Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

Alaunos Therapeutics

Status: Completed

Conditions: Squamous Cell Lung Cancer; Non-small Cell Lung Cancer; Gynecologic Cancer; Cholangiocarcinoma; Adenocarcinoma of Lung; Ovarian Cancer; Adenosquamous Cell Lung Cancer; Ovary Neoplasm; Pancreatic Cancer; Colorectal Cancer

Treatments: Biological: Neoantigen specific TCR-T cell drug product

Study type: Observational

Funder types: Industry

Identifiers

NCT05292859

TCR001-202

Details and patient eligibility

About

Long-Term Follow-Up Study for Subjects Enrolled in the 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

Full description

This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.
2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
3. Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
4. Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.

Exclusion criteria

1. Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.

Trial design

7 participants in 1 patient group

Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies

Description:

This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies. Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product.

Treatment:

Biological: Neoantigen specific TCR-T cell drug product