ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

About the study

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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.