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 Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Up to 24 months
An 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. An SAE is 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 or is clinically significant or requires intervention to prevent one of the outcomes listed before. Number of participants with common (greater
Non SAEs
Group
Value
95% CI
Lete-cel
6
SAEs
Group
Value
95% CI
Lete-cel
4
Number of Participants With Hematology Results by Maximum Grade Increase Post-BaselinePrimary· Up to 24 months
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. 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. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grad
Hemoglobin increased
Group
Value
95% CI
Lete-cel
0
Hemoglobin (Anemia)
Group
Value
95% CI
Lete-cel
3
Lymphocytes increased
Group
Value
95% CI
Lete-cel
1
Lymphocytes decreased
Group
Value
95% CI
Lete-cel
5
Neutrophils
Group
Value
95% CI
Lete-cel
5
Platelets
Group
Value
95% CI
Lete-cel
5
Leukocytes (Leukocytosis)
Group
Value
95% CI
Lete-cel
0
Leukocytes (Leukopenia)
Group
Value
95% CI
Lete-cel
5
Number of Participants With Any Grade Increase in Clinical Chemistry ParametersPrimary· Up to 24 months
Blood samples were collected for analysis of clinical chemistry parameters: glucose (Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bil), creatinine (Creat), potassium (Pot), magnesium (Mg), phosphate (Ph), sodium (Sod) and calcium. 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
Gl, Hyperglycemia
Group
Value
95% CI
Lete-cel
2
Gl, Hypoglycemia
Group
Value
95% CI
Lete-cel
0
Albumin
Group
Value
95% CI
Lete-cel
2
ALP
Group
Value
95% CI
Lete-cel
2
ALT
Group
Value
95% CI
Lete-cel
3
AST
Group
Value
95% CI
Lete-cel
4
Bil
Group
Value
95% CI
Lete-cel
1
Creat
Group
Value
95% CI
Lete-cel
1
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) FindingsPrimary· Up to 24 months
12-lead ECGs were recorded in semi-supine position after 5 minutes rest 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 not clinically significant (NCS) and clinically significant (CS) ECG findings for worst case post-Baseline have 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 expecte
Abnormal, NCS
Group
Value
95% CI
Lete-cel
2
Abnormal, CS
Group
Value
95% CI
Lete-cel
1
Change From Baseline in Oxygen SaturationPrimary· Baseline, Day 1 (pre-dose, 5, 15, and 30 minutes, 1, 1.5, 2, and 4 hours post dose), Days 2, 3, 4, 5, 8 and Week 2
Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen saturation was measured using a pulse oximeter. Baseline is the most recent, non-missing value within 7 days prior to initiating the lymphodepleting chemotherapy. Change from Baseline is the post-Baseline visit value minus Baseline value.
Day 1, pre dose, n=5
Group
Value
95% CI
Lete-cel
2.0
-2 – 6
Day 1, 5 minutes post dose, n=4
Group
Value
95% CI
Lete-cel
2.5
1 – 3
Day 1, 15 minutes post dose, n=4
Group
Value
95% CI
Lete-cel
2.0
-3 – 5
Day 1, 30 minutes post dose, n=4
Group
Value
95% CI
Lete-cel
3.0
-2 – 3
Day 1, 1 hour post dose, n=5
Group
Value
95% CI
Lete-cel
2.0
-2 – 5
Day 1, 1.5 hours post dose, n=2
Group
Value
95% CI
Lete-cel
1.5
1 – 2
Day 1, 2 hours post dose, n=3
Group
Value
95% CI
Lete-cel
3.0
2 – 5
Day 1, 4 hours post dose, n=4
Group
Value
95% CI
Lete-cel
-1.0
-3 – 3
Overall Response Rate (ORR)Secondary· Up to 24 Months
ORR is defined as the percentage of participants with a confirmed Partial response (PR) or Complete response (CR) as the Best overall response (BOR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Confidence Interval (CI) was calculated using the exact method. 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-targe
Group
Value
95% CI
Lete-cel
20
0.5 – 71.6
Time to ResponseSecondary· Up to 24 months
Time to response is defined as the interval of time (in months) between the date of T-cell infusion and the first documented evidence of response (PR or CR) in the subset of participants with a confirmed PR or CR as the BOR as assessed by the investigator per RECIST v1.1.
Group
Value
95% CI
Lete-cel
12.09
Duration of ResponseSecondary· Up to 24 months
Duration of response (DoR), defined as the interval of time in months from first documented evidence of PR or better to the time when disease progression is documented as assessed by RECIST v1.1 or death due to any cause among participants with a confirmed PR or CR as the BOR.
Group
Value
95% CI
Lete-cel
6.18
Disease Control Rate (DCR)Secondary· Up to 24 months
DCR is defined as the percentage of participants with a stable disease (SD) or better as the BOR (Confirmed PR, confirmed CR, or SD \>=12 weeks), as assessed by the investigator per RECIST v1.1. CI was calculated using the exact method.
Group
Value
95% CI
Lete-cel
20
0.5 – 71.6
Progression-Free Survival (PFS) by Investigator AssessmentSecondary· Up to 24 months
Progression-free survival (PFS) is defined as the interval of time (in months) between the date of T-cell infusion and the earlier of the date of disease progression as assessed by the investigator and the date of 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. Median and inter-quartile range (first quartile and third quartile) are presented.
Group
Value
95% CI
Lete-cel
1.81
0.99 – 5.29
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, SAEs and common (>=5%) non-serious AEs were collected from the enrollment to 24 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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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: 5 September 2021
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/NCT02588612.