Patients
melanoma, head and neck squamous cell carcinoma, tumour, TCRs, non-small cell lung carcinoma
OVARIAN CANCER, SOLID TUMOUR, COLORECTAL CANCER, DISEASE PROGRESSION, MELANOMA, BRAIN METASTASIS, BREAST CANCER, UROTHELIAL CARCINOMA, NON-SMALL CELL LUNG CARCINOMA, TRIPLE-NEGATIVE BREAST CANCER, DISEASE, TUMOUR, ONCOLOGY, PROSTATE CANCER
Patients were eligible for screening to identify TCRs if they met the following criteria: were ≥18 years of age; had one of the following metastatic solid tumour types: urothelial carcinoma, melanoma, non-small cell lung carcinoma, head and neck squamous cell carcinoma, colorectal cancer, ovarian cancer, hormone-receptor positive breast cancer, triple-negative breast cancer, or prostate cancer; had disease progression after at least one available standard therapy with no additional curative options available; and measurable disease per response evaluation criteria in solid tumours (RECIST) v.1.1. Inclusion criteria for TCR identification included providing a tumour biopsy (fresh or archival tumour biopsy within 1 year of consent) for sequencing and neoantigen prediction, PBMCs for T cell isolation and a willingness and ability to undergo leukapheresis for cell product manufacture. To decrease the risk of decline during TCR product selection and cell therapy manufacture and infusion, patients were required to have a life expectancy of >6 months, an Eastern Cooperative Oncology Group status of 0 or 1 and adequate haematological and organ function.Between consent and neoTCR product selection, patients were able to be treated with anticancer therapies. Patients were required to discontinue therapy within 2 weeks or five half-lives (whichever was shorter) before leukapheresis. Following successful neoTCR product selection and before leukapheresis, patients were required to meet the initial screening criteria with adequate haematological and organ function. Patients with asymptomatic brain metastasis were included. Eligible patients had an absolute lymphocyte count of at least 500 cells per cubic millimetre. During cell product manufacture, patients could receive bridging therapy at the investigator’s discretion, after which repeat baseline imaging was performed. Before receiving conditioning chemotherapy and cell infusion, patients were required to have no significant changes in status compared with the initial eligibility criteria.