Trial · NCT01343043
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
NCT01343043, Phase 1, Completed, GlaxoSmithKline; results first posted 2020-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma. Trials, record NCT01343043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01343043
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
- NCT number
- NCT01343043
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
- NY-ESO-1(c259)T Cells, Fludarabine, Cyclophosphamide
- First posted
- 2011-04-27
- Last updated
- 2021-06-30
- Other registries' IDs
- eudract:2015-005594-21
- Results first posted
- 2020-07-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Duration of Overall Response | 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. |
| Secondary | Progression Free Survival | 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. |
| Secondary | Best Overall Response | 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. |
| Secondary | Overall Survival | 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. |
| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | 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 presented. |
| Secondary | Number of Participants With Worst Post-Baseline Grade Results for Hematology Parameters | Up to 4.5 years | Blood samples were collected for the analysis of hematology parameters. No data collected separately for this outcome measure as any abnormal value would be recorded as an adverse event. |
| Secondary | Number of Participants With Worst Post-Baseline Grade Results for Clinical Chemistry Parameters | Up to 4.5 years | Blood samples were collected for the analysis of clinical chemistry parameters. No data collected separately for this outcome measure as any abnormal value would be recorded as an adverse event. |
| Secondary | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result | 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. |
| Secondary | Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | Up to Week 4 | CRS is a potentially life-threatening toxicity that is observed following administration of antibodies and adoptive T-cell therapies for cancer. Serum samples were collected to analyze the concentration of cytokines using the electrochemiluminescent tagged detection antibodies. The correlation between cytokines and cytokine release syndrome was considered between participants who had serious CRS vs no CRS or Non-serious CRS. There were only 4 participants across the whole study that had serious CRS and cytokine data was available for 3 of these participants. Due to the limited number of participants that had serious CRS no statistical correlations in cytokine levels and CRS could be performed. A listing of the levels of cytokines for the 3 participants with serious CRS is available/provided. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to 4.5 years | Modified intent-to-treat (mITT) Population comprised of all participants who received NY-ESO-1 genetically engineered T cell infusion | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Overall Response | Up to 4.5 years | mITT Population. Only those participants with data available at the specified data points were analyzed. | Weeks | MEDIAN |
| SECONDARY | Progression Free Survival | Up to 4.5 years | mITT Population | Weeks | MEDIAN |
| SECONDARY | Best Overall Response | Up to 4.5 years | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 4.5 years | mITT Population | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to 5 years | Intent-to-treat (ITT) Population comprised of all participants who were enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Post-Baseline Grade Results for Hematology Parameters | Up to 4.5 years | mITT Population | ||
| SECONDARY | Number of Participants With Worst Post-Baseline Grade Results for Clinical Chemistry Parameters | Up to 4.5 years | mITT Population | ||
| SECONDARY | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result | Up to 4.5 years | mITT Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | Up to Week 4 | mITT Population. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 50 | Percentage of Participants | ||
| Objective Response Rate (ORR) | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 30.8 | Percentage of Participants | ||
| Objective Response Rate (ORR) | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 20 | Percentage of Participants | ||
| Objective Response Rate (ORR) | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 26.7 | Percentage of Participants | ||
| Duration of Overall Response | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 31.0 | Full Range 13 to 72 | Weeks | |
| Duration of Overall Response | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 8.6 | Full Range 8 to 13 | Weeks | |
| Duration of Overall Response | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 32.1 | Full Range NA to NA | Weeks | |
| Duration of Overall Response | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 16.4 | Full Range 14 to 94 | Weeks | |
| Progression Free Survival | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 15.4 | Inter-Quartile Range 8.6 to 37.1 | Weeks | |
| Progression Free Survival | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13.1 | Inter-Quartile Range 8.3 to 13.9 | Weeks |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 15 | |
| Overall Study | STARTED | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 14 | |
| Overall Study | STARTED | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 5 | |
| Overall Study | STARTED | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 16 | |
| Overall Study | Received T-cell Infusion | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 12 | |
| Overall Study | Received T-cell Infusion | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13 | |
| Overall Study | Received T-cell Infusion | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 5 | |
| Overall Study | Received T-cell Infusion | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 15 | |
| Overall Study | COMPLETED | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 12 | |
| Overall Study | COMPLETED | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,456
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 12 | 15 | |
| other | Fatigue | General disorders | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 8 | 14 | |
| other | Fatigue | General disorders | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 3 | 5 | |
| other | Fatigue | General disorders | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 14 | 16 | |
| other | Pyrexia | General disorders | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 12 | 15 | |
| other | Pyrexia | General disorders | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 10 | 14 | |
| other | Pyrexia | General disorders | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 4 | 5 | |
| other | Pyrexia | General disorders | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 9 | 16 | |
| other | Oedema peripheral | General disorders | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 4 | 15 | |
| other | Oedema peripheral | General disorders | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 5 | 14 |
1 to 10 of 1,456Source ClinicalTrials.gov
See all 1,456 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 12 | 15 |
| Total, all-cause mortality | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13 | 14 |
| Total, all-cause mortality | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 4 | 5 |
| Total, all-cause mortality | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 8 | 16 |
| Total, other adverse events | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 15 | 15 |
| Total, other adverse events | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13 | 14 |
| Total, other adverse events | Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 5 | 5 |
| Total, other adverse events | Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 15 | 16 |
| Total, serious adverse events | Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 9 | 15 |
| Total, serious adverse events | Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 7 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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