18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Up to 108 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant who received a study treatment and the event need not necessarily have a causal relationship with study treatment. An SAE is any AE that results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in a persistent or significant disability; is a congenital anomaly/birth defect; is clinically significant or requires intervention to prevent one of the outcomes listed before.
Any AE
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
3
Any SAE
Group
Value
95% CI
GSK3377794
2
GSK3377794+Pembrolizumab
2
Number of Participants With Treatment Limiting Toxicities-GSK3377794+Pembrolizumab Arm OnlyPrimary· Up to 3 weeks
The following toxicities were considered to be treatment limiting toxicities: any \>=Grade 4 AE; Grade 3 non-infectious pneumonitis and any other Grade 3 AE (excluding pneumonitis), that did not improve to Grade 2 within 7 days after onset despite medical management and supportive care. Exceptions included the following: Grade 3 or 4 leukopenia, lymphopenia, neutropenia, or febrile neutropenia; Grade 3 or 4 thrombocytopenia not associated with significant bleeding; Grade 3 anemia; Grade 4 cytokine release syndrome (CRS) or toxicities related to CRS that resolved to Grade \<=2 within 7 days; ot
Group
Value
95% CI
GSK3377794+Pembrolizumab
0
Number of Participants With Worst-case Chemistry Results by Any Grade Increase Post-Baseline Relative to BaselinePrimary· Up to 108 weeks
Blood samples were collected for the assessment of following clinical chemistry parameters: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, phosphate, sodium and calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE
Glucose (Hyperglycemia)
Group
Value
95% CI
GSK3377794
2
GSK3377794+Pembrolizumab
2
Glucose (Hypoglycemia)
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
0
Albumin (Hypoalbuminemia)
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
2
ALP increased
Group
Value
95% CI
GSK3377794
1
GSK3377794+Pembrolizumab
1
ALT increased
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
1
AST increased
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
1
Bilirubin increased
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
1
Creatinine increased
Group
Value
95% CI
GSK3377794
1
GSK3377794+Pembrolizumab
3
Number of Participants With Worst-case Hematology Results by Any Grade Increase Post-Baseline Relative to BaselinePrimary· Up to 108 weeks
Blood samples were collected for the assessment of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Laboratory parameters were graded according to NCI-CTCAE version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case post Baseline is presented.
Hemoglobin (Anemia)
Group
Value
95% CI
GSK3377794
2
GSK3377794+Pembrolizumab
3
Hemoglobin increased
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
0
Lymphocyte count decreased
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
3
Lymphocyte count increased
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
0
Neutrophil count decreased
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
3
Platelet count decreased
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
3
Leukocyte count decreased
Group
Value
95% CI
GSK3377794
3
GSK3377794+Pembrolizumab
3
Number of Participants With Worst-case Results for Coagulation Parameters Relative to Normal Range Post-Baseline Relative to BaselinePrimary· Up to 108 weeks
Blood samples were collected for the assessment of following coagulation parameters: prothrombin time and partial thromboplastin time (PTT). A laboratory value that is outside the normal range is considered either high abnormal (value above the upper limit of the normal range) or low abnormal (value below the lower limit of the normal range). Participants were counted twice if the participant had values in 'Decreased to low' and 'Increased to high' during the post-Baseline period. Data for worst case post Baseline is presented.
Prothrombin Time; decrease to low
Group
Value
95% CI
GSK3377794
0
Prothrombin Time; To normal or no change
Group
Value
95% CI
GSK3377794
0
Prothrombin Time; increase to high
Group
Value
95% CI
GSK3377794
1
PTT; decrease to low
Group
Value
95% CI
GSK3377794
0
PTT; To normal or no change
Group
Value
95% CI
GSK3377794
1
PTT; increase to high
Group
Value
95% CI
GSK3377794
0
Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) FindingsPrimary· Up to 108 weeks
ECG was recorded using an ECG machine that automatically calculated the heart rate and measured PR, RR, QRS and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal clinically significant ECG findings for worst case post-Baseline has been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Group
Value
95% CI
GSK3377794
0
GSK3377794+Pembrolizumab
1
Overall Response RateSecondary· Up to 108 weeks
Overall response rate is defined as the percentage of participants with a best overall response (BOR) of confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) Response Criteria (2016); where, PR: \>=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 milligrams (mg) per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-pro
Group
Value
95% CI
GSK3377794
33.3
0.8 – 90.6
GSK3377794+Pembrolizumab
66.7
9.4 – 99.2
Time to ResponseSecondary· Up to 108 weeks
Time to response is defined as the time interval (in months) from T-cell infusion to initial date of documented confirmed response (PR or better) in the subset of participants who showed a confirmed BOR of PR or better by Investigator assessment per IMWG (2016).
Group
Value
95% CI
GSK3377794
0.7
NA – NA
GSK3377794+Pembrolizumab
0.7
0.7 – 0.7
Duration of ResponseSecondary· Up to 108 weeks
Duration of response is defined as the interval between the initial date of the confirmed response (sCR, CR, VGPR, or PR) and the initial assesment date of confirmed progressive disease or death among participants with a confirmed response per IMWG (2016).
Group
Value
95% CI
GSK3377794
2.1
NA – NA
GSK3377794+Pembrolizumab
2.1
2.1 – 2.1
Progression-free SurvivalSecondary· Up to 108 weeks
Progression Free Survival is defined as the interval between the date of T-cell infusion and the initial assessment date of confirmed progressive disease as assessed by the investigator per IMWG (2016) or date of death. Progressive disease is defined as an increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>=0.5 grams per deciliter (g/dL); Serum M-protein increase \>=1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>=200 mg per 24 hours).
Group
Value
95% CI
GSK3377794
2.79
1.31 – 5.16
GSK3377794+Pembrolizumab
2.78
2.76 – 2.79
Maximum Persistence (Cmax) of GSK3377794Secondary· Up to 108 weeks
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).
Group
Value
95% CI
GSK3377794
38509.67
± 160.5
GSK3377794+Pembrolizumab
89640.56
± 84.8
Time to Maximum PersistenceSecondary· Up to 108 weeks
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
Group
Value
95% CI
GSK3377794
8.0
5 – 15
GSK3377794+Pembrolizumab
8.0
7 – 15
Adverse events — posted to ClinicalTrials.gov
Time frame: Non-serious AEs and SAEs were collected up to 108 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GSK3377794
Serious: 2/3 (67%)
Deaths: 2/3
GSK3377794+Pembrolizumab
Serious: 2/3 (67%)
Deaths: 0/3
Serious adverse events (6 terms)
Reaction
System
GSK3377794
GSK3377794+Pembrolizumab
Pancytopenia
Blood and lymphatic system disorders
—
—
Atrial flutter
Cardiac disorders
—
—
Bronchitis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05993299 — Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive
· Phase 2
· active not recruiting
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Trials by the same sponsor.
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· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03168438.