[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462776":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":20,"overallStatus":23,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tadekinig alfa","EXPERIMENTAL","* Injection #1\u002FDay 1: As clinically indicated in accordance with Figure 1.1-1.\n* Repeat Injection(s): Missed doses will not be made up.\n* Injection #2\u002FDay 3: Approximately 48 hours (+\u002F- 5 hours) after receipt of the 1st injection.\n* Injection #3\u002FDay 5: Approximately 48 hours (+\u002F- 5 hours) after receipt of the 2nd injection.\n* Continued Dosing (Optional): Approximately q48-72 hours; If the subject is responsive to initial therapy, but has ongoing symptoms of CRS\u002FCRHLS.\n* Retreatment (Optional): May be considered",[13],"Drug: Tadekinig alfa (IL-18BP)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tadekinig alfa (IL-18BP)","Tadekinig alfa will be administered via subcutaneous injection. The site of subcutaneous injection should be rotated to avoid injection site reactions; e.g. the outside of the thighs, arms, and the various quadrants of the anterior abdominal wall.\n\n* Injection #1\u002FDay 1:\n\n  o Loading dose of 4 mg\u002Fkg; Maximum dose of 350 mg.\n* Repeat Injection(s): 2 mg\u002Fkg\u002Finjection; Maximum dose of 160 mg\u002Finjection. Missed doses will not be made up.\n\n  * Injection #2\u002FDay 3: Approximately 48 hours (+\u002F- 5 hours) after receipt of the 1st injection.\n  * Injection #3\u002FDay 5: Approximately 48 hours (+\u002F- 5 hours) after receipt of the 2nd injection.\n  * Continued Dosing (Optional): Approximately q48-72 hours; If the subject is responsive to initial therapy, but has ongoing symptoms of CRS\u002FCRHLS.",[9],null,[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-75.16362,39.95238,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Joan Gilmore","CONTACT","215-573-2540","joan.gilmore@pennmedicine.upenn.edu",{"name":42,"role":43,"phone":20,"phoneExt":20,"email":20},"David Porter, MD","PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100462776","early-phase-1-tadekinig-alfa-il-18bp-rescue-therapy-for-car-t-cell-related-cytokine-release-syndrome-crs-and-hlh-like-syndrome-100462776",false,"NCT05306080","Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome","Pilot, Open-Label Study Evaluating the Safety and Feasibility of Using Rescue Therapies for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome","Inclusion Criteria:\n\n1. Signed, written informed consent\n2. Male or female patients age ≥ 18 years\n3. Have been co-enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial.\n4. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol\n\nExclusion Criteria:\n\n1. Pregnant or nursing (lactating) women.\n2. Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).","ALL","18 Years",{"count":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[60],"EARLY_PHASE1","This is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).",[63,64],"CRS - Cytokine Release Syndrome","HLH","2026-02-27",{"date":67,"type":68},"2026-03-03","ACTUAL",{"date":70,"type":68},"2022-04-17",{"date":72,"type":57},"2028-04",{"name":5,"class":6},1]