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NYESO-1c259 T cells

Phase 1/2

Ovarian Cancer | Biologics | Oncology |Adaptimmune Therapeutics PLC|Trials Updated: Jun 27, 2019

NYESO-1c259 T cells development status

Highest phase Phase 1/2
Registered trials 1 across 1 sponsor since Mar 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

NYESO-1c259 T cells clinical trials

NYESO-1c259 T cells · 1 trial · 1 indication

Phase 1/2 1
NCT01567891CT Antigen TCR-redirected T Cells for Ovarian Cancer.Ovarian Cancer
COMPLETED9 Analytics
PHASE1/PHASE2COMPLETED
CT Antigen TCR-redirected T Cells for Ovarian Cancer.
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events Related to Study Treatment
Up to 12 months

Number of Participants with Adverse Events related to study treatment

Secondary Endpoints

Tumor Response
Change from baseline, every 4 weeks until month 3 and then every 3 month until disease progression
Peak Persistence of Modified T-cells in the Peripheral Blood
Days: 1, 2-4, weeks 1 to 4, Week 8, 12 and Month 6, then every 3 months thereafter until progression then during LTFU
Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.
Weeks 4 and 8 post T-cell infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALThis is an open label clinical trial. Patients with the HLA-A201, HLA-A205, and/or HLA-A206 allele and whose tumor expresses the NY-ESO-1 tumor antigen will be eligible to receive NYESO-1c259 T cells.

Interventions

NameTypeDescription
NYESO-1c259 T cellsBIOLOGICALCytoreductive chemotherapy followed by infusion with NYESO-1(C259) transduced autologous T cells. Patients will receive at least 1x10⁹ transduced cells, however the target dose for this protocol is for patients to receive 5x10⁹ transduced cells with a maximum possible dose of 6x10⁹ administered as a single intravenous (IV) infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Must have a diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube carcinoma with refractory or platinum resistant disease and/or have received ≥ 2 lines of chemotherapy * Age ≥ 18 years of age * No significant immunodeficiency * Have been informed of ...

Countries:United States
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Competitive Landscape -Ovarian Cancer 243 trials

Frequently asked questions about NYESO-1c259 T cells

What is NYESO-1c259 T cells?

NYESO-1c259 T cells are an investigational cell therapy being studied in ovarian cancer. They are a biologic product developed by Adaptimmune Therapeutics PLC. The program has been evaluated in a single Phase 1/2 clinical trial conducted in the United States that enrolled 9 participants and is now completed.

What is NYESO-1c259 T cells used for?

NYESO-1c259 T cells have been studied for the treatment of ovarian cancer. The clinical work in this program focused on patients with ovarian cancer, with trial participants aged 18 years and older. The therapy remains investigational and is not an approved treatment for ovarian cancer or any other indication.

Who is developing NYESO-1c259 T cells?

NYESO-1c259 T cells are being developed by Adaptimmune Therapeutics PLC, which trades under the ticker ADAPY. The company is the sponsor behind the ovarian cancer cell therapy program, which has completed one Phase 1/2 clinical trial in the United States.

What phase is NYESO-1c259 T cells in?

NYESO-1c259 T cells are in Phase 1/2 development. The program's single clinical trial, NCT01567891, was a Phase 1/Phase 2 study in ovarian cancer that has been completed. NYESO-1c259 T cells are investigational and are not FDA approved.

What clinical trials is NYESO-1c259 T cells in?

NYESO-1c259 T cells have been evaluated in one clinical trial, NCT01567891, titled CT Antigen TCR-redirected T Cells for Ovarian Cancer. The Phase 1/Phase 2 study was conducted in the United States, enrolled 9 participants, used an uncontrolled design, and is completed.