[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637440":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":46,"studyPopulation":11,"armGroups":47,"interventions":61,"overallOfficials":11,"centralContacts":74,"locations":80,"responsibleParty":139,"collaborators":11,"id":141,"slug":11,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":11,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":11,"enrollmentInfo":149,"targetDuration":11,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":126,"whyStopped":11,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"MiNK Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Deaths (All-cause Mortality)",null,"Day 1 through Day 28",[14,16,18,20,22,24,26,28,30],{"measure":15,"description":11,"timeFrame":12},"Number of Oxygenation Support-free Days",{"measure":17,"description":11,"timeFrame":12},"Time to Resolution of Hypoxemia",{"measure":19,"description":11,"timeFrame":12},"Number of Ventilator-free Days",{"measure":21,"description":11,"timeFrame":12},"Number of Intensive Care Unit-free Days",{"measure":23,"description":11,"timeFrame":12},"Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections",{"measure":25,"description":11,"timeFrame":12},"Number of Antibiotic-free Days",{"measure":27,"description":11,"timeFrame":12},"Time to Hospital Discharge",{"measure":10,"description":11,"timeFrame":29},"Day 1 through Day 90",{"measure":31,"description":32,"timeFrame":33},"Change From Baseline in Cytokine Profiles","Cytokine profiles analyzed may include interleukin-6, tumor necrosis factor-alpha, interleukin-1-beta, interleukin-1 receptor antagonist, soluble receptor for advanced glycation end product, angiopoietin-1 and -2, and tumor necrosis factor receptor 1.","Baseline, Day 3, Day 7, Day 14",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":39,"maskingDescription":40,"whoMasked":41},"QUADRUPLE","The Run-in Phase is open label and non-randomized, Phase 2 is double blind and randomized.",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This trial will be conducted in 2 parts (Run-in Phase; Phase 2). The Run-in Phase is designed to characterize the baseline population of the site, where participants will receive open-label agenT-797 plus SOC. After completion of the Run-in Phase, participants will be enrolled and randomized to receive either agenT-797 plus SOC or placebo plus SOC during the double-blinded Phase 2.",[48,55],{"label":49,"type":50,"description":51,"interventionNames":52},"agenT-797 plus SOC","EXPERIMENTAL","Participants will receive agenT-797 and SOC.",[53,54],"Drug: agenT-797","Drug: Standard of Care (SOC)",{"label":56,"type":57,"description":58,"interventionNames":59},"Placebo plus SOC","PLACEBO_COMPARATOR","Participants will receive placebo and SOC.",[60,54],"Drug: Placebo",[62,67,70],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":11},"DRUG","agenT-797","Intravenous infusion",[49],{"type":63,"name":68,"description":65,"armGroupLabels":69,"otherNames":11},"Placebo",[56],{"type":63,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"Standard of Care (SOC)","Antimicrobial therapy and corticosteroids per applicable guidelines.",[56,49],[75],{"name":76,"role":77,"phone":78,"phoneExt":11,"email":79},"MiNK Therapeutics Clinical Trial Information","CONTACT","1-212-994-8250","webmaster@minktherapeutics.com",[81,99,112,124],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"UCSF Medical Center at Parnassus Heights","NOT_YET_RECRUITING","San Francisco","California","94143","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-122.41942,37.77493,{"lat":93,"lon":92},[96],{"name":97,"role":98,"phone":11,"phoneExt":11,"email":11},"Michael Matthay, MD","PRINCIPAL_INVESTIGATOR",{"facility":100,"status":83,"city":101,"state":102,"zip":103,"country":87,"countryCode":88,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Children's Memorial Hermann Hospital","Houston","Texas","77030",{"type":90,"coordinates":105},[106,107],-95.36327,29.76328,{"lat":107,"lon":106},[110],{"name":111,"role":98,"phone":11,"phoneExt":11,"email":11},"Charles Cox, MD",{"facility":113,"status":83,"city":114,"state":102,"zip":115,"country":87,"countryCode":88,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University Hospital","San Antonio","78229",{"type":90,"coordinates":117},[118,119],-98.49363,29.42412,{"lat":119,"lon":118},[122],{"name":123,"role":98,"phone":11,"phoneExt":11,"email":11},"Donald Jenkins, MD",{"facility":125,"status":126,"city":127,"state":11,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"First Lviv Territorial Medical Union","RECRUITING","Lviv","79059","Ukraine","UA",{"type":90,"coordinates":132},[133,134],24.02324,49.83826,{"lat":134,"lon":133},[137],{"name":138,"role":98,"phone":11,"phoneExt":11,"email":11},"Chirstina Orlysnka, MD",{"type":140,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100637440",false,"NCT07615010","A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure","Phase 2 Adaptive Randomized, Placebo -Controlled Trial of agenT-797 + Standard of Care Vs. Placebo + Standard of Care in Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure (AHRF) By Global ARDS Criteria","Key Inclusion Criteria:\n\n* Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion\n* Acute hypoxemic respiratory failure (AHRF)\n* Evidence of moderate to severe acute respiratory distress syndrome (ARDS) based on Global ARDS criteria\n* Onset of severe pneumonia with AHRF ≤7 days prior to informed consent\n\nKey Exclusion Criteria:\n\n* More than two vasopressors to maintain a mean arterial pressure ≥65 millimeters of mercury at the time of informed consent\n* Pregnancy or breastfeeding\n* History of cytokine release syndrome, as documented in the medical record or reported by the participant, legally authorized representative, or close relative\n* Current participation in another interventional clinical trial, or receipt of an investigational medicinal product within 30 days prior to screening, unless reviewed and approved in writing by the medical monitor\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":150,"type":151},90,"ESTIMATED","INTERVENTIONAL",[154],"PHASE2","This clinical trial will evaluate the efficacy and safety of a single intravenous dose of agenT-797 administered in addition to standard of care (SOC), compared with placebo plus SOC, in reducing short-term mortality in adult participants with severe pneumonia and moderate to severe AHRF. All participants will receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS).",[157],"Pneumonia",[159,160,64],"Acute Hypoxemic Respiratory Failure","AHRF","2026-06-25",{"date":163,"type":164},"2026-06-26","ACTUAL",{"date":166,"type":164},"2026-05-26",{"date":168,"type":151},"2027-08",{"name":5,"class":6},4]