[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589602":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":16,"locations":25,"responsibleParty":47,"collaborators":7,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":7,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":58,"phases":7,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":28,"whyStopped":7,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"ImmunityBio, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","nogapendekin-alfa inbakicept","1.0mg nogapendekin-alfa inbakicept (NAI) administered by subcutaneous injection no less than every 3 weeks and no more frequently than every 2 weeks between doses in combination with the standard of care schedule of chemotherapy, immunotherapy, and\u002For radiation therapy. Patients who are known HIV+ will be dosed with NAI at 0.5 mg",[14,15],"NAI","N-803",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Mark Nelson","CONTACT","213-414-3566","mark.nelson@immunitybio.com",{"name":23,"role":19,"phone":7,"phoneExt":7,"email":24},"Atessa Kiani, MD","atessa.kiani@immunitybio.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Chan Soon - Shiong Institute for Medicine","AVAILABLE","El Segundo","California","90245","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-118.41647,33.91918,{"lat":38,"lon":37},[41,44],{"name":42,"role":19,"phone":7,"phoneExt":7,"email":43},"Mini Gill","Jaya.Gill@cssifm.org",{"name":45,"role":46,"phone":7,"phoneExt":7,"email":7},"Tara Seery, MD","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100589602","expanded-access-use-of-nogapendekin-alfa-inbakicept-in-the-reversal-and-maintenance-of-absolute-lymphocyte-count-alc-for-the-treatment-of-lymphopenia-induced-by-chemotherapy-immunotherapy-andor-radiation-therapy-100589602",false,"NCT06956547","Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and\u002For Radiation Therapy","ResQ117EX-ALC: Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and\u002For Radiation Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Adult patients with solid tumors who progressed on standard-of-care treatment chemotherapy and\u002For immunotherapy and\u002For radiation therapy requiring second line or greater standard-of-care treatment with:\n\n   * Chemotherapy and\u002For\n   * Radiation therapy and\u002For\n   * Immune checkpoint inhibitor therapy and\u002For any therapy investigator deems appropriate at that institution\n3. Lymphocyte status meeting ONE of these conditions:\n\n   * Baseline absolute lymphocyte count (ALC) \\\u003C1,500 cells\u002FμL (mild lymphopenia) prior to treatment initiation in first line therapy or ALC \\\u003C1000 cells\u002FμL (severe lymphopenia) during and or following progression after first line therapy\n   * Anticipated treatment-induced lymphopenia (ALC reduction ≥20% from baseline based on reduction during first line therapy)\n   * Persistent lymphopenia (ALC \\\u003C1000 cells\u002FμL for \\>2 months during first line therapy treatment)\n\nExclusion Criteria:\n\n1. Active uncontrolled autoimmune disease requiring immunosuppression\n2. Participants with liquid tumors\n3. Concurrent solid organ transplantation","ALL","18 Years","EXPANDED_ACCESS","This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, immunotherapy, and\u002For radiation therapy who may benefit from its use, and who are ineligible to participate in a clinical trial using NAI. The primary objective of this protocol is to evaluate the reversal and maintenance of absolute lymphocyte count (ALC) with NAI.",[61],"Lymphopenia",[63,64,65,66,67],"lymphopenia","lymphopenia induced by chemotherapy","lymphopenia induced by radiation therapy","lymphopenia induced by immunotherapy","absolute lymphocyte count","2025-10-10",{"date":70,"type":71},"2025-10-14","ACTUAL",{"name":5,"class":6},1]