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NCT04809766 · ClinicalTrials.gov registry record · Phase 1
Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04809766: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT04809766 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04809766, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I trial evaluates the side effects and best dose of mesothelin-specific T-cells (FH-TCR-Tᴍsʟɴ) in treating patients with pancreatic ductal adenocarcinoma that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and may help increase the efficacy from the infused T cells. FH-TCR-Tᴍsʟɴ is an autologous T cell therapy targeting mesothelin, an antigen overexpressed by pancreatic cancer cells. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize mesothelin, a protein on the surface and inside tumor cells. These mesothelin-specific T cells may help the body's immune system identify and kill mesothelin+ tumor cells. Giving chemotherapy with FH-TCR-Tᴍsʟɴ may kill more tumor cells in the treatment of patients with metastatic pancreatic ductal adenocarcinoma.
Primary Outcome
Toxicity (adverse events) will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
- BIOLOGICAL Autologous Mesothelin-specific TCR-T Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2025-01-15 |
| Phase | Phase 1 |
Why NCT04809766 stopped before completion
NCT04809766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04809766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04809766 about?
NCT04809766 is a clinical study titled "Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma". This phase I trial evaluates the side effects and best dose of mesothelin-specific T-cells (FH-TCR-Tᴍsʟɴ) in treating patients with pancreatic ductal adenocarcinoma that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in differe...
What is the current status of trial NCT04809766?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2021-12-14. Estimated completion is 2025-01-15.
What interventions are being tested in trial NCT04809766?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), Autologous Mesothelin-specific TCR-T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04809766?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04809766's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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