Trial · NCT02992743
Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma
NCT02992743, Phase 2, Completed, GlaxoSmithKline; results first posted 2022-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma. Trials, record NCT02992743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02992743
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma
- NCT number
- NCT02992743
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
- letetresgene autoleucel (GSK3377794), Cyclophosphamide, Fludarabine
- First posted
- 2016-12-14
- Last updated
- 2023-04-11
- Results first posted
- 2022-11-28
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Up to 24 months | Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. |
| Primary | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Up to 24 months | The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response \[CR\] \> Confirmed Partial Response \[PR\] \> Stable Disease \[SD\] \> Progressive Disease \[PD\] \> Not Evaluable \[NE\]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria. |
| Secondary | Time to Response (TTR) Assessed by Investigator | Up to 24 months | Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. |
| Secondary | Duration of Response (DOR) Assessed by Investigator | Up to 24 months | Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. |
| Secondary | Progression Free Survival (PFS) Assessed by Investigator | Up to 24 months | Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. |
| Secondary | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment | Up to 24 months | The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response \[CR\] \> Confirmed Partial Response \[PR\] \> Stable Disease \[SD\] \> Progressive Disease \[PD\] \> Not Evaluable \[NE\]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria. |
| Secondary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer | Up to 24 months | Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. |
| Secondary | Time to Response (TTR) Assessed by Independent Reviewer | Up to 24 months | Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. |
| Secondary | Duration of Response (DOR) Assessed by Independent Reviewer | Up to 24 months | Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. |
| Secondary | Progression Free Survival (PFS) Assessed by Independent Reviewer | Up to 24 months | Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Up to 24 months | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Percentage of participants | NUMBER |
| PRIMARY | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Up to 24 months | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) Assessed by Investigator | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Assessed by Investigator | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Assessed by Investigator | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment | Up to 24 months | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer | Up to 24 months | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) Assessed by Independent Reviewer | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Assessed by Independent Reviewer | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Assessed by Independent Reviewer | Up to 24 months | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Months | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Reduced Lymphodepletion Dose Plus GSK3377794 | 20 | 95% Confidence Interval 2.5 to 55.6 | Percentage of participants | |
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Standard Lymphodepletion Dose Plus GSK3377794 | 40 | 95% Confidence Interval 12.2 to 73.8 | Percentage of participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Reduced Lymphodepletion Dose Plus GSK3377794 | Complete Response (CR) | 0 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Standard Lymphodepletion Dose Plus GSK3377794 | Complete Response (CR) | 0 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Reduced Lymphodepletion Dose Plus GSK3377794 | Partial Response (PR) | 2 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Standard Lymphodepletion Dose Plus GSK3377794 | Partial Response (PR) | 4 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Reduced Lymphodepletion Dose Plus GSK3377794 | Stable Disease (SD) | 8 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Standard Lymphodepletion Dose Plus GSK3377794 | Stable Disease (SD) | 5 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Reduced Lymphodepletion Dose Plus GSK3377794 | Progressive Disease (PD) | 0 | Participants | |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | Standard Lymphodepletion Dose Plus GSK3377794 | Progressive Disease (PD) | 1 | Participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Reduced Lymphodepletion Dose Plus GSK3377794 | 13 | |
| Overall Study | STARTED | Standard Lymphodepletion Dose Plus GSK3377794 | 10 | |
| Overall Study | Received T-cell Infusion | Reduced Lymphodepletion Dose Plus GSK3377794 | 10 | |
| Overall Study | Received T-cell Infusion | Standard Lymphodepletion Dose Plus GSK3377794 | 10 | |
| Overall Study | COMPLETED | Reduced Lymphodepletion Dose Plus GSK3377794 | 9 | |
| Overall Study | COMPLETED | Standard Lymphodepletion Dose Plus GSK3377794 | 8 | |
| Overall Study | NOT COMPLETED | Reduced Lymphodepletion Dose Plus GSK3377794 | 4 | |
| Overall Study | NOT COMPLETED | Standard Lymphodepletion Dose Plus GSK3377794 | 2 |
Source ClinicalTrials.gov
Adverse events386
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 | Anaemia | Blood and lymphatic system disorders | Reduced Lymphodepletion Dose Plus GSK3377794 | 6 | 13 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Standard Lymphodepletion Dose Plus GSK3377794 | 9 | 10 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Reduced Lymphodepletion Dose Plus GSK3377794 | 2 | 13 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Standard Lymphodepletion Dose Plus GSK3377794 | 4 | 10 | 4 |
| other | Leukocytosis | Blood and lymphatic system disorders | Reduced Lymphodepletion Dose Plus GSK3377794 | 2 | 13 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 10 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Reduced Lymphodepletion Dose Plus GSK3377794 | 2 | 13 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 10 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Reduced Lymphodepletion Dose Plus GSK3377794 | 1 | 13 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 10 | 0 |
1 to 10 of 386Source ClinicalTrials.gov
See all 386 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reduced Lymphodepletion Dose Plus GSK3377794 | 5 | 13 |
| Total, all-cause mortality | Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 10 |
| Total, other adverse events | Reduced Lymphodepletion Dose Plus GSK3377794 | 13 | 13 |
| Total, other adverse events | Standard Lymphodepletion Dose Plus GSK3377794 | 10 | 10 |
| Total, serious adverse events | Reduced Lymphodepletion Dose Plus GSK3377794 | 5 | 13 |
| Total, serious adverse events | Standard Lymphodepletion Dose Plus GSK3377794 | 7 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39836945 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 vs Standard Lymphodepletion Dose Plus GSK3377794: Number of Participants With Insertional Oncogenesis | Trial comparisons |
| Reduced Lymphodepletion Dose Plus GSK3377794 vs Standard Lymphodepletion Dose Plus GSK3377794: Number of Participants With Replication Competent Lentivirus (RCL) | Trial comparisons |
| Reduced Lymphodepletion Dose Plus GSK3377794 vs Standard Lymphodepletion Dose Plus GSK3377794: deaths from any cause | Trial comparisons |
| Reduced Lymphodepletion Dose Plus GSK3377794 vs Standard Lymphodepletion Dose Plus GSK3377794: Number of Participants With Positive Anti-drug Antibodies (ADAs) | Trial comparisons |
| Reduced Lymphodepletion Dose Plus GSK3377794 vs Standard Lymphodepletion Dose Plus GSK3377794: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02992743
GET https://conductscience.org/api/trials/v1/NCT02992743/registered?page=2