[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651093":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic plasma exchange (TPE)",null,"Patients with severe immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICIs) who will received therapeutic plasma exchange (TPE; performed using FDA-cleared apheresis devices (Spectra Optia Apheresis System)) as part of their standard-of-care.",[13],"Device: Spectra Optia Apheresis System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Spectra Optia Apheresis System","Therapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care.",[9],[21],{"name":22,"affiliation":5,"role":23},"Pankti Reid","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","(773) 702-1234","pankti.reid@bsd.uchicago.edu",{"name":30,"role":26,"phone":10,"phoneExt":10,"email":31},"Mohamed Ali","Mohamed.Ali@bsd.uchicago.edu",[33],{"facility":34,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The University of Chicago","Chicago","Illinois","60637","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},[47,50,52],{"name":48,"role":26,"phone":10,"phoneExt":10,"email":49},"Pankti Reid, MD","Pankti.Reid@bsd.uchicago.edu",{"name":51,"role":26,"phone":10,"phoneExt":10,"email":31},"Mohamed Ali, MD",{"name":48,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651093","pharmacokinetic-study-of-therapeutic-plasma-exchange-100651093",false,"NCT07756242","Pharmacokinetic Study of Therapeutic Plasma Exchange","A Phase 1 Pharmacokinetic Study of Therapeutic Plasma Exchange for Severe Immune-Related Adverse Events From Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosis of any malignancy.\n* Receiving or recently received an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or combination ICI therapy. Eligible agents may include, but are not limited to, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, and ipilimumab.\n* Received an ICI within 12 weeks prior to planned enrollment, or within a timeframe considered appropriate by the PI for PK evaluation based on the specific ICI agent, dosing history, and assay feasibility.\n* Suspected or confirmed severe or clinically significant immune-related adverse event for which the treating clinical team considers TPE\u002FPLEX clinically appropriate.\n* Planned to undergo or currently undergoing TPE\u002FPLEX at the University of Chicago Medicine.\n* Approval from the patient's primary clinical service for study participation.\n* Able to provide written informed consent, or has a legally authorized representative able to provide consent if permitted by the IRB-approved consent process.\n* In the opinion of the treating team and study team, PK blood sample collection can be performed without delaying or interfering with clinically indicated care.\n\nExclusion Criteria:\n\n* No prior exposure to an immune checkpoint inhibitor.\n* TPE\u002FPLEX is being performed for an indication unrelated to a suspected or confirmed ICI-associated immune-related adverse event.\n* Inability to provide informed consent and no legally authorized representative is available, if applicable.\n* PK blood sample collection is not feasible without delaying, altering, or interfering with clinically indicated care.\n* Any condition that, in the opinion of the investigator or treating team, would make participation in the research procedures unsafe or inappropriate.","ALL","18 Years",{"count":65,"type":66},15,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to characterize the pharmacokinetics of one or more ICIs during and after TPE\u002FPLEX in patients with severe irAEs.",[70],"Immune-related Adverse Event",[72,73,74,75,76,77,78,79],"Therapeutic plasma exchange","TPE","Immune Checkpoint Inhibitors","Immune-related Adverse Events","Pharmacokinetics","Pembrolizumab","Nivolumab","Ipilimumab","NOT_YET_RECRUITING","2026-08-05",{"date":83,"type":84},"2026-08-10","ACTUAL",{"date":86,"type":66},"2026-11",{"date":88,"type":66},"2028-02",{"name":5,"class":6},1]