Status:
COMPLETED
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Gynecologic Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
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-spe...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05292859
Start Date
March 1 2023
End Date
May 30 2025
Last Update
July 30 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030