NCT01343043 (NY-ESO-1) is a Phase 1 clinical trial of NY-ESO-1(c259)T Cells in Neoplasms, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01343043?

NCT01343043 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01343043?

Interventions in NCT01343043: NY-ESO-1(c259)T Cells, Fludarabine, Cyclophosphamide.

Is NCT01343043 still recruiting?

NCT01343043 is currently completed. Last updated 30 June 2021.

Are results published for NCT01343043?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-30 · How we verify

NCT01343043: NY-ESO-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma

Completed Phase 1 Results posted Last updated 30 June 2021

What this trial tests

Phase 1 trial testing NY-ESO-1(c259)T Cells in Neoplasms in 50 participants. Completed in 18 June 2019.

Timeline

27 September 2012

Primary endpoint
18 June 2019

18 June 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Primary purpose	treatment
Enrollment	50
Start date	27 September 2012
Primary completion	18 June 2019
Estimated completion	18 June 2019
Sites	8 locations across United States

Drugs / interventions tested

NY-ESO-1(c259)T Cells — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

4 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) Primary · 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.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	50
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	30.8
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	20
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	26.7

Duration of Overall Response Secondary · Up to 4.5 years

Duration of overall response (DOR) is defined as the time from first documented evidence of confirmed CR or confirmed PR until first documented date of disease progression or death due to any cause or surgical resection or start of prohibited medications. Duration of overall response was evaluated per RECIST v1.1. Median and full range of DOR are presented.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	31.0	13 – 72
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	8.6	8 – 13
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	32.1	NA – NA
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	16.4	14 – 94

Progression Free Survival Secondary · Up to 4.5 years

Progression free survival is defined as the interval between the date of first T cell infusion and the earliest documented evidence of disease progression or death due to any cause or surgical resection or start of prohibited medications. Progression free survival was evaluated per RECIST v1.1. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	15.4	8.6 – 37.1
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	13.1	8.3 – 13.9
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	8.6	8.3 – 12.1
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	22.4	11.6 – 38.3

Best Overall Response Secondary · Up to 4.5 years

Best overall response is the best response recorded from the start of treatment (first T cell infusion) until disease progression/recurrence. Response categories from best to worst are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed. Data for number of participants with CR, PR, SD and PD are presented.

Complete response

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	1
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	0
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	0
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	0

Partial response

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	5
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	4
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	1
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	4

Stable disease

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	5
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	7
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	3
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	10

Progressive disease

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	1
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	1
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	0
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	1

Not evaluable

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	0
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	1
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	1
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	0

Overall Survival Secondary · Up to 4.5 years

Overall survival is defined as the interval between the date of the first T-cell infusion and date of death from any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	80.7	45.3 – 212.0
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	43.1	19.4 – 85.3
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	86.4	68.1 – 104.6
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	105.3	50.3 – NA

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Secondary · Up to 5 years

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had non-SAEs and SAEs are pr

Non-SAE

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	15
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	13
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	5
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	15

SAE

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	9
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	7
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	4
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	6

Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result Secondary · Up to 4.5 years

Serum samples were collected for the determination of anti-infused (NY-ESO-1 genetically engineered T) cell antibodies (ATA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. A participant was considered to have a confirmed positive ATA result if they have a positive screening assay result and a positive confirmation assay result.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	0
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	0
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	0
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	0

Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells Secondary · Up to 4.5 years

Time to maximum persistence is defined as date of maximum persistence for infusion visit minus date of first T cell infusion visit plus 1. Median and full range of time to maximum persistence are presented.

Group	Value	95% CI
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	8.0	4 – 29
Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	8.0	5 – 18
Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	8.0	8 – 8
Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	9	6 – 13

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment (Day 1) until maximum of 4.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: High NY-ESO-1 Expression Treated With Regimen A

Serious: 9/15 (60%)

Deaths: 12/15

Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A

Serious: 7/14 (50%)

Deaths: 13/14

Cohort 3: High NY-ESO-1 Expression Treated With Regimen B

Serious: 4/5 (80%)

Deaths: 4/5

Cohort 4: High NY-ESO-1 Expression Treated With Regimen C

Serious: 6/16 (38%)

Deaths: 8/16

Serious adverse events (49 terms)

Reaction	System	Cohort 1: High NY-ESO-1 Ex…	Cohort 2: Low NY-ESO-1 Exp…	Cohort 3: High NY-ESO-1 Ex…	Cohort 4: High NY-ESO-1 Ex…
Pyrexia	General disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Embolism	Vascular disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Guillain-Barre syndrome	Nervous system disorders	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Bone marrow failure	Blood and lymphatic system disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—

Other adverse events (315 terms — click to expand)

Reaction	System	Cohort 1: High NY-ESO-1 Ex…	Cohort 2: Low NY-ESO-1 Exp…	Cohort 3: High NY-ESO-1 Ex…	Cohort 4: High NY-ESO-1 Ex…
Fatigue	General disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Lipase increased	Investigations	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Pyrexia, Hypotension, Cytokine release syndrome, Dyspnoea, Pneumothorax, Chills, Febrile neutropenia, Embolism.

Data from ClinicalTrials.gov NCT01343043 adverse events section.

Sponsor's own description

The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antitumor Activity Associated with Prolonged Persistence of Adoptively Transferred NY-ESO-1 <sup>c259</sup>T Cells in Synovial Sarcoma.
D'Angelo SP, Melchiori L, Merchant MS, Bernstein D, et al · · 2018 · cited 357× · PMID 29891538 · DOI 10.1158/2159-8290.cd-17-1417
NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
TCR-engineered T cell therapy in solid tumors: State of the art and perspectives.
Baulu E, Gardet C, Chuvin N, Depil S. · · 2023 · cited 283× · PMID 36791198 · DOI 10.1126/sciadv.adf3700
T-cell infiltration and clonality correlate with programmed cell death protein 1 and programmed death-ligand 1 expression in patients with soft tissue sarcomas.
Pollack SM, He Q, Yearley JH, Emerson R, et al · · 2017 · cited 213× · PMID 28463396 · DOI 10.1002/cncr.30726
Cancer Therapy With TCR-Engineered T Cells: Current Strategies, Challenges, and Prospects.
Shafer P, Kelly LM, Hoyos V. · · 2022 · cited 181× · PMID 35309357 · DOI 10.3389/fimmu.2022.835762
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6
Systemic and local immunity following adoptive transfer of NY-ESO-1 SPEAR T cells in synovial sarcoma.
Ramachandran I, Lowther DE, Dryer-Minnerly R, Wang R, et al · · 2019 · cited 127× · PMID 31651363 · DOI 10.1186/s40425-019-0762-2
Epidemiology and therapies for metastatic sarcoma.
Amankwah EK, Conley AP, Reed DR. · · 2013 · cited 126× · PMID 23700373 · DOI 10.2147/clep.s28390

Verify or expand the search:

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01343043 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 30 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01343043.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing