{"entity":{"id":"fumanba-1","kind":"trial","name":"FUMANBA-1","aka":[],"tldr":"The single-arm trial that won eque-cel its approval in China, with almost every patient responding and most reaching deep remissions.","summary":"Multicentre single-arm study reported in JAMA Oncology 2024: objective responses in about 96% of infused patients, high rates of stringent complete response and minimal residual disease negativity, durable responses including in patients previously exposed to CAR-T, and mostly grade 1 to 2 cytokine release syndrome. Basis of NMPA approval in June 2023, China's first fully human BCMA CAR-T.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT05066646","url":"https://clinicaltrials.gov/study/NCT05066646"},{"label":"JAMA Oncol 2024","url":"https://doi.org/10.1001/jamaoncol.2024.4879"}],"tags":["china"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["equecabtagene-autoleucel"],"companies":["iaso-bio","innovent"],"institutions":["tongji-hospital-wuhan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-li-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05066646","phase":"1/2","setting":"Relapsed or refractory multiple myeloma after three or more lines, China: single-arm study of equecabtagene autoleucel","sponsor":"IASO Biotherapeutics and Innovent Biologics","result":"ORR about 96% in infused patients (JAMA Oncol 2024).","started":"2020-04-01","startedType":"actual","yearReported":2024,"enrolled":103,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (efficacy-evaluable)","primary":true,"unit":"%","arms":[{"name":"Equecabtagene autoleucel 1.0 × 10^6 CAR+ T cells/kg","n":101,"value":96,"note":"97 of 101 evaluable patients; 103 infused; median follow-up 13.8 months (data cut September 2022)"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Complete response or better","unit":"%","arms":[{"name":"Equecabtagene autoleucel","n":103,"value":74.3,"note":"75 of 103 as reported"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"MRD negativity (10^-5)","unit":"%","arms":[{"name":"Equecabtagene autoleucel","value":95,"note":"96 patients"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"Equecabtagene autoleucel","value":78.8,"note":"Median PFS not reached"}],"ci":[68.6,86],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Equecabtagene autoleucel","n":103,"value":93.2,"note":"Grade 1-2 in 92.3%; ICANS 1.9% (all grade 1-2)"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"}],"replication":"Single-arm phase 1b/2 across 14 Chinese centres; no randomised comparison. The response rate sits alongside zevor-cel (LUMMICAR STUDY 1, ORR 92.2%) and cilta-cel (CARTITUDE-1), so the depth of response is consistent across fully human and llama-derived BCMA CAR-Ts; 9 of 12 patients previously exposed to another CAR-T responded."},"route":"/trials/fumanba-1/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"drug":[{"id":"equecabtagene-autoleucel","kind":"drug","name":"Equecabtagene autoleucel","route":"/drugs/equecabtagene-autoleucel/"}],"company":[{"id":"iaso-bio","kind":"company","name":"IASO Biotherapeutics","route":"/companies/iaso-bio/"},{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"institution":[{"id":"tongji-hospital-wuhan","kind":"institution","name":"Tongji Hospital, Huazhong University of Science and Technology","route":"/institutions/tongji-hospital-wuhan/"}],"paper":[{"id":"paper-li-jama-oncol","kind":"paper","name":"Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma: The FUMANBA-1 Nonrandomized Clinical Trial","route":"/key-papers/paper-li-jama-oncol/"}]}}