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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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

Key facts

Study ID

NCT02588612

Run by

GlaxoSmithKline

People needed

10

Starts

2016-02-01

Expected to finish

2020-08-10

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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