Trial Outcomes & Findings for Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer (NCT NCT06048705)

Last Updated: 2024-11-13

Results Overview

DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3901961 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3901961 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 GSK3901961 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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2024-11-13

Participant Flow

This study is a sub study of the master protocol (NCT04526509). The study was terminated due to a change in GSK's R\&D priorities.

Participant milestones

Participant milestones
Measure	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).	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).	No Treatment No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
Overall Study STARTED	1	4	2
Overall Study Transferred to Long-term Follow-up Study	0	2	0
Overall Study Death Post Lymphodepletion	0	2	0
Overall Study COMPLETED	0	4	0
Overall Study NOT COMPLETED	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	No Treatment No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
Overall Study Physician Decision	1	0
Overall Study Did not meet Inclusion/Exclusion Criteria	0	1
Overall Study Death prior to lymphodepletion	0	1

Baseline Characteristics

Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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).	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).	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.	Total n=7 Participants Total of all reporting groups
Age, Continuous	27 years n=5 Participants	51.5 years STANDARD_DEVIATION 17.79 • n=7 Participants	43.0 years STANDARD_DEVIATION 0.00 • n=5 Participants	45.6 years STANDARD_DEVIATION 15.53 • n=4 Participants
Age, Customized Age, customized · 19-64	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Customized Age, customized · >=65	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 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
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 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
Race/Ethnicity, Customized White	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment Australia	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Germany	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 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

PRIMARY outcome

Timeframe: Up to 28 days

Population: 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.

Outcome measures

Outcome measures
Measure	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).	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).
Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 21 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	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).	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).
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs, Grade 1	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs, Grade 2	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs, Grade 3	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs, Grade 4	1 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs, Grade 5	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs, Grade 1	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs, Grade 2	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs, Grade 3	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs, Grade 4	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs, Grade 5	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 21 months

Population: Modified intent-to-treat (mITT) population

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.

Outcome measures

Outcome measures
Measure	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).	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).
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Participants with any AESI	1 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Cytokine Release Syndrome (CRS)	1 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Graft versus host disease	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Haematopoietic cytopenias (including pancytopenia and aplastic anaemia)	1 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Immune Effector-Cell Associated Neurotoxicity Syndrome	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: Modified intent-to-treat (mITT) population

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.

Outcome measures

Outcome measures
Measure	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).	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).
Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1	100 percentage of participants Interval 2.5 to 100.0	50 percentage of participants Interval 6.8 to 93.2

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: Modified intent-to-treat (mITT) population. Only responders (CR or PR) by investigator assessment were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	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).	GSK3901961 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 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).
Duration of Response (DoR)	1.22 Months Full range is not applicable as only a single participant was analyzed. Median value presented here is the duration of response for this single participant who was censored at their last tumor assessment prior to study withdrawal.	2.96 Months Interval 2.8 to 3.1

SECONDARY outcome

Timeframe: Up to 21 days

Population: Pharmacokinetic population included participants from the mITT population for whom at least one persistence sample was obtained, analysed, and was measurable.

Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.

Outcome measures

Outcome measures
Measure	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).	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).
Maximum Transgene Expansion (Cmax) of GSK3901961	121973 Copies per microgram genomic DNA Geometric Coefficient of Variation NA Geometric coefficient of variation is not applicable as only a single participant was analyzed. Geometric mean value presented here is the actual Cmax.	29058.02 Copies per microgram genomic DNA Geometric Coefficient of Variation 401.296

SECONDARY outcome

Timeframe: Up to 21 days

Population: Pharmacokinetic population included participants from the mITT population for whom at least one persistence sample was obtained, analyzed, and was measurable.

Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.

Outcome measures

Outcome measures
Measure	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).	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).
Time to Cmax (Tmax) of GSK3901961	21 days Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual Tmax for this single participant.	7.5 days Interval 1.0 to 20.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: Pharmacokinetic population

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).

Outcome measures

Outcome measures
Measure	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).	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).
Area Under the Time Curve From Zero to Time 28 Days AUC(0-28)	2267635.372 Days*copies per microgram genomic DNA Geometric Coefficient of Variation NA Geometric coefficient of variation is not applicable as only a single participant was analyzed. Geometric mean value presented here is the actual AUC(0-28).	374639.00 Days*copies per microgram genomic DNA Geometric Coefficient of Variation 371.441

Adverse Events

GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

No Treatment

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells n=1 participants at risk 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).	GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells n=4 participants at risk 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).	No Treatment n=2 participants at risk No Treatment arm consisted of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Cardiac disorders Pericardial effusion	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	50.0% 1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	25.0% 1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
General disorders Non-cardiac chest pain	100.0% 1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
General disorders Pyrexia	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Immune system disorders Graft versus host disease in skin	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	25.0% 1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	25.0% 1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.	0.00% 0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months. All-cause mortality, SAEs and non-SAEs were reported for intent-to-treat (ITT) population that included all participants who started leukapheresis procedure.

Other adverse events

Additional Information

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