NCT05194735

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Gynecologic Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Non-small Cell Lung Cancer
• Cholangiocarcinoma
• Ovarian Cancer
• Endometrial Cancer
• Ovarian Carcinoma
• Ovary Neoplasm
• Squamous Cell Lung Cancer
• Adenocarcinoma of Lung
• Adenosquamous Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Neoantigen specific TCR-T cell drug product	Phase I: Ascending dose, single Infusion of TCR+ Cells Phase II: Single infusion at the RP2D
BIOLOGICAL	Aldesleukin (IL-2)	To support growth and activation of TCR-T cell drug product

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2022-01-18
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study