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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004446-14 | EudraCT Number |
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The study was terminated due to a change in GSK's R&D priorities.
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To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) positive, previously treated, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS).
This study is a substudy of the Master record - (209012) NCT04526509.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3845097 | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive high dose of GSK3845097 after completing lymphodepleting chemotherapy. The first study participant receiving GSK3845097 will receive the total assigned dose as 2 separate infusions 7 days apart, in aliquots of 30% (first infusion) and 70% (second infusion) of the total target dose , respectively. Based on the dose limiting toxicities reported in the first participant, then all subsequent participants treated with GSK3845097 will receive the full dose as a single, i.e., one-time, infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3845097 | Drug | GSK3845097 was administered. |
| |
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3845097 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3845097 and do not resolve to Gr <=1 (or Baseline) within 7 days from the onset of the event 3) Gr >=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3845097 that does not improve to Gr <2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr <=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr <=2 within 72 hours 7) Any Gr >=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for >72 hours and occurs within 28 days of infusion. | Up to 28 days |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity | An adverse event (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. AEs and SAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. SAEs are subset of AEs. Results for maximum severity grades has been presented. | Up to approximately 21 months |
| Number of Participants With Treatment Emergent Adverse Events 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. AESIs 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), Guillain-Barre Syndrome (GBS), Pneumonitis and treatment-related inflammatory response at tumor site(s) and Neutropenia Grade 4 lasting more than or equal to 28 days. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1 | 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 Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. Partial response (PR) was 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 (CR) was 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adaptimmune Patient Enquiries | Adaptimmune | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | New Haven | Connecticut | 06504 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
This study is a sub study of the master protocol (NCT04526509). This sub study was terminated due to a change in GSK's R&D priorities.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 1 × 10^9 - 8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participants or all at once on Day 1 for all other participants after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2022 | Sep 1, 2023 |
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| Drug |
Cyclophosphamide was administered as lymphodepleting chemotherapy. |
|
| Fludarabine | Drug | Fludarabine was administered as lymphodepleting chemotherapy. |
|
| Up to approximately 21 months |
| Up to approximately 21 months |
| Duration of Response (DoR) | DoR is defined as the interval of time (in months) from first documented evidence of the confirmed response (PR or CR) as assessed by local investigators to the date of disease progression per RECIST v1.1 or death due to any cause, among participants with a confirmed response of PR or CR. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | Up to approximately 21 months |
| Maximum Transgene Expansion (Cmax) of GSK3845097 | Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax. | Up to 21 days |
| Time to Cmax (Tmax) of GSK3845097 | Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax. | Up to 21 days |
| Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | 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 |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| GSK Investigational Site | Tampa | Florida | 33612 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Westwood | Kansas | 66205 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21287 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Melbourne | Victoria | 3000 | Australia |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| GSK Investigational Site | Munich | Bavaria | 81377 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Amsterdam | 1066 CX | Netherlands |
| GSK Investigational Site | Stockholm | SE-171 64 | Sweden |
| FG001 | GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
| FG002 | No Treatment | No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
| COMPLETED | Participants who received T cell infusion and were followed up in this study until death or until transfer to the separate long term follow-up study are considered to have completed. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 1 × 10^9 - 8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participants or all at once on Day 1 for all other participants after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
| BG001 | GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
| BG002 | No Treatment | No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3845097 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3845097 and do not resolve to Gr <=1 (or Baseline) within 7 days from the onset of the event 3) Gr >=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3845097 that does not improve to Gr <2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr <=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr <=2 within 72 hours 7) Any Gr >=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for >72 hours and occurs within 28 days of infusion. | DLT Evaluable included participants in the mITT population (all ITT participants (All participants who started leukapheresis procedure) who received any dose of New York esophageal antigen-1 [NY ESO 1] specific T cells) who are part of the dose confirmation phase that either had a DLT or have completed the DLT assessment period of 28 days since last T cell infusion. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity | An adverse event (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. AEs and SAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. SAEs are subset of AEs. Results for maximum severity grades has been presented. | Modified intent-to-treat (mITT) population included all ITT participants (All participants who started leukapheresis procedure) who received any dose of NY ESO 1 specific T cells. | Posted | Count of Participants | Participants | Up to approximately 21 months |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events 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. AESIs 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), Guillain-Barre Syndrome (GBS), Pneumonitis and treatment-related inflammatory response at tumor site(s) and Neutropenia Grade 4 lasting more than or equal to 28 days. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. | Modified intent-to-treat (mITT) population included all ITT participants (All participants who started leukapheresis procedure) who received any dose of NY ESO 1 specific T cells. | Posted | Count of Participants | Participants | Up to approximately 21 months |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1 | 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 Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. Partial response (PR) was 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 (CR) was 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DoR is defined as the interval of time (in months) from first documented evidence of the confirmed response (PR or CR) as assessed by local investigators to the date of disease progression per RECIST v1.1 or death due to any cause, among participants with a confirmed response of PR or CR. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | Modified intent-to-treat (mITT) population. Only responders (CR or PR) by investigator assessment were included in this analysis. The participants analyzed in the arm (GSK3845097 0.1 × 10^9 - 0.8 × 10^9 cells) is 0, as there were no confirmed response of PR or CR. | Posted | Mean | Standard Deviation | Months | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Transgene Expansion (Cmax) of GSK3845097 | Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax. | Pharmacokinetic population included participants from the mITT population for whom at least one persistence sample was obtained, analysed, and was measurable. | Posted | Geometric Mean | Geometric Coefficient of Variation | Copies per microgram genomic DNA | Up to 21 days |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) of GSK3845097 | Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax. | Pharmacokinetic population included participants from the mITT population for whom at least one persistence sample was obtained, analyzed, and was measurable. | Posted | Median | Full Range | Days | Up to 21 days |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | 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). | Pharmacokinetic population included participants from the mITT population for whom at least one persistence sample was obtained, analyzed, and was measurable. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*copies per microgram genomic DNA | Up to 28 days |
|
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 21 months.
All cause mortality, SAEs and non-serious adverse events were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
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 | GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 1 × 10^9 - 8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participants or all at once on Day 1 for all other participants after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). | 0 | 2 | 1 | 2 | 2 | 2 |
| EG001 | GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). | 2 | 2 | 2 | 2 | 2 | 2 |
| EG002 | No Treatment | No Treatment consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. | 0 | 1 | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Interleukin level increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (26.0) | 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 | Apr 3, 2023 | Sep 1, 2023 | SAP_001.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
| 18-64 years |
|
| >=65 years |
|
| Male |
|
| White |
|
| Sweden |
|
| United States |
|
| OG001 | GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
|
|
| GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
|
|
| OG001 |
| GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
|
|
| GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 0.1 × 10^9 - 0.8 × 10^9 cells of GSK3845097 as an intravenous (IV) infusion on Day 1 after completing lymphodepleting chemotherapy regimen that generally consisted of 30 milligram (mg)/meter (m)^2/day fludarabine for 4 days (Day -7 to -4) and 900mg/ m^2/day cyclophosphamide for 3 days (Day -6 to -4). |
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