[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"warm-autoimmune-hemolytic-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:warm-autoimmune-hemolytic-anemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100635208","phase-1-safety-and-preliminary-efficacy-of-ctx112-in-adult-participants-with-relapsedrefractory-hematologic-autoimmune-disease-100635208",false,"NCT07549698","Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed\u002FRefractory Hematologic Autoimmune Disease","A Phase 1\u002F2 Dose Evaluation Trial of the Safety and Preliminary Efficacy of Anti CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Participants With Relapsed\u002FRefractory Hematologic Autoimmune Disease","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary function.\n4. Participants must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other trial procedures.\n6. Diagnosis of relapsed\u002Frefractory primary Immune Thrombocytopenic Purpura (ITP) or Warm Autoimmune Hemolytic Anemia (WAIHA)\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD19 therapy or any gene therapy or genetically modified cell therapy.\n2. Prior solid organ (e.g., heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. Presence of other active autoimmune disease or other conditions that are likely to pose increased safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n5. History of primary or secondary immunodeficiency.\n6. Presence or history of certain bacterial, viral or fungal infection\n7. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n8. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n9. History or current diagnosis that requires uninterrupted, ongoing anticoagulation.\n10. Pregnant or lactating.\n11. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a single-arm, open-label, multicenter, ascending dose Phase 1\u002F2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed\u002Frefractory primary Immune Thrombocytopenia (ITP) and relapsed\u002Frefractory primary Warm Autoimmune Hemolytic Anemia (wAIHA).",[27,28,29,30],"Warm Autoimmune Hemolytic Anemia (WAIHA)","ITP - Immune Thrombocytopenia","Warm Autoimmune Hemolytic Anemia","Immune Thrombocytopenic Purpura",[32,33,34,35,36,37,38,39,30,40],"CD19","CTX112","Zugocabtagene geleucel","zugo-cel","CAR-T","ITP","warm autoimmune hemolytic anemia","wAIHA","Immune Thrombocytopenia","RECRUITING","2026-06-11",{"date":44,"type":45},"2026-06-15","ACTUAL",{"date":47,"type":20},"2026-06",{"date":49,"type":20},"2033-12",{"name":51,"class":52},"CRISPR Therapeutics AG","INDUSTRY",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100595974","phase-2-study-of-ianalumab-in-adults-with-primary-immune-thrombocytopenia-itp-and-warm-antibody-autoimmune-hemolytic-anemia-waiha-who-have-previously-benefited-from-ianalumab-100595974","NCT07039422","Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab","A Phase 2 Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab.","VAY RE-HIT","Inclusion Criteria:\n\n* Signed informed consent obtained prior to participation in the study.\n* Male or female participants aged 18 years and older on the day of signing informed consent\n\nPrimary ITP patients:\n\n* Previously enrolled and treated either with ianalumab\u002Fplacebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with ianalumab\u002Fplacebo in addition to eltrombopag in the second line on protocol CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab\u002Fplacebo\n* Rescue medication and\u002For bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to the start of the therapy must be used to assess eligibility and have to be collected within 30 days prior to screening\n\nFor Primary or Secondary wAIHA patients:\n\n* Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with ianalumab\u002Fplacebo in blinded cohort or placebo followed by crossover to open label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab\u002Fplacebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm.\n* Relapsed wAIHA with hemoglobin concentration ≥5 g\u002FdL and \\\u003C10 g\u002FdL and presence of symptoms related to anemia during screening or within 14 days before screening window or within 28 days before screening window if rescue medication\u002Fbridging therapy has been initiated.\n* Rescue medication and\u002For bridging therapy are allowed to be started during the screening and within 28 days prior to screening; hemoglobin level result for eligibility assessment needs to be obtained prior to the start of the treatment within 30 days prior to screening\n* Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and has remained stable at least 4 weeks prior screening\n\nExclusion Criteria:\n\n* Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss or iron deficiency.\n* Secondary wAIHA with BM involvement for wAIHA patients\n* Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia\n* Therapy for ITP or wAIHA other than ianalumab\u002Fplacebo, bridging\u002Frescue therapies and supportive care prior to the beginning of the screening window\n* After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded.\n* ITP participants only: Participants with concurrent coagulation disorders and\u002For receiving anti-platelet or anti-coagulant medication except for low dose of acetylsalicylic acid (≤150 mg per day)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":19,"type":20},[24],"This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).",[66,29],"Primary Immune Thrombocytopenia",[68,37,69,39,70,71,72,73],"Primary Immune Thrombocytopenia (ITP)","Warm Autoimmune Hemolytic Anemia (wAIHA)","VAY736","Ianalumab","B-cell depletion","B-cell Activating Factor Receptor (BAFF-R) blockade","2026-06-04",{"date":76,"type":45},"2026-06-08",{"date":78,"type":20},"2026-06-26",{"date":80,"type":20},"2030-08-30",{"name":82,"class":52},"Novartis Pharmaceuticals",22,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100510329","sirolimus-in-the-treatment-of-refractoryrelapsed-waiha-100510329","NCT05925023","Sirolimus in the Treatment of Refractory\u002FRelapsed wAIHA","Sirolimus in the Treatment of Refractory\u002FRelapsed Warm Autoimmune Hemolytic Anemia (AIHA)： a Phase 2 Prospective Trial","Inclusion Criteria:\n\n1. Age ≥18 years old.\n2. Diagnosed as primary warm autoimmune hemolytic anemia or Evans syndrome (primary or secondary). There is no treatment indication of other systemic involvement in the original disease if secondary.\n3. No response to glucocorticoid therapy or recurrence.\n4. Baseline liver (ALT, AST) was less than 2 times the normal value.\n5. No active infection; Not pregnant or breastfeeding.\n6. Agree to sign the consent form.\n\nExclusion Criteria:\n\n1. Patients with connective tissue disease or other organs involvement\n2. Infection or bleeding that cannot be controlled by standard treatment.\n3. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.\n4. Progressed uncontrolled malignant tumors and lymphoma\n5. Cirrhosis or portal hypertension.\n6. Pregnant or breastfeeding.","90 Years",{"count":83,"type":20},[94],"NA","Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment. However, the recurrence rate is very high and some patients may not respond to steroids. Second-line therapies include cyclosporine A (CsA), cyclophosphamide, rituximab, azathioprine, and even splenectomy. Our previous study of sirolimus in refractory\u002Frelapsed AIHA and ES found an effective rate of 80%. Therefore, the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractory\u002Frelapsed wAIHA.",[29],[38,98,99,100,101],"Evans syndrome","refractory\u002Frelapsed","sirolimus","efficacy","2025-08-06",{"date":104,"type":45},"2025-08-08",{"date":106,"type":45},"2023-06-24",{"date":108,"type":20},"2025-12",{"name":110,"class":111},"Peking Union Medical College Hospital","OTHER",1]