ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

Inclusion Criteria

• Patient must be at 18-75 years old.
• Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related.
• Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
• ECOG Performance Status 0-1.
• Adequate organ function per the laboratory parameters defined in the protocol.
• Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
• Measurable disease according to RECIST 1.1 criteria. Additional Inclusion Criteria will apply as per the protocol.

Exclusion Criteria

• Patients with untreated, symptomatic or progressing CNS metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids.
• Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection.
• Patients for whom there is documented evidence of an actionable tumour driver oncogene mutation (EGFR, ALK or ROS-1) at the time of initial screening. Patients who have progressed on standard targeted therapies, or for whom no approved targeted treatments are available, are not excluded.
• Patients requiring immunosuppressive treatments.
• Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent)
• Patients with superior vena cava syndrome.
• Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
• Patients with a history of immune mediated central nervous system toxicity, or a history of ≥ Grade 2 diarrhoea/colitis within the past 6 months caused by previous immunotherapy.
• Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate- Specific Antigen (PSA) or non-melanomatous skin cancers)
• Patients with a history of organ transplantation
• Patients who have previously received any investigational cell or gene therapies Additional Exclusion Criteria will apply as per the protocol.