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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.
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.
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. Connects to PD-L1.
1.CAR001 slips into a pocket on PD-L1.
treatment of malignant glioma
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
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Query for this drug: (TITLE:"CAR001" OR ABSTRACT:"CAR001" OR TITLE:"HLA-G-CAR.BiTE allogeneic gamma delta T cells" OR ABSTRACT:"HLA-G-CAR.BiTE allogeneic gamma delta T cells") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about CAR001, not a curated reading list.
Shares Glioma & glioblastoma and the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
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