Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial - Nature Medicine

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In a phase 1 dose-escalation trial in patients with nine different types of solid tumors, MAGE-A4-specific T cells had an acceptable safety profile & exhibited an encouraging overall response rate in patients with synovial sarcoma. DavidHongMD TcellRx

This open-label, phase 1 trial was conducted at multiple centers in North America to evaluate the safety of afami-cel in HLA-A*02All patients underwent two pre-screening evaluations using different screening protocols : HLA testing for at least one HLA-A2 inclusion allele and absence of the exclusion allele HLA-A*02:05; and MAGE-A4 tumor biopsy testing using an anti-MAGE-A4 immunohistochemistry assay .

Patients must have had histologically confirmed diagnosis of any one of the following cancers: urothelial cancer ; melanoma; squamous cell carcinoma of the head and neck; ovarian cancer; NSCLC ; esophageal cancer ; gastric cancer; SS; or MRCLS. Patients must have had measurable disease according to RECIST version 1.1 criteria before LD. Measurable disease was not required before leukapheresis. Patients must have had the following disease-specific requirements for their tumor type .

 

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