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

NCT05292859 | Completed FDA Drug

• 1 other identifier: TCR001-202
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• To investigate translational hypotheses related to TCR-T cell persistence.

  Up to 15 years post TCR-T cell drug product infusion

• To determine overall survival.

  Up to 15 years post TCR-T cell drug product infusion

• To continue the clinical efficacy assessment of TCR-T cell product.

  Up to 15 years post TCR-T cell drug product infusion

• To continue the clinical efficacy assessment of TCR-T cell product.

  Up to 15 years post TCR-T cell drug product infusion

• To continue the clinical efficacy assessment of TCR-T cell product.

  Up to 15 years post TCR-T cell drug product infusion

Other Outcomes (7)

• To evaluate the long-term profile of persisting TCR-T cells.

  Up to 15 years post TCR-T cell drug product infusion

• To evaluate the long-term profile of persisting TCR-T cells.

  Up to 15 years post TCR-T cell drug product infusion

• To evaluate the long-term profile of persisting TCR-T cells.

  Up to 15 years post TCR-T cell drug product infusion

Study Arms (1)

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

Interventions

Neoantigen specific TCR-T cell drug product BIOLOGICAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected for the analysis of TCR-T cell drug product persistence by vector copy number (VCN). The collection of tumor tissue samples is to enable the investigation of changes that may occur within the tumor associated with progression. Tissue samples will be analyzed by NGS (e.g., WES, RNA-Seq, etc.) to evaluate T cell infiltration, TCR-T cell drug product infiltration, presence of HLA alleles and presence of tumor-specific neoantigens. Additional confirmatory analyses of these samples (e.g., immunohistochemistry (IHC) or in situ hybridization (ISH)to verify target expression) may be performed based on emergent data and sufficient sample availability.

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Cholangiocarcinoma; Ovarian Neoplasms; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

Study Officials

• Scott Kopetz, MD, PhD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 23, 2022
• Study Start: March 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)