[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Candid Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,92,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637088","phase-1-a-clinical-study-of-cizutamig-in-thyroid-eye-disease-100637088",false,"NCT07597200","A Clinical Study of Cizutamig in Thyroid Eye Disease","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Thyroid Eye Disease","Inclusion Criteria:\n\n* 18-75 years old at the time of signing the Informed Consent Form\n* Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at Screening and Day 1\n\nExclusion Criteria:\n\n* Inadequate clinical laboratory parameters at Screening\n* Active infection present\n* Receipt of, or inability to discontinue, any of the excluded therapies\n* History of progressive multifocal leukoencephalopathy\n* History of primary immunodeficiency\n* Central nervous system disorders that the investigator considers would increase risk to the subject\n* Investigator-determined significant comorbidity(ies)\n* Have a diagnosis or history of malignant disease within 5 years prior to Screening\n* Active tuberculosis or lack of documentation of completed treatment for active pulmonary tuberculosis\n* History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig\n* Pregnant or breastfeeding women\n* Patients who do not agree to use highly effective contraception as specified in the protocol","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).",[27],"Thyroid Eye Disease, TED","RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":32},"2026-05-08",{"date":36,"type":21},"2028-06-30",{"name":38,"class":39},"Candid Therapeutics","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":40},"100624379","phase-1-a-phase-1-study-of-cizutamig-in-ige-mediated-diseases-100624379","NCT07408869","A Phase 1 Study of Cizutamig in IgE Mediated Diseases","A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases","Inclusion Criteria:\n\n1. Patient meets at least one of the following:\n\n   1. History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg\u002Fegg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and\u002For shrimp) with Screening total IgE ≥ 400 IU\u002FmL\n   2. Diagnosis of chronic rhinosinusitis with Screening total IgE \\> ULN\n   3. Diagnosis of allergic rhinitis with Screening total IgE \\> ULN\n   4. Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE \\> ULN\n   5. Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE \\> ULN\n   6. Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE \\> ULN\n2. Agree to the use of highly effective contraception\n\nExclusion Criteria:\n\n1. Elevated IgE levels for reasons other than the IgE mediated diseases\n2. Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)\n3. Current use of any allergen immunotherapy.\n4. Individuals whose allergen exposures in their home and\u002For work environments may be expected to change significantly during the trial period\n5. Inadequate clinical laboratory parameters at Screening\n6. Receipt of or inability to discontinue any excluded therapies\n7. Individuals who will decline blood products\n8. Active infection\n9. Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF\n10. Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)\n11. History of primary immunodeficiency\n12. History of CNS disease\n13. History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years\n14. History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug\n15. Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period\n16. Blood donation or significant blood loss within 30 days prior to screening\n17. Individuals considered to be part of a vulnerable population (eg, incarceration)\n18. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n19. Inability to comply with protocol-mandated requirements\n20. A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease","65 Years",{"count":50,"type":21},20,[24],"The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.",[54,55,56],"IgE-Mediated Hypersensitivity","IgE Mediated Food Allergy","IgE-Mediated Cow Milk Allergy",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"peanut allergy","nut allergy","hazelnut allergy","walnut allergy","cashew allergy","milk allergy","egg allergy","soy allergy","wheat allergy","sesame allergy","cod allergy","salmon allergy","tuna allergy","lobster allergy","crab allergy","shrimp allergy","food allergy","rhinosinusitis","allergic rhinitis","asthma","urticaria","atopic dermatitis","immune system","cizutamig","T cell engager","NOT_YET_RECRUITING","2026-04-14",{"date":86,"type":32},"2026-04-16",{"date":88,"type":21},"2026-04",{"date":90,"type":21},"2026-12",{"name":38,"class":39},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":40},"100609521","phase-1-clinical-study-of-cizutamig-in-systemic-lupus-erythematosus-100609521","NCT07215663","Clinical Study of Cizutamig in Systemic Lupus Erythematosus","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. 18 to 75 years old at the time of signing the informed consent form\n2. Diagnosis of SLE according to the ACR\u002FEULAR classification criteria\n3. Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening\n4. SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening\n5. The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening\n6. Stable use of concomitant therapies\n7. For patients with active LN only: LN Class III or IV\n\nExclusion Criteria:\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. Receipt of live vaccine within 4 weeks prior to Screening\n5. Presence of any concomitant autoimmune disease\n6. Active or known history of catastrophic anti-phospholipid syndrome (APS)\n7. APS or thrombotic event not adequately controlled by anticoagulation therapy\n8. History of progressive multifocal leukoencephalopathy\n9. History of primary immunodeficiency or a hereditary deficiency of the complement system\n10. Central nervous system disease\n11. Presence of 1 or more significant concurrent medical conditions\n12. Have a diagnosis or history of malignant disease within 5 years\n13. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice\n14. Inability to comply with protocol-mandated requirements\n15. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig\n16. History of or planned organ transplant and\u002For autologous or allogeneic hematopoietic stem cell transplantation\n17. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study\n18. Women who are pregnant or breastfeeding\n19. Patients who do not agree to the use of highly effective contraception as defined by the protocol\n20. Individuals considered to be part of a vulnerable population (eg, incarceration)",{"count":100,"type":21},47,[24],"The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus",[104],"Systemic Lupus Erythematosus (SLE)","2025-11-13",{"date":107,"type":32},"2025-11-17",{"date":109,"type":32},"2025-09-04",{"date":111,"type":21},"2028-04",{"name":38,"class":39},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":130,"locationsCount":40},"100609520","phase-1-clinical-study-of-cizutamig-in-generalized-myasthenia-gravis-gmg-100609520","NCT07215650","Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Generalized Myasthenia Gravis (gMG)","Inclusion Criteria:\n\n1. At least 18 years old at the time of signing the Informed Consent Form (ICF);\n2. Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigator as unlikely to require respiratory support during the study;\n3. At screening, the Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5, with non-ocular items accounting for ≥ 50% of the total score, and GMG ≥ 11;\n4. Inadequate response to conventional therapies or lack of effective treatment options, defined as disease recurrence or progression despite treatment with corticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate), or biologics (e.g., rituximab), and\u002For lack of effective treatment methods.\n\nExclusion Criteria:\n\n1. Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy;\n2. Use of any approved immunosuppressive drugs not listed here within 12 weeks or 5 half-lives (whichever is longer) before screening, unless approved by the medical monitor;\n3. Participation in any investigational trial involving non-biological agents within 4 weeks or 5 half-lives (whichever is longer) of the investigational product (IP) before screening;\n4. Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening;\n5. Administration of live vaccines within 4 weeks before screening;\n6. History of progressive multifocal leukoencephalopathy;\n7. History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency;\n8. Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to:\n\n   1. Poorly controlled diabetes\n   2. Chronic kidney disease stages IIIb, IV, or V\n   3. Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure\n9. Any severe medical condition or clinically significant laboratory abnormality that, in the judgment of the investigator or medical monitor, would compromise the patient's safe participation and completion of the study or may affect protocol compliance or interpretation of study results.",{"count":121,"type":21},44,[24],"The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Generalized Myasthenia Gravis.",[125],"Generalized Myasthenia Gravis",{"date":107,"type":32},{"date":128,"type":32},"2025-09-16",{"date":111,"type":21},{"name":38,"class":39},""]