[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arovella Therapeutics Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632795","phase-1-study-of-ala-101-in-patients-with-cd19-positive-non-hodgkin-lymphoma-and-leukemia-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":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101",[26,27],"Non Hodgkin Lymphoma (NHL)","Leukaemia",[29,30,31,32,33,34],"C19+","Lymphoma","Leukemia","CART T CELL","iNKT","CAR iNKT","NOT_YET_RECRUITING","2026-04-06",{"date":38,"type":39},"2026-04-08","ACTUAL",{"date":41,"type":20},"2026-04-01",{"date":43,"type":20},"2030-08-30",{"name":45,"class":46},"Arovella Therapeutics Ltd","INDUSTRY",3,""]