Clinical trial · Interventional
Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
A Pilot Open-Label Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for NY-ESO-1 in Subjects With Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
NCT02588612CI-TRIAL-00053694completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| letetresgene autoleucel (GSK3377794) | Drug | Letetresgene Autoleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- letetresgene autoleucel (GSK3377794)
- description
- Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy.
- interventionNames
- Drug: letetresgene autoleucel (GSK3377794)
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (5)
- measure
- Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Up to 24 months
- description
- 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 than or equal to \[\>=\]5 percent\[%\]) non-serious AEs and SAEs are presented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is \>=18 years of age on the day of signing informed consent. * Participant has a diagnosis of histologically or cytologically confirmed advanced non-small cell lung cancer (Stage IIIB or IV) or recurrent disease. * Participants with known epidermal growth factor receptor (EGFR) mutations or Anaplastic lymphoma kinase receptor (ALK) or ROS1 gene rearrangements must have failed (disease progression \[PD\] or unacceptable toxicity) prior EGFR or ALK or ROS1 tyrosine kinase inhibitor, respectively (PD or unacceptable toxicity). There is no limit to lines of prior anti-cancer therapy. * Participant has measurable disease according RECIST v1.1 criteria. * Participant is HLA-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive. * Participant's tumor is positive for NYESO and/or LAGE-1a expression by a designated central laboratory. * Participant has Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Participant has an anticipated life expectancy \>3 months. * Participant has left ventricular ejection fraction \>=50 percent(%). * Participant is fit for leukapheresis and has adequate venous access for the cell collection. * Male or Female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Participant must have adequate organ function. Exclusion Criteria: * Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per Investigator assessment). * Washout periods for prior radiotherapy and chemotherapy and other systemic therapy must be followed. * Experimental anti-cancer vaccine within 2 months prior to leukapheresis in the absence of response or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months prior to leukapheresis. * Any prior gene therapy using an integrating vector. * Toxicity from previous anti-cancer therapy that has not recovered to less than or equal to (\<=)Grade 1 prior to enrollment (with exceptions). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, or other agents used in the study. * Central nervous system (CNS) metastases. * Active brain metastases or leptomeningeal metastases. * History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments. * Other active malignancies besides NSCLC within 3 years prior to Screening not in complete remission. * Unintended weight loss \>10% in 6 months preceding study entry. * Corrected QT interval (QTc) \>450 milliseconds (msec) or QTc \>480 msec for participants with Bundle Branch Block (BBB). * Uncontrolled intercurrent illness. * Participants who in the opinion of the Investigator will be unlikely to fully comply with protocol requirements. * Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphotropic virus (HTLV). * Participant is pregnant or breastfeeding. * Major surgery within 4 weeks prior to lymphodepleting chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.