{"entity":{"id":"lummicar-1","kind":"trial","name":"LUMMICAR STUDY 1","aka":[],"tldr":"The Chinese trial behind zevor-cel's approval for multiple myeloma, showing deep and lasting responses with a fully human BCMA CAR-T.","summary":"Phase 1/2 single-arm study at Chinese centres; the phase 2 report (Experimental Hematology and Oncology 2025) described high overall and complete response rates, deep minimal residual disease negativity and predominantly low-grade cytokine release syndrome. Basis of NMPA approval in February 2024. A parallel North American study (LUMMICAR STUDY 2) was run by CARsgen before it refocused on China.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03975907","url":"https://clinicaltrials.gov/study/NCT03975907"},{"label":"Exp Hematol Oncol 2025","url":"https://doi.org/10.1186/s40164-025-00710-y"}],"tags":["china"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["zevorcabtagene-autoleucel"],"companies":["carsgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-chen-exp-hematol-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03975907","phase":"1/2","setting":"Relapsed or refractory multiple myeloma after three or more lines, China: single-arm study of zevorcabtagene autoleucel (CT053)","sponsor":"CARsgen Therapeutics","started":"2019-06-10","startedType":"actual","yearReported":2024,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review committee)","primary":true,"unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":92.2,"note":"102 infused of 125 apheresed; median follow-up 20.3 months; DOR, PFS and OS not mature"}],"ci":[85.13,96.55],"source":"https://doi.org/10.1186/s40164-025-00710-y"},{"endpoint":"Stringent complete response","unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":68.6,"note":"A further 2.9% reached complete response"}],"source":"https://doi.org/10.1186/s40164-025-00710-y"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":90.2,"note":"Grade 3-4 in 6.9%; ICANS in 2 patients, both grade 1"}],"source":"https://doi.org/10.1186/s40164-025-00710-y"}],"replication":"Single-arm phase 2 at 23 Chinese centres (patients with prior BCMA-directed or CAR-T therapy excluded). Consistent with FUMANBA-1 (eque-cel, ORR 96%) and with the North American LUMMICAR STUDY 2 dose-finding cohort; no randomised trial against standard regimens."},"route":"/trials/lummicar-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":"zevorcabtagene-autoleucel","kind":"drug","name":"Zevorcabtagene autoleucel","route":"/drugs/zevorcabtagene-autoleucel/"}],"company":[{"id":"carsgen","kind":"company","name":"CARsgen Therapeutics","route":"/companies/carsgen/"}],"paper":[{"id":"paper-chen-exp-hematol-oncol","kind":"paper","name":"Phase II study of zevorcabtagene autoleucel, a fully human BCMA-targeting CAR T cell therapy, in patients with relapsed/refractory multiple myeloma","route":"/key-papers/paper-chen-exp-hematol-oncol/"}]}}