[{"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:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,66,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100647808","phase-1-a-phase-1-first-in-human-study-of-cnd319-in-healthy-participants-and-patients-with-rheumatic-diseases-100647808",false,"NCT07712939","A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases","A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases","Inclusion Criteria (SAD):\n\n1. 18 to 65 years old\n2. Body mass index 18-30 kg\u002Fm2 and weight 55-100 kg\n3. Individuals in good health\n4. Agree to abstain from consumption of alcohol 48 hours prior to study visits\n5. Agree to the use of highly effective contraception as defined in the protocol\n\nInclusion Criteria (MAD and Part 2 Expansion):\n\nPatients with RA:\n\n1. 18 to 75 years old\n2. Diagnosis of adult-onset RA\n3. Class I-III RA\n4. Moderately to severely active RA\n\nPatients with SjD:\n\n1. 18 to 75 years old\n2. Diagnosis of primary SjD\n\nExclusion Criteria (SAD):\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons\n5. History of alcohol or drug abuse within last 12 months\n6. Positive alcohol breathalyzer or drug screen prior to dosing\n7. Inability to comply with protocol-mandated requirements\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug\n9. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study\n10. Blood donation or significant blood loss within 30 days\n11. Individuals considered to be part of a vulnerable population (eg, incarceration)\n12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n\nExclusion Criteria for patients with RA or SjD:\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. History of progressive multifocal leukoencephalopathy\n5. Central nervous system disease\n6. Presence of 1 or more significant concurrent medical conditions\n7. Have a diagnosis or history of malignant disease within 5 years\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug\n9. Women who are pregnant or breastfeeding\n10. Patients who do not agree to the use of highly effective contraception as defined by the protocol",true,"ALL","18 Years","65 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.",[28,29,30],"Healthy Participants Study","Rheumatoid Arthritis","Sjogren's Syndrome","RECRUITING","2026-07-21",{"date":34,"type":35},"2026-07-22","ACTUAL",{"date":37,"type":22},"2026-07-20",{"date":39,"type":22},"2028-03-31",{"name":41,"class":42},"Candid Therapeutics","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100637088","phase-1-a-clinical-study-of-cizutamig-in-thyroid-eye-disease-100637088","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","75 Years",{"count":53,"type":22},38,[25],"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).",[57],"Thyroid Eye Disease, TED","2026-05-13",{"date":60,"type":35},"2026-05-19",{"date":62,"type":35},"2026-05-08",{"date":64,"type":22},"2028-06-30",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},"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":74,"type":22},47,[25],"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",[78],"Systemic Lupus Erythematosus (SLE)","2025-11-13",{"date":81,"type":35},"2025-11-17",{"date":83,"type":35},"2025-09-04",{"date":85,"type":22},"2028-04",{"name":41,"class":42},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":43},"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":95,"type":22},44,[25],"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.",[99],"Generalized Myasthenia Gravis",{"date":81,"type":35},{"date":102,"type":35},"2025-09-16",{"date":85,"type":22},{"name":41,"class":42},""]