A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors.~An HLA Typing and Tumor Neoantigen Mutation Testing Protocol (Protocol # TCR001-002) has been used to identify patients for potential enrollment into this Study Protocol. Subjects who have completed the HLA Typing and Tumor Neoantigen Mutation Testing Protocol, i.e., subjects for whom a TCR matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' TCR library will be eligible for enrollment on this study.~The Phase I part of this study is a prospective, open-label, dose-escalation study of TCR-T cell drug product in patients with progressive or recurrent solid tumors who have failed standard therapy. The Phase II part is a prospective, open-label, single dose portion of the study. The Phase II part will begin once the MTD/RP2D in the Phase I part has been determined.~Subjects with one of the following histologically confirmed solid tumors will be included:~Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)~Cohort 2: Colorectal cancer~Cohort 3: Pancreatic cancer~Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas~Cohort 5: Cholangiocarcinoma~Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation & HLA type):~KRAS G12D & HLA-A*11:01~KRAS G12D & HLA-C*08:02~KRAS G12V & HLA-A*11:01~KRAS G12V & HLA-C*01:02~TP53 R175H & HLA-A*02:01~TP53 R175H & HLA-DRB1*13:01~TP53 R248W & HLA-A*68:01~TP53 Y220C & HLA-A*02:01~TP53 Y220C & HLA-DRB3*02:02~EGFR E746-A750del & HLA-DPA1*02:01, DPB1*01:01
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors