- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2023-03-01
2025-05-30
2025-05-30
7
NCT05292859
Alaunos Therapeutics
Alaunos Therapeutics
OBSERVATIONAL
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
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-02-24 | N/A | 2025-07-28 |
2022-03-14 | N/A | 2025-07-30 |
2022-03-23 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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 yea | BIOLOGICAL: Neoantigen specific TCR-T cell drug product
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
