[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653345":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":52,"studyPopulation":42,"armGroups":53,"interventions":66,"overallOfficials":79,"centralContacts":83,"locations":42,"responsibleParty":92,"collaborators":42,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":42,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":42,"enrollmentInfo":103,"targetDuration":42,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":120,"whyStopped":42,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":42},{"fullName":5,"class":6},"ImmunityBio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"28-day all-cause mortality rate","Proportion of participants who die from any cause by Day 28 after the first dose of study treatment.","From Day 1 (first NAI dose) through Day 28",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Change in Absolute Lymphocyte Count (ALC) From Baseline","Change in absolute lymphocyte count (cells\u002FµL) from baseline (Day 1 pre-dose) at each assessment through the end of hospital stay, using local complete blood counts with differential collected at least every 3 days.","Baseline (Day 1 pre-dose) through end of hospital stay (up to 90 days)",{"measure":19,"description":20,"timeFrame":21},"90-Day Survival Rate","Proportion of participants who are alive 90 days after the first dose of nogapendekin alfa inbakicept (NAI). Survival status will be determined by review of records and\u002For direct contact (in person or by phone) on Day 90 after Day 1 dosing.","From Day 1 (first NAI dose) through Day 90",{"measure":23,"description":24,"timeFrame":25},"Proportion of Participants Alive and Free of Organ Support at Day 28","Proportion of participants who are alive and not requiring mechanical ventilation, vasopressors, or renal replacement therapy on Day 28 after the first NAI dose. Organ support status will be determined from ICU\u002Fhospital records.","Day 28 after Day 1 (first NAI dose)",{"measure":27,"description":28,"timeFrame":29},"Change From Baseline in SOFA Score","Change from baseline in Sequential Organ Failure Assessment (SOFA) score at each daily intensive care unit (ICU) assessment. The SOFA score evaluates dysfunction across six organ systems: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ system is scored from 0 to 4, resulting in a total score ranging from 0 to 24. Higher scores indicate greater organ dysfunction and a worse clinical outcome. Change from baseline is calculated as the score at each daily ICU assessment minus the baseline score; a positive change indicates worsening organ dysfunction, while a negative change indicates improvement.","Baseline (Day 1) through end of ICU stay (up to 90 days)",{"measure":31,"description":32,"timeFrame":33},"Time to ICU Discharge","Number of days from ICU admission at the index sepsis episode to ICU discharge, with death before ICU discharge treated as a competing event in analysis.","From ICU admission to ICU discharge or death (up to 90 days)",{"measure":35,"description":36,"timeFrame":37},"Time to Hospital Discharge","Number of days from hospital admission at the index sepsis episode to hospital discharge, with death before discharge treated as a competing event in analysis.","From hospital admission to hospital discharge or death (up to 90 days)",{"measure":39,"description":40,"timeFrame":41},"Incidence of Secondary Infections Through Day 28","Number and proportion of participants who develop one or more new infections after enrollment that are distinct from the index infection, based on clinical diagnosis and culture or other microbiologic testing.","From Day 1 through Day 28",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":50},"SINGLE","Participant, Care Provider, Investigator, Outcomes Assessor, as applicable",[51],"PARTICIPANT","This is a randomized, double-blind, placebo-controlled, parallel-assignment Phase 2a study evaluating NAI plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Approximately 50 participants will be randomized in a 1:1 ratio. The first 10 randomized participants will comprise a safety run-in, with approximately 5 participants assigned to each treatment arm. Safety data will be reviewed by the designated safety review committee or DSMB before enrollment of the remaining participants proceeds.