chain reaction (PCR) testing, or positive for hepatitis C virus (HCV) antibodies.\n* Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study; and men whose partners are planning to become pregnant during the study.\n* Subjects with mental disorders who are unable to provide informed consent or participate in the trial and follow-up properly.\n* Subjects with unresolved toxicity symptoms caused by prior treatments before participating in the trial.\n* Any other conditions deemed unsuitable for participation in this study as assessed by the investigator.",{"count":287,"type":22},[156,53],"To evaluate the safety and efficacy of nicotinamide adenine dinucleotide in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and\u002For TPO-RA.",[28,252],{"date":468,"type":33},{"date":487,"type":33},"2025-01-15",{"date":489,"type":22},"2026-03-01",{"name":261,"class":65},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":501,"studyType":77,"phases":4,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100450956","itp-registry-and-accompanying-biospecimen-collection-100450956","NCT05152238","ITP Registry and Accompanying Biospecimen Collection","Multicenter National ITP Registry and Accompanying Biospecimen Collection","ITP-Registry","Inclusion Criteria:\n\n* Primary or secondary Immune Thrombocytopenia (ITP)\n* Age ≥18 years\n* signed declaration of consent\n\nExclusion Criteria:\n\n* diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)\n* no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)",{"count":500,"type":22},1100,"5 Years","The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.",[28],"2025-07-10",{"date":506,"type":33},"2025-07-15",{"date":508,"type":33},"2021-11-29",{"date":510,"type":22},"2027-04",{"name":512,"class":65},"Jena University Hospital",64,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":348,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":66},"100597930","phase-2-the-combination-of-upadacitinib-and-high-dose-dexamethasone-as-first-line-treatment-in-adult-immune-thrombocytopenia-100597930","NCT07064889","The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia","The Combination of Oral Upadacitinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial","Inclusion Criteria:\n\n1. Confirmed newly-diagnosed, treatment-naive ITP;\n2. Platelet counts \\\u003C30×109\u002FL ;\n3. Platelet counts \\\u003C 50×109\u002FL and significant bleeding symptoms (WHO bleeding scale 2 or above);\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;\n2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;\n3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;\n4. Active infection;\n5. Maligancy;\n6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);\n7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy\n8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;\n9. Patients who are deemed unsuitable for the study by the investigator.",{"count":522,"type":22},132,[53],"Randomized, open-label, multicenter study to compare the efficacy and safety of Upadacitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).",[28],"2025-07-07",{"date":506,"type":33},{"date":529,"type":22},"2025-07-30",{"date":531,"type":22},"2027-12-30",{"name":239,"class":65},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":18,"minAge":395,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":550,"locationsCount":66},"100597800","phase-2-anti-cd38-antibody-treating-elderly-patients-with-primary-immune-thrombocytopenia-itp-100597800","NCT07063199","Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)","A Single-arm, Open-label Clinical Study Evaluating the Safety and Efficacy of Daratumumab in Elderly Patients With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age ≥60 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy and at least one standard second-line therapy. (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and\u002For intravenous human immunoglobulin) (PLT≥50×10\\^9\u002FL);\n* Platelet count \\\u003C30×10\\^9\u002FL within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count \\\u003C30×10\\^9\u002FL and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of enrollment, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the first dose of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4\u002F6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.\n* All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.\n* Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.\n* Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.\n* Subjects taking antiplatelet drugs within 3 weeks before the first dose.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive anti-CD20 monoclonal antibodies such as rituximab, or medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n\nSubjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL; IgG \\\u003C 500 mg\u002FdL.\n  5. lymphocyte count \\\u003C 500\u002Fmm3.\n  6. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":462,"type":22},[53],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.",[28,252],"2025-07-03",{"date":546,"type":33},"2025-07-14",{"date":548,"type":22},"2025-08",{"date":472,"type":22},{"name":261,"class":65},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":66},"100362933","biological-bank-for-the-patients-followed-in-a-constitutive-reference-center-for-autoimmune-cytopenia-100362933","NCT04005638","Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia","BIOCAI","Inclusion Criteria:\n\n* Patients over 16 years old.\n* Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).\n* Affiliated person or beneficiary of a social security scheme.\n* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Positivity for HIV, Hepatitis C or B virus.\n* Pregnant or lactating woman.\n* Patient undergoing treatment for autoimmune cytopenia",{"count":559,"type":22},200,"The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units (\"Bedside to the Bench Strategy\"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.",[28,329,562],"Autoimmune Neutropenia",[564],"Biological collection","2025-03-25",{"date":567,"type":33},"2025-03-26",{"date":569,"type":33},"2019-02-02",{"date":571,"type":22},"2027-01",{"name":145,"class":65}]