Clinical trial NCT05292859: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gynecologic Cancer
Colorectal Cancer
Pancreatic Cancer
Non-small Cell Lung Cancer
Cholangiocarcinoma
Ovarian Cancer
Ovary Neoplasm
Squamous Cell Lung Cancer
Adenocarcinoma of Lung
Adenosquamous Cell Lung Cancer
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT05194735 or any protocol in which patients were administered Neoantigen specific TCR-T cell drug product. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post TCR-T cell drug product infusion and will continue to be monitored for safety, immunogenicity and efficacy.

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).

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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: To investigate translational hypotheses related to TCR-T cell persistence.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To determine overall survival.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To continue the clinical efficacy assessment of TCR-T cell product.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To continue the clinical efficacy assessment of TCR-T cell product.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To continue the clinical efficacy assessment of TCR-T cell product.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To continue the clinical efficacy assessment of TCR-T cell product.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
Other outcomes:
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
measure: To evaluate the long-term profile of persisting TCR-T cells.
timeFrame: Up to 15 years post TCR-T cell drug product infusion
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson
name: Scott Kopetz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: