{"entity":{"id":"zuma-5","kind":"trial","name":"ZUMA-5","aka":[],"tldr":"ZUMA-5 showed that a single infusion of CD19 CAR-T cells put most people with heavily pretreated follicular lymphoma into remission, and that many of those remissions have lasted for years.","summary":"ZUMA-5 was a single-arm phase 2 study of axicabtagene ciloleucel, an autologous CD19-directed CAR-T product, in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma after at least two prior lines including an anti-CD20 antibody and an alkylating agent. The primary endpoint was objective response rate by independent review.\n\nThe great majority of patients with follicular lymphoma responded and most of those responses were complete; with long follow-up roughly half remained progression-free at four years, and cytokine release syndrome and neurological events were mostly manageable. Axicabtagene ciloleucel received accelerated approval in the United States for follicular lymphoma in March 2021, the first CAR-T for an indolent lymphoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03105336","url":"https://clinicaltrials.gov/study/NCT03105336"}],"tags":["subtype-trials"],"related":["lymphoma-roadmap","elara","lymphoma-tx-pod24"],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["axicabtagene-ciloleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["caron-jacobson"],"bottlenecks":[],"keyPapers":["paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03105336","phase":"2","setting":"Relapsed or refractory follicular or marginal zone lymphoma after two or more lines of therapy: single-arm axicabtagene ciloleucel CAR-T","sponsor":"Kite (Gilead)","result":"High objective and complete response rates in relapsed follicular lymphoma with durable remissions; accelerated approval in March 2021.","started":"2017-06-06","startedType":"actual","yearReported":2021,"enrolled":159,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (independent review, primary analysis)","primary":true,"unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":104,"value":92,"note":"95% CI 85 to 97; median follow-up 17.5 months; 84 follicular and 20 marginal zone lymphoma"}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Complete response (primary analysis)","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":104,"value":74}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Grade 3 or worse cytokine release syndrome","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":148,"value":7}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Grade 3-4 neurological events","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":148,"value":19}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"}]},"route":"/trials/zuma-5/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"trial":[{"id":"elara","kind":"trial","name":"ELARA","route":"/trials/elara/"}],"term":[{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"lymphoma-tx-pod24","kind":"term","name":"POD24: progression of follicular lymphoma within two years, and why it changes the plan","route":"/terms/lymphoma-tx-pod24/"}],"cancer":[{"id":"malt-lymphoma","kind":"cancer","name":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)","route":"/cancers/malt-lymphoma/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"marginal-zone-lymphoma","kind":"cancer","name":"Marginal zone lymphoma","route":"/cancers/marginal-zone-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"person":[{"id":"caron-jacobson","kind":"person","name":"Caron A. Jacobson","route":"/people/caron-jacobson/"}],"paper":[{"id":"paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022","kind":"paper","name":"Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial","route":"/key-papers/paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022/"},{"id":"paper-casulo-pod24-follicular-lymphoma-jco-2015","kind":"paper","name":"Early relapse of follicular lymphoma after R-CHOP defines patients at high risk for death: an analysis from the National LymphoCare Study","route":"/key-papers/paper-casulo-pod24-follicular-lymphoma-jco-2015/"},{"id":"paper-elara-tisagenlecleucel-follicular-nat-med-2022","kind":"paper","name":"Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial","route":"/key-papers/paper-elara-tisagenlecleucel-follicular-nat-med-2022/"}]}}