Brief Title
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Official 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
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).
Study Type
Observational
Primary Outcome
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
Secondary Outcome
To investigate translational hypotheses related to TCR-T cell persistence.
Condition
Gynecologic Cancer
Intervention
Neoantigen specific TCR-T cell drug product
Study Arms / Comparison Groups
Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
180
Start Date
October 1, 2022
Completion Date
June 2039
Primary Completion Date
April 2039
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Scott Kopetz, MD, PhD, 832-622-1699, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05292859
Organization ID
TCR001-202
Responsible Party
Sponsor
Study Sponsor
Alaunos Therapeutics
Study Sponsor
Scott Kopetz, MD, PhD, Principal Investigator, MD Anderson
Verification Date
March 2023