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Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors

Colorectal Cancer Clinical Trial

Official title:
Phase I/II Study of Autologous T Cells Engineered Using the Sleeping Beauty System to Express T-Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05194735
Study type Interventional
Source Alaunos Therapeutics
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date April 4, 2022
Completion date November 30, 2024
View Details
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