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"NAI Plus Standard of Care","EXPERIMENTAL","Participants receive NAI 1.2 mg subcutaneously plus protocol-defined standard of care.",[59],"Drug: Nogapendekin alfa inbakicept (NAI)",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo plus standard of care","PLACEBO_COMPARATOR","Participants receive matching placebo subcutaneously plus protocol-defined standard of care.",[65],"Drug: Placebo",[67,75],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","Nogapendekin alfa inbakicept (NAI)","Subcutaneous administration of nogapendekin alfa inbakicept (NAI; N-803, ANKTIVA®), a recombinant human IL-15 receptor agonist complex (IL-15N72D:IL-15RαSu\u002FIgG1 Fc), at a fixed dose of 1.2 mg (0.6 mL at 2 mg\u002FmL) on Day 1 (within 72 hours of sepsis recognition), with additional 1.2 mg doses on Day 14 if still hospitalized and on Day 21 if still hospitalized with ALC ≤ 1,000 cells\u002FµL, given in combination with protocolized Surviving Sepsis Campaign-based standard of care.",[55],[73,74],"N-803","ANKTIVA",{"type":68,"name":76,"description":77,"armGroupLabels":78,"otherNames":42},"Placebo","Matching placebo administered subcutaneously according to the same dosing schedule and under the same conditions as nogapendekin alfa inbakicept (NAI), in combination with standard of care. The placebo is designed to maintain blinding and contains no active NAI.",[61],[80],{"name":81,"affiliation":5,"role":82},"Lennie Sender, MD","STUDY_CHAIR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":42,"email":88},"Joseph Ward","CONTACT","3236933913","joseph.ward@immunitybio.com",{"name":90,"role":86,"phone":91,"phoneExt":42,"email":88},"Jim Albert","310-486-6180",{"type":93,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100653345","phase-1-nai-nogapendekin-alfa-inbakicept-plus-standard-of-care-in-critically-ill-adults-with-sepsis-100653345",false,"NCT07783789","NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis","Phase 2a, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Nogapendekin Alfa Inbakicept (NAI) Plus Standard of Care (SOC) Compared to SOC Alone in Critically Ill Adults With Sepsis","Inclusion Criteria\n\n* Age ≥18 years at the time of informed consent.\n* Admission to the ICU with sepsis, without septic shock, per Sepsis-3 criteria, operationalized as a SOFA increase of at least 2 points attributable to suspected or confirmed infection.\n* ALC ≤1,000 cells\u002FµL in two consecutive measurements separated by at least 12 hours during the 72-hour screening window.\n* Documented or strongly suspected bacterial, viral, fungal, or mixed infection with reasonable diagnostic workup initiated.\n* Receiving guideline-directed standard of care according to the 2026 Surviving Sepsis Campaign Guidelines.\n* Able to receive the first dose of NAI within 72 hours of sepsis recognition, targeted within 12 hours of eligibility confirmation.\n* Ability to obtain written informed consent from the participant or legally authorized representative.\n* Agreement to practice effective contraception, as applicable, by females of childbearing potential and nonsterile males.\n\nExclusion Criteria\n\n* Severe hepatic failure, including Child-Pugh class C, ALT or AST ≥3 times the ULN with total bilirubin \\>2 times the ULN, or ALT or AST ≥5 times the ULN.\n* Septic shock at screening or at the time of the first dose.\n* Active malignancy treated with cytotoxic chemotherapy, radiotherapy, or checkpoint-inhibitor therapy within 30 days before sepsis onset.\n* History of solid-organ transplantation.\n* Hematopoietic stem-cell transplantation within the prior 100 days.\n* Active graft-versus-host disease requiring systemic immunosuppression.\n* Known hypersensitivity to NAI, IL-15, recombinant IL-15 receptor-alpha sushi domain, or human IgG1 Fc.\n* Pregnancy.\n* Breastfeeding.\n* Active treatment with another investigational therapy.\n* Participation in another interventional clinical trial within 30 days before enrollment.\n* A clinical condition or treatment limitation that, in the Investigator's opinion, precludes meaningful participation or follow-up.\n* Expected death within 24 hours.\n* Comfort-care-only orders that preclude protocol-mandated assessments.","ALL","18 Years",{"count":104,"type":105},50,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia. Participants will be randomized approximately 1:1 and treated under double-blind conditions. The study includes a safety run-in for the first 10 randomized participants, followed by enrollment of the remaining participants after safety review. Outcomes include safety, 28-day survival, absolute lymphocyte count recovery, organ-support-free status, organ dysfunction, and ICU and hospital outcomes",[111],"Sepsis",[111,113,114,115,116,117,73,74,118,119],"Critical illness","Intensive care unit","Persistent lymphopenia","Absolute lymphocyte count","Nogapendekin alfa inbakicept","IL-15 receptor agonist","Immunotherapy in sepsis","NOT_YET_RECRUITING","2026-09-22",{"date":123,"type":124},"2026-09-25","ACTUAL",{"date":126,"type":105},"2026-10-15",{"date":128,"type":105},"2028-08-13",{"name":5,"class":6}]