Trial Outcomes & Findings for Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma (NCT NCT05943990)

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 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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

5 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). This sub study was terminated due to a change in GSK's R\&D priorities.

Participant milestones

Participant milestones
Measure	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).	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).	No Treatment No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
Overall Study STARTED	2	2	1
Overall Study COMPLETED	2	2	0
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).	No Treatment No Treatment arm consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
Overall Study Study Terminated by Sponsor	0	0	1

Baseline Characteristics

Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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).	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).	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=5 Participants Total of all reporting groups
Age, Continuous	29.0 Years STANDARD_DEVIATION 2.83 • n=5 Participants	60.0 Years STANDARD_DEVIATION 9.90 • n=7 Participants	41.0 Years n=5 Participants	43.8 Years STANDARD_DEVIATION 16.41 • n=4 Participants
Age, Customized <=17 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 18-64 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Customized >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 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	2 Participants n=5 Participants	0 Participants n=7 Participants	0 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	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).	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).
Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants	2 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	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).	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).
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs-Grade 4	2 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity AEs-Grade 5	0 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs-Grade 4	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity SAEs-Grade 5	0 Participants	2 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 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	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).	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).
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Participants with any AESI	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Cytokine Release Syndrome (CRS)	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Graft versus host disease	1 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Haematopoietic cytopenias (including pancytopenia and aplastic anaemia)	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI) Immune Effector-Cell Associated Neurotoxicity Syndrome	1 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	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).	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).
Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1	50.0 Percentage of participants Interval 1.3 to 98.7	0.0 Percentage of participants Interval 0.0 to 84.2

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. 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.

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	GSK3845097 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 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).	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).
Duration of Response (DoR)	2.53 Months	—

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	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).	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).
Maximum Transgene Expansion (Cmax) of GSK3845097	54606.56 Copies per microgram genomic DNA Geometric Coefficient of Variation 139.944	105446.79 Copies per microgram genomic DNA Geometric Coefficient of Variation 74.752

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	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).	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).
Time to Cmax (Tmax) of GSK3845097	14.0 Days Interval 7.0 to 21.0	10.5 Days Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Up to 28 days

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

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	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).	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).
Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])	730937.83 Days*copies per microgram genomic DNA Geometric Coefficient of Variation 151.154	1325540.63 Days*copies per microgram genomic DNA Geometric Coefficient of Variation 4.115

Adverse Events

GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

Measure	GSK3845097 1 × 10^9 - 8 × 10^9 Transduced Cells n=2 participants at risk 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).	GSK3845097 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells n=2 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 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).	No Treatment n=1 participants at risk No Treatment consists of participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy and T cell infusion.
General disorders Pyrexia	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 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.	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 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.	0.00% 0/1 • 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.
General disorders Systemic inflammatory response syndrome	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Blood and lymphatic system disorders Febrile neutropenia	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 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.	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 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.	0.00% 0/1 • 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.
Blood and lymphatic system disorders Aplastic anaemia	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Blood and lymphatic system disorders Pancytopenia	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Infections and infestations COVID-19 pneumonia	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Infections and infestations Herpes zoster	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Infections and infestations Staphylococcal infection	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Infections and infestations Vascular device infection	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Hepatobiliary disorders Hyperbilirubinaemia	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Immune system disorders Graft versus host disease in skin	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Investigations Alanine aminotransferase increased	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Investigations International normalised ratio increased	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome	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 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.	0.00% 0/2 • 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.	0.00% 0/1 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • 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.	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 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.	0.00% 0/1 • 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.