Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
Checked against the public recordLast updated Sep 5, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- GlaxoSmithKline
- Interventions being studied
- Drug: letetresgene autoleucel (GSK3377794); Drug: Cyclophosphamide; Drug: Fludarabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- GSK Investigational SiteMiami, Florida
- GSK Investigational SiteTampa, Florida
- GSK Investigational SiteHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 5, 2021. Always confirm current availability with the study team.