[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632795":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":36,"locations":37,"responsibleParty":86,"collaborators":36,"id":88,"slug":36,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":36,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":36,"enrollmentInfo":96,"targetDuration":36,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":113,"whyStopped":36,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Arovella Therapeutics Ltd","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Dose Level 1","EXPERIMENTAL","50 × 10\\^6 CAR+ iNKT cells (starting dose level)",[13],"Drug: ALA-101",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment Dose Level -1","Dose level -1: 20 × 10\\^6 CAR+ iNKT cells (in case of DLTs on Dose Level 1)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Treatment Dose Level 2","150 × 10\\^6 CAR+ iNKT cells",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Treatment Dose Level 3","300 × 10\\^6 CAR+ iNKT cells",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Treatment Dose Level 4","500 × 10\\^6 CAR+ iNKT cells",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","ALA-101","Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide",[15,9,19,23,27],null,[38,57,72],{"facility":39,"status":36,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Royal Adelaide Hospital","Adelaide","South Australia","5000","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],138.59863,-34.92866,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":55,"phoneExt":36,"email":56},"Dr Danielle Blunt","CONTACT","08 7074 0000","Health.CALHNClinicalTrials@sa.gov.au",{"facility":58,"status":36,"city":59,"state":60,"zip":61,"country":43,"countryCode":44,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"The Alfred Hospital","Melbourne","Victoria","3004",{"type":46,"coordinates":63},[64,65],144.96332,-37.814,{"lat":65,"lon":64},[68],{"name":69,"role":54,"phone":70,"phoneExt":36,"email":71},"Dr Salvatore Fiorenza","(03) 9903 0122","acbd@monash.edu",{"facility":73,"status":36,"city":74,"state":60,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Epworth HealthCare","Richmond","3121",{"type":46,"coordinates":77},[78,79],145.00176,-37.81819,{"lat":79,"lon":78},[82],{"name":83,"role":54,"phone":84,"phoneExt":36,"email":85},"Dr Sumi Ratnasingam","03 9426 0555","EHBloodCancer@epworth.org.au",{"type":87,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100632795",false,"NCT07518329","Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.","A Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101, Allogeneic, Off-the-shelf, CD19-directed CAR-iNKT Cells in Patients With CD19+ Non-Hodgkin Lymphoma and Leukemia","Inclusion Criteria:\n\n* Over 18 years old\n* Confirmed Diagnoses of Confirmed diagnosis of CD19+ non-Hodgkins lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphatic Leukemia or Hairy Cell Leukemia\n* Life Expectancy greater than 3 months\n* Adequate Hepatic and Renal Function\n* Adequate Bone Marrow Function\n* Adequate ECG Vales\n* Agree to use appropriate contraception to avoid becoming pregnant for up to 12 months post treatment and agree not to donate sperm or ova for 12 months post treatment\n\nExclusion Criteria:\n\n* Prior anti-CD1d monoclonal antibody treatment\n* Prior allogeneic stem cell transplant except where the participant is greater than 100 days and does not have Graft Versus Host Disease (uncontrolled)\n* Prior Organ Transplant\n* Previous Malignancy in last 3 years that's active or been treated.\n* Current central nervous system involvement by lymphoma or leukaemia\n* Evidence of Cardiac Dysfunction\n* Active Autoimmune disease requiring systemic immunosuppressive therapy within the past 6 months.\n* Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n* History of Graft Vs Host Disease Grade 2 to 4\n* No active Graft Vs Host Disease following a minimum of 3 months withdrawal from all Graft Vs Host Disease treatments\n* Must not have received systemic anti-cancer therapy for the underlying malignancy within 6 weeks prior to the start of conditioning chemotherapy on Day -6.\n* Participants that have received autologous or allogenic CAR-T cell therapy within 3 months prior to commencing screening.\n* Use of systemic corticosteroids within 15 days of commencement of conditioning chemotherapy on Day -6 or other immunosuppressive drugs within 30 days\n* Recent major surgery (within 4 weeks prior to commencement of conditioning chemotherapy on Day -6) or planned major surgery within 8 weeks following ALA-101 infusion on Day 1.\n* Active infection requiring intravenous antibiotic, antifungal, or antiviral medication or hospital admission within 10 days prior to commencement of conditioning chemotherapy on Day -6\n* Severe (e.g., severe chronic obstructive pulmonary disease, severe Parkinson's disease) or poorly controlled (e.g., hypertension, diabetes, active inflammatory bowel disease) medical condition.\n* Vaccinated with a live vaccine within 28 days prior to commencement of conditioning chemotherapy on Day -6 or planned live vaccination within 6 months following ALA-101 infusion.\n\nAdditional criteria apply.","ALL","18 Years",{"count":97,"type":98},46,"ESTIMATED","INTERVENTIONAL",[101],"PHASE1","Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101",[104,105],"Non Hodgkin Lymphoma (NHL)","Leukaemia",[107,108,109,110,111,112],"C19+","Lymphoma","Leukemia","CART T CELL","iNKT","CAR iNKT","NOT_YET_RECRUITING","2026-04-06",{"date":116,"type":117},"2026-04-08","ACTUAL",{"date":119,"type":98},"2026-04-01",{"date":121,"type":98},"2030-08-30",{"name":5,"class":6},3]