[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sonoma Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100531562","phase-1-study-of-single-doses-of-sbt777101-in-subjects-with-rheumatoid-arthritis-100531562",false,"NCT06201416","Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis","Regulate-RA","Inclusion Criteria:\n\n* Body mass index (BMI) \\\u003C35 kg\u002Fm\\^2, inclusive\n* Adult-onset, moderate-to-severe rheumatoid arthritis (RA)\n* Moderate-to-severe active disease\n* b\u002FtsDMARD failure criterion (≥2)\n* Swollen joint count ≥4\n* Clinical and\u002For ultrasound evidence of synovitis\n* Prior inadequate response to or unable to tolerate available RA therapies\n* Stable doses of RA medications for at least 30 days\n* Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n* Recurrent infections or active infection\n* Active or untreated latent tuberculosis\n* Primary or secondary immunodeficiency\n* History of or current inflammatory joint disease other than RA","ALL","18 Years","70 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.",[28],"Rheumatoid Arthritis",[30,31,32,33,34,35,36,37,38],"rheumatoid arthritis","safety","regulatory T cells","CART","Treg","Inflammatory disease","autoimmune disease","autologous","cell therapy","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2024-03-06",{"date":47,"type":22},"2026-11",{"name":49,"class":50},"Sonoma Biotherapeutics, Inc.","INDUSTRY",9,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100602402","a-long-term-follow-up-observational-study-to-evaluate-safety-in-subjects-who-have-received-a-gene-modified-regulatory-t-cell-treg-therapeutic-100602402","NCT07123038","A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic","Inclusion Criteria:\n\n* Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.\n* Subject understands the purpose and risks of the study and is willing to provide written informed consent.\n* Subject is willing to comply with all study procedures for the follow-up period.\n\nExclusion Criteria:\n\n* Participation in the study is not in the subject's best interest, in the opinion of the Investigator","71 Years",{"count":60,"type":22},36,"OBSERVATIONAL","To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.",[64,65],"Rheumatoid Arthritis (RA)","Hidradenitis Suppurativa (HS)",[28,67,34,68,69,70,71,72],"Long Term Follow Up Study","SBT0000-01","Hidradenitis Suppurativa","SBT777101","SBT777101-01","SBT777101-02","2026-04-15",{"date":75,"type":43},"2026-04-16",{"date":77,"type":43},"2025-07-22",{"date":79,"type":22},"2040-12",{"name":49,"class":50},10,""]