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| ID | Type | Description | Link |
|---|---|---|---|
| ADP-0011-007 | Other Identifier | Adaptimmune Therapeutics |
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This trial will evaluate safety and efficacy of Letetresgene autoleucel (GSK3377794) in participants with advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. This protocol investigates Letetresgene autoleucel treatment in Human Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO1+ advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letetresgene autoleucel (GSK3377794) | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letetresgene autoleucel (GSK3377794) | Drug | Letetresgene autoleucel (GSK3377794) as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | 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. | Up to 24 months |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response (TTR) Assessed by Investigator | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tampa | Florida | 33612 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39836945 | Derived | D'Angelo SP, Druta M, Van Tine BA, Liebner D, Schuetze SM, Tap WD, Preston J, Goodison S, D'Souza JW, Kapoor GS, Suchindran S, Zajic S, Bhaskar A, Kaczynski H, Kim J, Klohe E, Corigliano E, Eleftheriadou I, Nathenson MJ, Somaiah N. Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma. J Clin Oncol. 2025 May 20;43(15):1777-1788. doi: 10.1200/JCO-24-01466. Epub 2025 Jan 21. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 23 participants were enrolled in this study. Out of 23 participants, 20 participants received NY-ESO-1c259 T cell infusion.
This was an open-label study evaluating the safety and tolerability of autologous T-Cells expressing enhanced T-cell receptors (TCRs) specific for New York esophageal squamous cell carcinoma (NY-ESO)-1 (letetresgene autoleucel, lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with Advanced Myxoid/ Round Cell Liposarcoma.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 milligrams per meter square per day (mg/m^2/day) plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2021 | Oct 31, 2022 |
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| Cyclophosphamide | Drug | Cyclophosphamide will be used as a lymphodepleting chemotherapy. |
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| Fludarabine | Drug | Fludarabine will be used as a lymphodepleting chemotherapy. |
|
| Up to 24 months |
| Duration of Response (DOR) Assessed by Investigator | 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. | Up to 24 months |
| Progression Free Survival (PFS) Assessed by Investigator | 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. | Up to 24 months |
| Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment | 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. | Up to 24 months |
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer | 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. | Up to 24 months |
| Time to Response (TTR) Assessed by Independent Reviewer | 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. | Up to 24 months |
| Duration of Response (DOR) Assessed by Independent Reviewer | 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. | Up to 24 months |
| Progression Free Survival (PFS) Assessed by Independent Reviewer | 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. | Up to 24 months |
| Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. | Up to 24 months |
| Number of Participants With Adverse Event of Special Interest (AESI) | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome. | Up to 24 months |
| Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. | Up to 24 months |
| Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline | Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. | Up to 24 months |
| Number of Participants With Replication Competent Lentivirus (RCL) | RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). | Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion |
| Number of Participants With Insertional Oncogenesis | Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with >1% PBMC at >=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing >20% of the total. | Up to 2 years |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) | Serum samples were collected to analyze for the presence of ADAs using validated immunoassays. | Up to 24 Months |
| Maximum Transgene Expansion (Cmax) of GSK3377794 | Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax. | Day 2 to Day 15 |
| Time to Cmax (Tmax) | Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax. | Day 2 to Day 15 |
| Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794 | Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days). | Up to 28 days |
| Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval | Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. | Baseline, Day 1, Day 4 and Day 8 |
| Change From Baseline in ECG Mean Heart Rate | Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. | Baseline, Day 1 (Pre-dose), Day 4 and Day 8 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| FG001 | Standard Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1. |
| Received T-cell Infusion |
|
| COMPLETED | Participants who received T-cell infusion and were followed up in this study until death, 15 years post infusion or until transfer to the separate long term follow-up study are considered to have completed. |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1. |
| BG001 | Standard Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | 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. | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 24 months |
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| Primary | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment | 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. | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Count of Participants | Participants | Up to 24 months |
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| Secondary | Time to Response (TTR) Assessed by Investigator | 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Up to 24 months |
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| Secondary | Duration of Response (DOR) Assessed by Investigator | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to 24 months |
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| Secondary | Progression Free Survival (PFS) Assessed by Investigator | 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. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Median | 95% Confidence Interval | Months | Up to 24 months |
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| Secondary | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment | 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. | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Count of Participants | Participants | Up to 24 months |
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| Secondary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer | 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. | Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 24 months |
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| Secondary | Time to Response (TTR) Assessed by Independent Reviewer | 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Up to 24 months |
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| Secondary | Duration of Response (DOR) Assessed by Independent Reviewer | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to 24 months |
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| Secondary | Progression Free Survival (PFS) Assessed by Independent Reviewer | 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. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Median | 95% Confidence Interval | Months | Up to 24 months |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. | Intent-to-Treat (ITT) Population, which included all participants who underwent leukapheresis. | Posted | Count of Participants | Participants | Up to 24 months |
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| Secondary | Number of Participants With Adverse Event of Special Interest (AESI) | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Count of Participants | Participants | Up to 24 months |
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| Secondary | Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Count of Participants | Participants | Up to 24 months |
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| Secondary | Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline | Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. | Posted | Count of Participants | Participants | Up to 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Replication Competent Lentivirus (RCL) | RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.. Only those participants with RCL assessed post T-cell infusion were included in the analysis. | Posted | Count of Participants | Participants | Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Insertional Oncogenesis | Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with >1% PBMC at >=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing >20% of the total. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Number of participants analyzed comprises participants for whom integration site analysis was conducted. | Posted | Count of Participants | Participants | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) | Serum samples were collected to analyze for the presence of ADAs using validated immunoassays. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with post-baseline ADA results were analyzed. | Posted | Count of Participants | Participants | Up to 24 Months |
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Transgene Expansion (Cmax) of GSK3377794 | Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Copies per microgram genomic DNA | Day 2 to Day 15 |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) | Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Days | Day 2 to Day 15 |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794 | Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days). | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*copies per microgram genomic DNA | Up to 28 days |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval | Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. | Modified Intent-to-Treat (mITT) population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds (msec) | Baseline, Day 1, Day 4 and Day 8 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ECG Mean Heart Rate | Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. | Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute (beats/minute) | Baseline, Day 1 (Pre-dose), Day 4 and Day 8 |
|
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 30 months.
All cause mortality, SAEs and non-serious adverse events were reported for the Intent-to-Treat (ITT) population, which included all participants who underwent leukapheresis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1. | 5 | 13 | 5 | 13 | 13 | 13 |
| EG001 | Standard Lymphodepletion Dose Plus GSK3377794 | Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1. | 0 | 10 | 7 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Euthyroid sick syndrome | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Culture urine positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bursa disorder | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Metastases to skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Phantom limb syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2022 | Mar 21, 2023 | SAP_002.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018208 | Liposarcoma, Myxoid |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Male |
|
| Other: More than one race |
|
| White |
|
|
|
|
|
Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.
|
|
|
|
|
|
Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.
|
|
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Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.
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Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.
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| Standard Lymphodepletion Dose Plus GSK3377794 |
Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1. |
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