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NCT Number: NCT05292859

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 Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors

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Key information

Conditions

Gynecologic Cancer Adenocarcinoma Adenocarcinoma of Lung Adenosquamous Cell Lung Cancer Adnexal Diseases Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Ovary Neoplasm Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Lung Cancer Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

Primary outcomes

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

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

    Incidence and duration of new related adverse events

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

    Time frame: 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 outcomes

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

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

    Duration of TCR-T cell drug product persistence by vector copy number (VCN).

  2. To determine overall survival.

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

    Date of TCR-T cell drug product administration to death

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

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

    Overall response by RECIST 1.1 for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies

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

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

    Overall response by iRECIST for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies

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

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

    Duration of response (DoR) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies

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

    Time frame: 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

Other outcomes

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

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

    Primary and secondary malignancy: presence of TCR-T cells in tumor samples biopsy and autopsy.

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

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

    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

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

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

    Transposon insertion-site clonality in TCR-T cells over time.

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

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

    To evaluate changes in T cell infiltration that may occur within the tumor associated with disease progression following TCR-T cell infusion

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

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

    To evaluate infiltration of TCR-T cells within tumor tissue following disease progression

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

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

    To evaluate the presence of HLA alleles within the tumor associated with disease progression following TCR-T cell infusion

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

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

    To evaluate changes in the presence of tumor-specific neoantigens within the tumor associated with disease progression following TCR-T cell infusion

Sponsors and collaborators

Lead sponsor

Alaunos Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2022
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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