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
Overview
- Phase
- Not Applicable
- Intervention
- Neoantigen specific TCR-T cell drug product
- Conditions
- Gynecologic Cancer
- Sponsor
- Alaunos Therapeutics
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Neoantigen specific TCR-T cell drug product
Outcomes
Primary Outcomes
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
- 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)