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Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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)

NCT02588612•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.

Detailed Description

New York esophageal antigen-1 (NY-ESO-1) and L antigen family member (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 engineered TCR T-cells. This protocol investigates letetresgene autoleucel treatment in Human Leukocyte Antigen (HLA)\*-A\*02+ participants with NY-ESO1+ advanced metastatic non-small cell lung cancer as second line treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+7 more criteria

Locations (3)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Houston, Texas, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

August 10, 2020

Completion Date

August 10, 2020

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

letetresgene autoleucel (GSK3377794)

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

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