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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Sandra Sinclair, MHA/Ed,RN; Phone Number: 832-622-1699; Email: ssinclair@alaunos.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Kim Ross; Email: GIClinicalTrials@mdanderson.org
      • Principal Investigator: Scott Kopetz, MD, PhD
      • Sub-Investigator: Marcelo Negrao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT05194735 or any protocol in which patients were administered Neoantigen specific TCR-T cell drug product. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post TCR-T cell drug product infusion and will continue to be monitored for safety, immunogenicity and efficacy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the long-term profile of persisting TCR-T cells.	Primary and secondary malignancy: presence of TCR-T cells in tumor samples biopsy and autopsy.	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	Determine the TCR-T persistence, defined by the duration of TCR-T cell drug product measurable by vector copy number (VCN) in peripheral blood samples	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	Transposon insertion-site clonality in TCR-T cells over time.	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	To evaluate changes in T cell infiltration that may occur within the tumor associated with disease progression following TCR-T cell infusion	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	To evaluate infiltration of TCR-T cells within tumor tissue following disease progression	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	To evaluate the presence of HLA alleles within the tumor associated with disease progression following TCR-T cell infusion	Up to 15 years post TCR-T cell drug product infusion
To evaluate the long-term profile of persisting TCR-T cells.	To evaluate changes in the presence of tumor-specific neoantigens within the tumor associated with disease progression following TCR-T cell infusion	Up to 15 years post TCR-T cell drug product infusion

Collaborators and Investigators

• Sponsor: Alaunos Therapeutics
• Investigators: Principal Investigator: Scott Kopetz, MD, PhD, MD Anderson

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): April 1, 2039
• Study Completion (Anticipated): June 1, 2039

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Cholangiocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: TCR001-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No