NCT03399448

NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)

Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human trial proposed to test HLA-A\*0201 restricted NY-ESO-1 redirected T cells with edited endogenous T cell receptor and PD-1.

Conditions

• Multiple Myeloma
• Melanoma
• Synovial Sarcoma
• Myxoid/Round Cell Liposarcoma

Interventions

Type	Name	Description
BIOLOGICAL	NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1	Autologous T cells transduced with a lentiviral vector to express NY-ESO-1 and electroporated with CRISPR guide RNA to disrupt expression of endogenous TCRα, TCRβ and PD-1 (NYCE T Cells).
DRUG	Cyclophosphamide	a cytotoxic chemotherapy agent used for lymphodepletion prior to NYCE T cells.
DRUG	Fludarabine	a chemotherapy agent used for lymphodepletion prior to NYCE T cells.
DEVICE	NY-ESO-1 expression testing	Testing to determine if NY-ESO-1 is expressed on tumor tissue.

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-02-29
• Completion: 2020-10-09
• First posted: 2018-01-16
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study