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NYESO-1c259 T cells

Phase 1

Ovarian Cancer | Monoclonal antibody | Oncology |Adaptimmune Therapeutics PLC Sponsored ADR|Last Updated: Jun 27, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

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

Phase 1 1
NCT01567891CT Antigen TCR-redirected T Cells for Ovarian Cancer.Ovarian Cancer
COMPLETED9 Analytics
PHASE1COMPLETED
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 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about NYESO-1c259 T cells

What is NYESO-1c259 T cells used for in ovarian cancer?

NYESO-1c259 T cells is an investigational cell therapy being studied for the treatment of ovarian cancer. It is designed to target cancer cells expressing the NY-ESO-1 antigen. The therapy is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does NYESO-1c259 T cells target?

NYESO-1c259 T cells targets the NY-ESO-1 cancer testis antigen, which is expressed on the surface of certain tumor cells. The therapy uses T cells engineered with a T cell receptor that recognizes this antigen, aiming to direct the immune system against cancer cells in ovarian cancer.

Who makes NYESO-1c259 T cells?

NYESO-1c259 T cells is being developed by Adaptimmune Therapeutics PLC, a biopharmaceutical company listed on the stock exchange under the ticker ADAP. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for ovarian cancer.

What phase is NYESO-1c259 T cells in?

NYESO-1c259 T cells is in Phase 1 clinical development. It is an investigational therapy and has not received regulatory approval. A Phase 1 clinical trial has been completed to assess its safety and preliminary activity in patients with ovarian cancer.

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

NYESO-1c259 T cells has been studied in a completed Phase 1 clinical trial with the identifier NCT01567891. The trial, titled 'CT Antigen TCR-redirected T Cells for Ovarian Cancer,' enrolled 9 participants in the United States and evaluated the therapy in patients with ovarian cancer.