Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Liposarcoma

Sarcoma, Synovial

Liposarcoma, Myxoid

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

Myxoid Liposarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Letetresgene autoleucel will be administered.

Letetresgene autoleucel

Cyclophosphamide will be used as a lymphodepleting chemotherapy.

Fludarabine will be used as a lymphodepleting chemotherapy.

GSK Clinical Trials

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.

Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Evaluation of Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

ORR is 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. CR is defined as 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). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval.

Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. CR is defined as 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). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline).

Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease as assessed by local investigators, or death among participants with a confirmed response per RECIST 1.1. CR is defined as 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). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline).

DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as 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). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval.

PFS is defined as the interval of time between from the date of T-cell infusion to the earliest date of radiological progression of disease (PD) as assessed by local investigator per RECIST v1.1, or death due to any cause. The PD is defined as the date of radiological disease progression based on imaging data per RECIST v1.1.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. 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.

RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).

Instances of Insertional Oncogenesis (IO) was summarized descriptively.

Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis.

Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis.

Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis.

GlaxoSmithKline

All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.

Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m\^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m\^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10\^9 to 15×10\^9 transduced T cells.

Letetresgene Autoleucel (Lete-cel)

Age, Continuous

<=18 years

19-64 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

Netherlands

United Kingdom

United States

Region of Enrollment

GSK Response Center

Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel.

Overall Response Rate (ORR)

Time to Response (TTR)

Duration of Response (DOR)

Disease Control Rate (DCR)

Progression Free Survival (PFS)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Number of Participants With AEs of Special Interest (AESIs)

Number of Participants With TEAEs and TESAEs by Severity

Number of Participants With AESIs by Severity

Percentage of Participants With Replication Competent Lentivirus (RCL) Positive

Instances of Insertional Oncogenesis (IO)

Pharmacokinetic (PK) population included participants in the safety population from whom at least one persistence sample was obtained, analyzed and was measurable.

Maximum Transgene Expansion (Cmax)

Time to Cmax (Tmax)

Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])

Overall Study

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Recurrence

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Esophageal Squamous Cell Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

In Arm A, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel monotherapy. Participants who subsequently progress by Week 25 will be offered pembrolizumab.

In Arm B, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.

In Arm C, participants with NSCLC (with actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.

lete-cel will be administered to eligible participants.

Lete-cel

Pembrolizumab will be administered to eligible participants.

This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.

New York esophageal squamous cell carcinoma-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T- cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. This is a multi-arm, open-label study of letetresgene autoleucel (lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive adults whose tumors express NY-ESO-1 and/or LAGE-1a. This study will enroll participants who have unresectable Stage IIIb or Stage IV NSCLC.

Participants will receive GSK3377794, either as monotherapy or in combination with pembrolizumab.

This will be an open-label study. Hence, there will be no masking.

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

IPD for this study will be made available via the Clinical Study Data Request site.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.

AESI included cytokine release syndrome (CRS), pneumonitis/pneumonia, graft vs host disease (GvHD), guillain barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP), pancytopenia/aplastic anemia (including analysis of all hematopoietic cytopenias), immune effector cell-associated neurotoxicity syndrome (ICANS) and treatment-related inflammatory response at tumor site. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.

An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as TE. Severity was reported during study and was assigned a grade according to the National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). SAEs are subset of AEs. AEs and SAEs severity graded on a 5-point scale as: 1 = mild, 2 = moderate discomfort, 3 = severe, 4 = life-threatening and 5 = death due to AE.

An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to dose delays were summarized.

Overall response rate (ORR) defined as the percentage of participants with a complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria in Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is 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 is 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.

Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.

DCR was defined as the percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months as per RECIST v1.1. Partial response is 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 is 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). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.

Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is 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 is 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.

Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is 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 is 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 mm.

Cmax was defined as peak cell expansion during the study. Blood samples were collected for analysis of Cmax of lete-cel.

Tmax was defined as time to reach peak cell expansion during the study. Blood samples were collected for analysis of Tmax of lete-cel.

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).

Merck Sharp & Dohme LLC

All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.

Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.

Arm A: Lete-cel Monotherapy

Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.

Arm C: Lete-cel + Pembrolizumab

Participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy or T-cell infusion.

No Treatment

Total

Asian

White

Unknown or Not Reported

Race/Ethnicity, Customized

SAEs

Modified Intent-to-Treat (mITT) population included all participants who received Lete-cel infusion.

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Modified Intent to Treat (mITT) population.

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

AEs, Grade 2

AEs, Grade 3

AEs, Grade 4

AEs, Grade 5

SAEs, Grade 3

SAEs, Grade 4

SAEs, Grade 5

Modified intent-to-treat (mITT) population

Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades

Number of Participants With AEs Leading to Dose Delays

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment

Progression-free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment

Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment

Modified intent-to-treat (mITT) population. Only participants with CR or PR were included in the analysis. No participant achieved CR or PR, hence the number of participants analyzed is 0.

Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment

Time to Response (TTR) Per RECIST Version 1.1 by Investigator Assessment

Pharmacokinetic (PK) population included all participants in the mITT population from whom at least one PK sample was obtained, analyzed, and was measurable.

