{"entity":{"id":"tabelecleucel","kind":"drug","name":"Tabelecleucel","aka":["Ebvallo","ATA129","tab-cel"],"tldr":"Tabelecleucel is a bank of donor T cells trained against Epstein-Barr virus, approved in Europe in 2022 as the first off-the-shelf T-cell therapy, for EBV-driven lymphoma after transplant when rituximab has failed.","summary":"Atara Biotherapeutics built tabelecleucel from EBV-specific T-cell lines of healthy donors, selected for each patient by shared HLA alleles, so no manufacturing from the patient's own cells is needed. The European Commission approved it in December 2022 as Ebvallo for relapsed or refractory EBV-positive post-transplant lymphoproliferative disease after at least one prior therapy, the first allogeneic T-cell immunotherapy approved anywhere; the FDA issued a complete response letter in 2024 over manufacturing questions. Pierre Fabre markets it and runs trials in other EBV-associated diseases.","status":"approved","asOf":"2026-09-16","wikipedia":"https://en.wikipedia.org/wiki/Tabelecleucel","links":[{"label":"ClinicalTrials.gov: trials of Tabelecleucel","url":"https://clinicaltrials.gov/search?intr=Tabelecleucel"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["post-transplant-lymphoproliferative-disorder"],"sections":[],"technologies":["virus-specific-t-cells"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct03394365"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"modality":"Cell therapy: allogeneic off-the-shelf Epstein-Barr virus-specific T cells","mechanism":"T cells from healthy donors expanded against Epstein-Barr virus antigens and matched to the patient by HLA restriction; infused, they kill EBV-infected lymphoma cells.","approvals":[{"region":"EU","year":2022,"indication":"Relapsed or refractory EBV-positive post-transplant lymphoproliferative disease after at least one prior therapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tabelecleucel/","neighbours":{"cancer":[{"id":"post-transplant-lymphoproliferative-disorder","kind":"cancer","name":"Post-transplant lymphoproliferative disorder (PTLD)","route":"/cancers/post-transplant-lymphoproliferative-disorder/"}],"technology":[{"id":"virus-specific-t-cells","kind":"technology","name":"Virus-specific T cells","route":"/technologies/virus-specific-t-cells/"}],"trial":[{"id":"nct03394365","kind":"trial","name":"A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failu","route":"/trials/nct03394365/"},{"id":"nct04554914","kind":"trial","name":"A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases","route":"/trials/nct04554914/"}]}}