{"entity":{"id":"car001","kind":"drug","name":"CAR001","aka":["HLA-G-CAR.BiTE allogeneic gamma delta T cells"],"tldr":"CAR001 is an off-the-shelf immune cell therapy from Ever Supreme Bio Technology, made from donor gamma delta T cells. It is in an early trial in solid tumours, and the FDA has given it orphan drug status for malignant glioma.","summary":"CAR001 is Ever Supreme Bio Technology's allogeneic CAR.BiTE gamma delta T-cell therapy. It is in the phase 1/2a trial NCT06150885 at China Medical University Hospital in Taichung; the company reports 15 patients treated in phase 1 with one complete response in recurrent glioblastoma and entry into phase 2a in 2026. On 21 September 2026 the FDA granted orphan drug designation for the treatment of malignant glioma to allogeneic gamma delta T cells modified by messenger RNA encoding a VHH-based CAR targeting HLA-G and a secretable BiTE targeting PD-L1, which matches the company's description of CAR001; the FDA record does not print the code.","status":"phase-2","asOf":"2026-11-04","links":[{"label":"Ever Supreme: CAR001 progress, July 2026","url":"https://en.ever-supreme.com.tw/news_detail/41"},{"label":"ClinicalTrials.gov: NCT06150885","url":"https://clinicaltrials.gov/study/NCT06150885"},{"label":"FDA orphan designation record","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1176726"}],"tags":["pipeline","orphan-designation"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["gamma-delta-t-cell-therapy"],"targets":["pdl1"],"drugs":[],"companies":["ever-supreme-bio-technology"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06150885"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"code":"CAR001","modality":"Allogeneic CAR gamma delta T-cell therapy","mechanism":"Donor gamma delta T cells carry a chimeric antigen receptor built from a single-domain (VHH) antibody against HLA-G and secrete a bispecific T-cell engager (BiTE) against PD-L1, so that the cells attack HLA-G-bearing tumour cells and recruit the patient's own T cells, as the FDA record and the developer describe it.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-09-21","type":"designation","region":"US","note":"FDA orphan drug designation for malignant glioma, granted to Ever Supreme Bio Technology for allogeneic gamma delta T cells with an HLA-G CAR and a secreted PD-L1 BiTE","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1176726","indication":"treatment of malignant glioma"}]},"route":"/drugs/car001/","neighbours":{"cancer":[{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"technology":[{"id":"gamma-delta-t-cell-therapy","kind":"technology","name":"Gamma-delta T cell therapy","route":"/technologies/gamma-delta-t-cell-therapy/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"company":[{"id":"ever-supreme-bio-technology","kind":"company","name":"Ever Supreme Bio Technology","route":"/companies/ever-supreme-bio-technology/"}],"trial":[{"id":"nct06150885","kind":"trial","name":"A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors","route":"/trials/nct06150885/"}]}}