CompletedNot Applicable

Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

United States7 participantsStarted 2023-03-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT05292859

SponsorAlaunos Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-30

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