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NY-ESO-1T Cells

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Jun 30, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

NY-ESO-1T Cells · 1 trial · 1 indication

Phase 1 1
NCT01343043A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial SarcomaNeoplasms
COMPLETED50 Analytics
PHASE1COMPLETED
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
Up to 4.5 years

ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by the local investigators.

Secondary Endpoints

Duration of Overall Response
Up to 4.5 years
Progression Free Survival
Up to 4.5 years
Best Overall Response
Up to 4.5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 treated with NY-ESO-1 T CellsEXPERIMENTALHigh NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy.
Cohort 2 treated with NY-ESO-1 T CellsEXPERIMENTALLow NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy.
Cohort 3 treated with NY-ESO-1 T CellsEXPERIMENTALHigh NYESO-1 expression and the use of cyclophosphamide only for lymphodepletion rather than fludarabine as the lymphodepleting chemotherapy.
Cohort 4 treated with NY-ESO-1 T CellsEXPERIMENTALHigh NY-ESO-1 expression and the use of reduced dose cyclophosphamide plus fludarabine regimen as the lymphodepleting chemotherapy.

Interventions

NameTypeDescription
NY-ESO-1(c259)T CellsDRUGLymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.
FludarabineDRUGFludarabine will be used as lymphodepleting chemotherapy.
CyclophosphamideDRUGCyclophosphamide will be used as lymphodepleting chemotherapy.
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Eligibility Criteria

Age Range4 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Synovial sarcoma that has been treated with standard chemotherapy containing ifosfamide and/or doxorubicin and remains: unresectable or metastatic or progressive/persistent or recurrent disease * Measurable disease * Patients must have proven positive tumor sample for NY-ESO-1...

Countries:United States
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Frequently asked questions about NY-ESO-1T Cells

What is NY-ESO-1T Cells used for?

NY-ESO-1T Cells is an investigational cell therapy being studied for the treatment of neoplasms, specifically in patients with synovial sarcoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing NY-ESO-1T Cells?

NY-ESO-1T Cells is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK.

What phase is NY-ESO-1T Cells in?

NY-ESO-1T Cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved for commercial use and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is NY-ESO-1T Cells in?

NY-ESO-1T Cells has been studied in one completed clinical trial, identified as NCT01343043. This was a pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1ᶜ²⁵⁹T cells in HLA-A2+ patients with synovial sarcoma, conducted in the United States with 50 participants.

Is NY-ESO-1T Cells the same as NY-ESO-1ᶜ²⁵⁹T?

Yes, NY-ESO-1T Cells is also known as NY-ESO-1ᶜ²⁵⁹T. The clinical trial NCT01343043 refers to the therapy as genetically engineered NY-ESO-1 specific NY-ESO-1ᶜ²⁵⁹T cells.