Ovarian Cancer Clinical Trial

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

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

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Full 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).

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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:

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.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

180

Study ID:

NCT05292859

Recruitment Status:

Recruiting

Sponsor:

Alaunos Therapeutics

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There is 1 Location for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Kim Ross
Contact
[email protected]
Scott Kopetz, MD, PhD
Principal Investigator
Marcelo Negrao, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

180

Study ID:

NCT05292859

Recruitment Status:

Recruiting

Sponsor:


Alaunos Therapeutics

How clear is this clinincal trial information?

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