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
Conditions
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).
Interventions
No study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy
Sponsors
Alaunos Therapeutics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells | Up to 2 years post TCR-T cell drug product infusion | Incidence and duration of new related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate translational hypotheses related to TCR-T cell persistence. | Up to 15 years post TCR-T cell drug product infusion | Duration of TCR-T cell drug product persistence by vector copy number (VCN). |
| To determine overall survival. | Up to 15 years post TCR-T cell drug product infusion | Date of TCR-T cell drug product administration to death |
| To continue the clinical efficacy assessment of TCR-T cell product. | Up to 15 years post TCR-T cell drug product infusion | Overall response by RECIST 1.1 for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the long-term profile of persisting TCR-T cells. | Up to 15 years post TCR-T cell drug product infusion | Primary and secondary malignancy: presence of TCR-T cells in tumor samples biopsy and autopsy. |
Countries
United States
Outcome results
None listed