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TerminatedNCT04809766

Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

Phase I Study of Autologous Transgenic T-Cells Expressing High Affinity Mesothelin-Specific T-Cell Receptor (TCR) (FH-TCR Tᴍsʟɴ) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 cohorts. COHORTS I, II and III: LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -5, -4 and -3 or may optionally receive bendamustine IV on days -4 and -3 prior to the 1st T cell infusion. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity. COHORT IV: (Discontinued with amendment 3/28/23) LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up to 15 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAutologous Mesothelin-specific TCR-T CellsReceive FH-TCR Tᴍsʟɴ IV
DRUGCyclophosphamideGiven IV
DRUGFludarabineGiven IV
DRUGBendamustineGiven IV

Timeline

Start date
2021-12-14
Primary completion
2024-10-24
Completion
2025-01-15
First posted
2021-03-22
Last updated
2025-04-20

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04809766. Inclusion in this directory is not an endorsement.