NCT05124743

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous T-Cell Receptor-Engineered T Cells (TCR-T) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: * Gynecologic cancer (ovarian or endometrial) * Colorectal cancer * Pancreatic cancer * Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas * Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.

Detailed description

This protocol will be used to perform and/or collect results from genetic mutation testing (e.g., Oncomine™ or similar genomic test performed at a CLIA-certified laboratory) and high resolution, human leukocyte antigen (HLA) class I and II typing from a CLIA-certified laboratory. This protocol will also collect subject clinical baseline characteristics, demographics, and cancer history. This protocol will be used to monitor subject disease status to identify candidates for enrollment onto the Phase I/II study as patients must have progressive or recurrent disease to be enrolled onto that protocol. The subject's somatic mutation(s) and HLA type restriction combination will be examined against Alaunos' TCR library to determine if a TCR is available for that subject. Subjects without a TCR match will be discontinued from this protocol. If the subject's somatic mutation and HLA type restriction combination matched TCR is added to the Alaunos TCR library after the subject discontinues, the investigator may contact the subject to be re-screened for the study. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, particularly progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Clinical status will be collected at enrollment and approximately every 3 months in conjunction with subjects' regularly scheduled standard of care visits. Subjects with a TCR match will complete participation on this protocol once they enroll in the Phase I/II study or if the subject dies.

Conditions

• Ovarian Cancer
• Endometrial Cancer
• Colo-rectal Cancer
• Cholangiocarcinoma
• Non-small Cell Lung Cancer
• Pancreas Cancer

Timeline

• Start date: 2021-09-24
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2021-11-18
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States