[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610991":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":36,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":36,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":36,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Kali Therapeutics, Inc.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1","EXPERIMENTAL","KT501 Subcutaneous Injection Dose Level 1",[13],"Drug: KT501",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Level 2","KT501 Subcutaneous Injection Dose Level 2",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Level 3","KT501 Subcutaneous Injection Dose Level 3",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Level 4","KT501 Subcutaneous Injection Dose Level 4",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Dose Level 5","KT501 Subcutaneous Injection Dose Level 5",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","KT501","KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.",[9,15,19,23,27],null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Trial Information","CONTACT","1-858-888-3080","clinical@kalitherapeutics.com",[44],{"facility":45,"status":46,"city":47,"state":36,"zip":36,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":36},"Kali Study Site","RECRUITING","Bayswater","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],115.91776,-31.91686,{"lat":54,"lon":53},{"type":57,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100610991","phase-1-a-first-in-human-study-of-kt501-administered-subcutaneously-to-patients-with-rheumatoid-arthritis-ra-100610991",false,"NCT07234773","A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).","A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis","Inclusion Criteria:\n\n1. 18 to 75 years old\n2. Diagnosis of adult-onset RA for at least 6 months\n3. Moderately to severely active RA\n4. Inadequate treatment response as defined in the protocol\n5. RF + or ACPA+\n6. Stable use of traditional DMARDs is permitted\n7. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Functional class IV as defined by the ACR Classification of Functional Status in RA\n2. Presence of any concomitant autoimmune disease other than RA\n3. Active infection, history of serious recurrent or chronic infection\n4. History of progressive multifocal leukoencephalopathy\n5. Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.\n6. History of or planned organ transplant and\u002For autologous or allogeneic hematopoietic stem cell transplantation\n7. Receipt of live vaccine within 4 weeks\n8. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study\n9. Women who are pregnant or breastfeeding\n10. Significant or uncontrolled medical disease that would preclude participant participation","ALL","18 Years","75 Years",{"count":69,"type":70},24,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).",[76],"Rheumatoid Arthritis (RA)",[76,78,79,80],"Autoimmune","T-cell Engagers (TCEs)","B-cell Depletion","2026-03-06",{"date":83,"type":84},"2026-03-10","ACTUAL",{"date":81,"type":70},{"date":87,"type":70},"2027-08",{"name":5,"class":6},1]