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

Alaunos Therapeutics7 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gynecologic Cancer Colorectal Cancer Pancreatic Cancer Non-small Cell Lung Cancer Cholangiocarcinoma Ovarian Cancer Ovary Neoplasm

Interventions

Neoantigen specific TCR-T cell drug productBIOLOGICAL

No study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells

Incidence and duration of new related adverse events

Time frame: Up to 2 years post TCR-T cell drug product infusion

To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells

* Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies. * Incidence and duration of late onset adverse events * Proportion of subjects with adverse events leading to death * Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.