Maximum Transgene Expansion (Cmax) of Lete-cel

Time to Cmax (Tmax) of Lete-cel

Area Under the Plasma Concentration-time Curve to Day 28 (AUC0-28d) of Lete-cel

After screening, eligible subjects will enter a leukapheresis phase, followed by lymphodepletion phase where they will be administered fludarabine and cyclophosphamide. On Day 1, subjects will receive a single dose of GSK3377794 administered as an intravenous infusion of 1 to 6 x10\^9 total transduced cells. On Day 22, subjects will be administered pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks for adults and 2 mg/kilogram (kg) (up to 200 mg) once every 3 weeks for children for up to 35 cycles (2 years) or until subsequent disease progression.

GSK3377794 is genetically engineered NY-ESO-1 Specific (c259) T cells.

GSK3377794

Pembrolizumab will be administered at a dose of 200 mg once every 3 weeks for adults and 2 mg/kg (up to 200 mg) once every 3 weeks for children.

Adoptive T-cell therapy is a therapeutic approach that aims to generate an anti-tumor T-cell immune response by infusing a cancer subjects own T-cells obtained by leukapheresis, engineered and expanded in-vitro to express a tumor specific T-cell receptor. NY-ESO-1 and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types, including synovial sarcoma. This is an open-label study to evaluate the safety and efficacy of GSK3377794 (genetically engineered NY-ESO-1 Specific \[c259\] T Cells), in combination with anticancer agents including pembrolizumab in subjects with NY-ESO-1 and/or LAGE-1a positive relapsed and refractory synovial sarcoma. The study will consist of a target expression screening to determine if subjects are human leukocyte antigen (HLA)-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive and if their tumors express NY-ESO-1 and/or LAGE-1a, followed by a leukapheresis screening phase of up to 42 days prior to leukapheresis. Eligible subjects will enter a leukapheresis phase followed by lymphodepletion phase with cyclophosphamide and fludarabine. During the treatment phase, subjects will be administered GSK3377794 on Day 1 followed by pembrolizumab infusion once every 3 weeks from Day 22 (or Week 7) for up to 2 years. There will be a long-term follow-up phase from the end of treatment phase and for up to 15 years from the date of GSK3377794 administration.

This is an open-label, single arm treatment study.

Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a

Open-Label Phase 1b/2a Clinical Trial to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells (GSK3377794) in Combination With Anti-Cancer Agents Including Pembrolizumab in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Synovial Sarcoma

The following toxicities will be considered as TLTs: Any \>=Grade 4 adverse event (AE) except for Grade 4 fever and chills and Grade 4 hypoalbuminemia or abnormal electrolytes that are responding to supplementation/correction; Grade 3 non-infectious pneumonitis; Any other Grade 3 AE (excluding pneumonitis), that does not improve to Grade 2 within 7 days after onset despite medical management and supportive care; Any AE that permanently prevents subject from dosing with pembrolizumab in this trial.

An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

The severity of AEs will be graded according to National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) version 4.03.

An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events that may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Number of subjects with AE /SAEs leading to pembrolizumab administration delay, interruptions, and withdrawals will be summarized.

Blood samples will be collected for the assessment of the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.

Blood samples will be collected for the assessment of the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, albumin, potassium, sodium, calcium, phosphorus, magnesium, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase (LDH), bicarbonate, total and direct bilirubin, total protein, chloride and urea.

Urine samples will be collected for the analysis of the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite and leukocyte esterase by dipstick.

Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, and pulse rate.

For subjects \>10 years of age, the performance status will be assessed using ECOG.

For subjects \<=10 years of age, the performance status will be assessed using Lansky scale.

12-lead ECG will be obtained in triplicate using an automated ECG machine.

Overall response rate is defined as the percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Progression-free survival is defined as the time from the date of T-cell infusion until the earliest date of disease progression (PD) as assessed by the investigator per RECIST version 1.1, or death due to any cause.

Disease Control Rate is defined as the percentage of subjects with a confirmed CR, PR, or stable disease (SD) for at least 6 months as per RECIST version 1.1.

Duration of response is defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death, in the subset of subjects who show a confirmed CR or PR.

Time to response is defined as the time from the first dose to the first documented evidence of CR or PR for subjects with a confirmed CR or PR.

Peripheral blood samples will be collected at indicated time points for measurement of GSK3377794 transduced cell quantities. GSK3377794 T-cell persistence in the peripheral blood will be measured to establish the relationship between persistence and response to GSK3377794.

Biopsy of tumor tissue will be obtained to assess the tissue expression of the target antigen NY-ESO-1 and/or LAGE-1a.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma	NCT05993299	Neoplasms	Letetresgene au... Cyclophosphamid... Fludarabine	10 Years -	GlaxoSmithKline
Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab	NCT03709706	Neoplasms	Lete-cel Pembrolizumab	18 Years -	GlaxoSmithKline
Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a	NCT03697824	Neoplasms	GSK3377794 Pembrolizumab Fludarabine Cyclophosphamid...	10 Years -	GlaxoSmithKline
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma	NCT05993299	Neoplasms	Letetresgene au... Cyclophosphamid... Fludarabine	10 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for gsk3377794

Every month we try and update this database with for gsk3377794 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gsk3377794

Every month we try and update this database with for gsk3377794 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gsk3377794 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.