[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568402":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":85,"collaborators":22,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":22,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":22,"enrollmentInfo":96,"targetDuration":22,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":22,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"ARCE Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"phase 1 (Dose Escalation) and phase 2 (Dose Expansion)","EXPERIMENTAL","In Phase 1, three escalating dose levels will be tested using the 3 + 3 design. The MTD and RP2D will be identified.\n\nThe Phase 2 will be conducted in 2 stages. In Stage I, evaluable participants from Phase 1 treated at RP2D will be enrolled. And the enrollment will continue into Stage II (additional evaluable participants) at the maximum RP2D participants for preliminary overall assessment of efficacy and safety.",[13,14,15],"Biological: ARD103","Drug: Cyclophosphamide","Drug: Fludarabine",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","ARD103","ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Cyclophosphamide","iv administration for lymphodepletion",[9],{"type":24,"name":29,"description":26,"armGroupLabels":30,"otherNames":22},"Fludarabine",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"ARCE Therapeutics, Inc","CONTACT","+886-2-26581868","contact@arcetherapeutics.com",[38,57,70],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Novant Health Cancer Institute","RECRUITING","Charlotte","North Carolina","28204","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.84313,35.22709,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":22,"email":56},"Kunal Shah","980-302-6297","kashah@novanthealth.org",{"facility":39,"status":40,"city":58,"state":42,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Winston-Salem","27201",{"type":47,"coordinates":61},[62,63],-80.24422,36.09986,{"lat":63,"lon":62},[66],{"name":67,"role":34,"phone":68,"phoneExt":22,"email":69},"Gait Jordan","336-718-8553","PJordan@novanthealth.org",{"facility":71,"status":40,"city":72,"state":73,"zip":74,"country":44,"countryCode":45,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":47,"coordinates":76},[77,78],-95.36327,29.76328,{"lat":78,"lon":77},[81],{"name":82,"role":34,"phone":83,"phoneExt":22,"email":84},"Dr. Abhishek Maiti","713.745.3228","AMaiti@mdanderson.org",{"type":86,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100568402","phase-1-clinical-study-of-ard103-car-t-therapy-for-patients-with-rr-aml-or-mds-100568402",false,"NCT06680752","Clinical Study of ARD103 CAR-T Therapy for Patients With R\u002FR AML or MDS","A Phase 1\u002F2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic status:\n\n  * Absolute lymphocyte count (ALC) \\> 100\u002Fmm3\n* Adequate renal, hepatic, cardiac and pulmonary function:\n\n  * ALT and AST \\\u003C 3.0 × the ULN\n  * Creatinine clearance ≥ 45.0 mL\u002Fmin as estimated by Cockcroft-Gault and independent dialysis\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test\n* Contraception: males and females of childbearing potential must agree to use an effective method of contraception\n* Participant is capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Presence of active and clinically relevant central nervous system (CNS) disorder\n* Autoimmune disease requiring immunosuppressive treatment\n* Participants with known hepatic bridging cirrhosis\n* Currently active infection with hepatitis B or C\n* Previous treatment with investigational gene or cell therapy (including CAR therapy)\n* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)\n* Previous chemotherapy including biologic\u002Ftargeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration","ALL","18 Years",{"count":97,"type":98},49,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","This is a phase I\u002F2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.",[105,106,107],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory","MDS (Myelodysplastic Syndrome)","2025-12-04",{"date":110,"type":111},"2025-12-10","ACTUAL",{"date":113,"type":111},"2025-05-20",{"date":115,"type":98},"2028-12",{"name":5,"class":6},3]