{"entity":{"id":"zuma-2","kind":"trial","name":"ZUMA-2","aka":[],"tldr":"ZUMA-2 showed that CD19 CAR-T cells could produce deep and lasting remissions in mantle cell lymphoma that had stopped responding to BTK inhibitors, a group that previously had few options.","summary":"ZUMA-2 was a single-arm phase 2 study of brexucabtagene autoleucel (KTE-X19), a CD19-directed CAR-T manufactured with a process that removes circulating lymphoma cells, in patients with relapsed or refractory mantle cell lymphoma after up to five prior therapies including a BTK inhibitor. The primary endpoint was objective response rate by independent review.\n\nMost treated patients responded and a majority achieved complete remission, with durable responses in a substantial share at long follow-up, including patients with TP53 mutations and blastoid morphology. Cytokine release syndrome and neurological events were common but largely reversible. The product was approved in the United States in July 2020, the first CAR-T for mantle cell lymphoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02601313","url":"https://clinicaltrials.gov/study/NCT02601313"}],"tags":["subtype-trials"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["brexucabtagene-autoleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michael-wang"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02601313","phase":"2","setting":"Relapsed or refractory mantle cell lymphoma after a BTK inhibitor: single-arm brexucabtagene autoleucel CAR-T","sponsor":"Kite (Gilead)","result":"High objective and complete response rates with durable remissions in mantle cell lymphoma after BTK inhibitor failure; approved in July 2020.","started":"2015-11-09","startedType":"actual","yearReported":2020,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (independent review, primary efficacy analysis)","primary":true,"unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":93,"note":"95% CI 84 to 98; median follow-up 12.3 months"}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Complete response (primary efficacy analysis)","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":67,"note":"95% CI 53 to 78"}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Objective response (intention to treat)","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":74,"value":85}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":61}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":83}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Grade 3 or higher cytokine release syndrome","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":68,"value":15}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Grade 3 or higher neurologic events","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":68,"value":31}],"source":"https://doi.org/10.1056/nejmoa1914347"}]},"route":"/trials/zuma-2/","neighbours":{"cancer":[{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-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":"brexucabtagene-autoleucel","kind":"drug","name":"Brexucabtagene autoleucel","route":"/drugs/brexucabtagene-autoleucel/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"person":[{"id":"michael-wang","kind":"person","name":"Michael L. Wang","route":"/people/michael-wang/"}],"term":[{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"}]}}