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NY-ESO-1T Cells

Phase 1

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

NY-ESO-1T Cells target and mechanism

ModalitySmall molecule

Also known as NY-ESO-1(c259)T Cells

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

NY-ESO-1T Cells clinical trials

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?

NY-ESO-1T Cells is an investigational cell therapy being studied in oncology for neoplasms, including synovial sarcoma. It is a genetically engineered T cell product designed to recognize the NY-ESO-1 cancer-testis antigen in patients who are HLA-A2 positive. It is also known as NY-ESO-1(c259)T Cells.

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

NY-ESO-1T Cells is being studied for the treatment of neoplasms, specifically in HLA-A2 positive patients with synovial sarcoma. The clinical program is biomarker-selected, meaning patients are chosen based on HLA-A2 status and NY-ESO-1 expression rather than an unselected population.

Who is developing NY-ESO-1T Cells?

NY-ESO-1T Cells is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical program evaluating this engineered T cell therapy in biomarker-selected cancer patients.

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

NY-ESO-1T Cells is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program has completed, with one trial conducted in the United States enrolling 50 patients.

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

NY-ESO-1T Cells has been evaluated in one Phase 1 trial, NCT01343043, titled a pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1(c259)T in HLA-A2 positive patients with synovial sarcoma. The trial is completed, enrolled 50 patients, was controlled, and included patients aged 4 years and older.

Is NY-ESO-1T Cells the same as NY-ESO-1(c259)T Cells?

Yes, NY-ESO-1T Cells is also known as NY-ESO-1(c259)T Cells. The two names refer to the same genetically engineered T cell therapy developed by GSK plc, so searches under either name point to the same investigational oncology asset.