Trial Outcomes & Findings for Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (NCT NCT04526509)
NCT ID: NCT04526509
Last Updated: 2024-11-26
Results Overview
Number of Participants Randomized across sub studies are presented.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day -7
Results posted on
2024-11-26
Participant Flow
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)
This study and the sub studies associated were terminated due to a change in GSK's R\&D priorities.
Participant milestones
| Measure |
All Screened Participants
Participants with advanced tumors were screened for HLA/NY-ESO-1 expression
|
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).
|
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).
|
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.
|
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).
|
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).
|
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.
|
|---|---|---|---|---|---|---|---|
|
Screening (Day -35 to Day -8)
STARTED
|
327
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Participants Were Tested for HLA-type
|
277
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Participants Tested for HLA-type and Were HLA Positive
|
146
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Participants Tested HLA Positive and NY-ESO-1 Expression Positive
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
COMPLETED
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
NOT COMPLETED
|
315
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrolled
STARTED
|
0
|
1
|
4
|
2
|
2
|
2
|
1
|
|
Enrolled
COMPLETED
|
0
|
0
|
4
|
0
|
2
|
2
|
0
|
|
Enrolled
NOT COMPLETED
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
All Screened Participants
Participants with advanced tumors were screened for HLA/NY-ESO-1 expression
|
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).
|
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).
|
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.
|
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).
|
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).
|
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.
|
|---|---|---|---|---|---|---|---|
|
Screening (Day -35 to Day -8)
Not tested for both HLA-type and NY-ESO-1 tumor expression
|
40
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Tested for NY-ESO-1 tumor expression but not HLA-type and were NY-ESO-1 negative
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Tested for NY-ESO-1 but not HLA-type and were NY-ESO-1 positive but not met other inclusion criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Tested for HLA-type and were HLA negative
|
131
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
Tested HLA positive and were NY-ESO-1 Negative or Not Evaluable
|
97
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
HLA and NY-ESO-1 expression positive but not enrol in the study due to study terminated by sponsor
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
HLA and NY-ESO-1 expression positive and did not meet inclusion/exclusion criteria
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
HLA and NY-ESO-1 expression positive and did not enrol due to physician decision
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
HLA and NY-ESO-1 expression positive and did not enrol as met eligibility criteria but not needed
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening (Day -35 to Day -8)
HLA and NY-ESO-1 expression positive and did not enrol due to withdrawal by participant
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrolled
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Enrolled
Death prior to lymphodepletion
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Enrolled
Did not meet Inclusion/Exclusion Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Enrolled
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Sub Study 1 (NCT06048705)-GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells
n=1 Participants
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).
|
Sub Study 1 (NCT06048705) GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells
n=4 Participants
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).
|
Sub Study 1 (NCT06048705)-No Treatment
n=2 Participants
No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
|
Sub Study 2 (NCT05943990)-GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells
n=2 Participants
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).
|
Sub Study 2 (NCT05943990)-GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells
n=2 Participants
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).
|
Sub Study 2 (NCT05943990)-No Treatment
n=1 Participants
No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
19-64 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day -7Population: Screened Population includes all participants who signed an ICF to participate in the study.
Number of Participants Randomized across sub studies are presented.
Outcome measures
| Measure |
All Screened Participants
n=327 Participants
Participants with advanced tumors were screened for HLA/NY-ESO-1 expression
|
|---|---|
|
Number of Participants Enrolled Across Sub Studies
Sub Study 1
|
7 Participants
|
|
Number of Participants Enrolled Across Sub Studies
Sub Study 2
|
5 Participants
|
Adverse Events
All Screened Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 1 (NCT06048705)-GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 1 (NCT06048705) GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 1 (NCT06048705)-No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 2 (NCT05943990)-GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 2 (NCT05943990)-GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub Study 2 (NCT05943990)-No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER