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

Active, not recruiting

• Conditions: Colorectal Cancer; Pancreatic Cancer; Non-small Cell Lung Cancer; Ovarian Cancer; Adenocarcinoma of Lung; Adenosquamous Cell Lung Cancer; Ovary Neoplasm; Cholangiocarcinoma; Gynecologic Cancer; Squamous Cell Lung Cancer
• Interventions: Biological: Neoantigen specific TCR-T cell drug product

• Registration Number: NCT05292859
• Lead Sponsor: Alaunos Therapeutics

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Study Start: 2022-10-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29
• Primary Completion: 2039-04
• Study Completion: 2039-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies	Neoantigen specific TCR-T cell drug product	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.

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells	Up to 15 years post TCR-T cell drug product infusion	* 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.

Secondary Outcome Measures

Name	Time	Method
To investigate translational hypotheses related to TCR-T cell persistence.	Up to 15 years post TCR-T cell drug product infusion	Duration of TCR-T cell drug product persistence by vector copy number (VCN).
To determine overall survival.	Up to 15 years post TCR-T cell drug product infusion	Date of TCR-T cell drug product administration to death
To continue the clinical efficacy assessment of TCR-T cell product.	Up to 15 years post TCR-T cell drug product infusion	Progression-free survival (PFS) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States