Clinical trial · Observational
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
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
NCT05292859CI-TRIAL-00092806completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Adenosquamous Cell Lung Cancer | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovary Neoplasm | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen specific TCR-T cell drug product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies
- description
- 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.
- interventionNames
- Biological: Neoantigen specific TCR-T cell drug product
Primary outcomes (2)
- 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
- description
- Incidence and duration of new related adverse events
- measure
- To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.