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

NCT03399448 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-06-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Edward Stadtmauer, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-02-29
Completion
2020-10-09
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03399448 on ClinicalTrials.gov