{"entity":{"id":"nct04094311","kind":"trial","name":"Study of Out of Specification for Tisagenlecleucel","aka":[],"tldr":"A phase 3 trial of Tisagenlecleucel in diffuse large b-cell lymphoma, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study of Out of Specification for Tisagenlecleucel is a phase 3 interventional study registered as NCT04094311 by Novartis Pharmaceuticals, with 200 participants planned, started 2019-11-21 and due to reach its primary completion in 2027-03-31. Interventions recorded: CTL019. Conditions listed: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04094311","url":"https://clinicaltrials.gov/study/NCT04094311"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04094311","phase":"3","setting":"A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication","sponsor":"Novartis Pharmaceuticals","participation":[{"nct":"NCT04094311","source":"https://clinicaltrials.gov/study/NCT04094311","fetchedAt":"2026-10-07T16:53:14.124Z","studySha256":"3a15aa912d01ded748a465f0811f851fad7e4e8eb0ce9dd18877a1a747e42e87","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-15","leadSponsor":"Novartis Pharmaceuticals","collaboratorCount":0,"minimumAge":"0 Years","maximumAge":"100 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":200,"enrolmentType":"ESTIMATED","siteCount":55,"recruitingSiteCount":49,"countries":["Canada","Japan"]}],"started":"2019-11-21","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04094311/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"idea":[{"id":"idea-reg-in-vivo-cart-off-the-shelf-vial","kind":"idea","name":"In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma","route":"/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/"},{"id":"idea-reg-non-viral-cart-manufacturing","kind":"idea","name":"Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route","route":"/ideas/idea-reg-non-viral-cart-manufacturing/"}]}}