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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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This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.
This study is a master protocol. It has two sub studies registered as 209012 Sub Study 1 (NCT06048705) and 209012 Sub Study 2 (NCT05943990).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy. |
|
| Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy. |
|
| Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy. |
|
| Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3901961 | Drug | GSK3901961 as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled Across Sub Studies | Number of Participants Randomized across sub studies are presented. | Day -7 |
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Eligibility Criteria:
Inclusion criteria:
Additional criteria for participants with SS/ MRCLS:
Additional criteria for participants with non-small cell lung cancer (NSCLC):
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 | Jacksonville | Florida | 32224 | United States | ||
| GSK Investigational Site |
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.
This study and the sub studies associated were terminated due to a change in GSK's R&D priorities.
This master protocol study includes results data of screened participants for all the sub studies (NCT06048705 and NCT05943990). Results data is presented separately for 209012 Sub Study 1 (NCT06048705) and 209012 Sub Study 2 (NCT05943990). No participants were recruited for Sub Study 3. This is a master record and only contains data during screening phase (Day -35 to Day -8)
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| ID | Title | Description |
|---|---|---|
| FG000 | All Screened Participants | Participants with advanced tumors were screened for HLA/NY-ESO-1 expression |
| FG001 | Sub Study 1 (NCT06048705)-GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Screening (Day -35 to Day -8) |
|
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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 | May 27, 2022 | Dec 1, 2023 |
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This will be an open-label study. Hence, there will be no masking
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| GSK3845097 | Drug | GSK3845097 as an IV infusion. |
|
| GSK4427296 | Drug | GSK4427296 as an IV infusion. |
|
| Cyclophosphamide | Drug | Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route. |
|
| Fludarabine | Drug | Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route. |
|
| 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 | 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 | 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 |
Eligible participants were leukapheresed to manufacture engineered T cells. Participants then received 1 × 10^9 - 8 × 10^9 cells of GSK3901961 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participant 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 | Sub Study 1 (NCT06048705) GSK3901961 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 GSK3901961 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). |
| FG003 | Sub Study 1 (NCT06048705)-No Treatment | No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
| FG004 | Sub Study 2 (NCT05943990)-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). |
| FG005 | Sub Study 2 (NCT05943990)-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). |
| FG006 | Sub Study 2 (NCT05943990)-No Treatment | No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
|
| Participants Were Tested for HLA-type |
|
| Participants Tested for HLA-type and Were HLA Positive |
|
| Participants Tested HLA Positive and NY-ESO-1 Expression Positive |
|
| COMPLETED | Participants deemed eligible and enrolled |
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| NOT COMPLETED |
|
|
| Enrolled |
|
|
Intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sub Study 1 (NCT06048705)-GSK3901961 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 GSK3901961 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participant 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 | Sub Study 1 (NCT06048705) GSK3901961 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 GSK3901961 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 | Sub Study 1 (NCT06048705)-No Treatment | No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
| BG003 | Sub Study 2 (NCT05943990)-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). |
| BG004 | Sub Study 2 (NCT05943990)-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). |
| BG005 | Sub Study 2 (NCT05943990)-No Treatment | No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. |
| BG006 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 Enrolled Across Sub Studies | Number of Participants Randomized across sub studies are presented. | Screened Population includes all participants who signed an ICF to participate in the study. | Posted | Count of Participants | Participants | Day -7 |
|
|
|
Screening (Day -35 to Day -8)
Adverse events were not collected during screening.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Screened Participants | Participants with advanced tumors were screened for HLA/NY-ESO-1 expression | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Sub Study 1 (NCT06048705)-GSK3901961 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 GSK3901961 as an intravenous (IV) infusion in two aliquots (approximately 30% on Day 1 and approximately 70% on Day 8) for sentinel participant 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 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Sub Study 1 (NCT06048705) GSK3901961 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 GSK3901961 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Sub Study 1 (NCT06048705)-No Treatment | No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Sub Study 2 (NCT05943990)-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 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Sub Study 2 (NCT05943990)-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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Sub Study 2 (NCT05943990)-No Treatment | No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion. | 0 | 0 | 0 | 0 | 0 | 0 |
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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 10, 2023 | Dec 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 |
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| 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 |
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| Death prior to lymphodepletion |
|
| Did not meet Inclusion/Exclusion Criteria |
|
| Physician Decision |
|
| 19-64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Germany |
|
| Sweden |
|
| United States |
|