Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies. Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product. |
Biological: Neoantigen specific TCR-T cell drug product
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
|
Outcome Measures
Primary Outcome Measures
- 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
- To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells [Up to 15 years post TCR-T cell drug product infusion]
Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies. Incidence and duration of late onset adverse events Proportion of subjects with adverse events leading to death Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.
Secondary Outcome Measures
- 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
- 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 iRECIST for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
- To continue the clinical efficacy assessment of TCR-T cell product. [Up to 15 years post TCR-T cell drug product infusion]
Duration of response (DoR) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
- To continue the clinical efficacy assessment of TCR-T cell product. [Up to 15 years post TCR-T cell drug product infusion]
Progression-free survival (PFS) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
Other Outcome Measures
- 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.
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
Determine the TCR-T persistence, defined by the duration of TCR-T cell drug product measurable by vector copy number (VCN) in peripheral blood samples
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
Transposon insertion-site clonality in TCR-T cells over time.
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
To evaluate changes in T cell infiltration that may occur within the tumor associated with disease progression following TCR-T cell infusion
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
To evaluate infiltration of TCR-T cells within tumor tissue following disease progression
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
To evaluate the presence of HLA alleles within the tumor associated with disease progression following TCR-T cell infusion
- To evaluate the long-term profile of persisting TCR-T cells. [Up to 15 years post TCR-T cell drug product infusion]
To evaluate changes in the presence of tumor-specific neoantigens within the tumor associated with disease progression following TCR-T cell infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
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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.
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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:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Alaunos Therapeutics
Investigators
- Principal Investigator: Scott Kopetz, MD, PhD, MD Anderson
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TCR001-202