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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

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

Intervention / Treatment
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* Biological: Neoantigen specific TCR-T cell drug product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies<br>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. | Biological: Neoantigen specific TCR-T cell drug product<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells | Incidence and duration of new related adverse events | 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. | Up to 15 years post TCR-T cell drug product infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate translational hypotheses related to TCR-T cell persistence. | Duration of TCR-T cell drug product persistence by vector copy number (VCN). | Up to 15 years post TCR-T cell drug product infusion | 
| To determine overall survival. | Date of TCR-T cell drug product administration to death | Up to 15 years post TCR-T cell drug product infusion | 
| To continue the clinical efficacy assessment of TCR-T cell product. | Overall response by RECIST 1.1 for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion | 
| To continue the clinical efficacy assessment of TCR-T cell product. | Overall response by iRECIST for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion | 
| To continue the clinical efficacy assessment of TCR-T cell product. | Duration of response (DoR) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion | 
| To continue the clinical efficacy assessment of TCR-T cell product. | Progression-free survival (PFS) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion |