An Open-Label, Multi-Center Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)
This is a first-in-human, open-label, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).
-To assess the safety and tolerability of ATL001 therapy.
-To evaluate the clinical efficacy of ATL001 using RECIST v1.1 and imRECIST.
-To evaluate the persistence, phenotype and functionality of NAR-T cells and to explore possible relationships with clinical outcomes.
-To evaluate potential biomarkers of clinical activity and factors affecting response.
-To evaluate manufacturing rate and factors that may affect the quality of ATL001.
-To evaluate the utility of a bespoke plasma ctDNA assay.
-To evaluate pleural fluid as a source of T cells and free tumor DNA.
Patients requiring regular treatment with systemic steroids
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 who are pregnant or breastfeeding
Patients who have undergone major surgery in the previous 3 weeks
Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas or non-melanomatous skin cancers)
Patients with a history of organ transplantation.
Patients who have received any investigational cell or gene therapies
Patients with contraindications for protocol specified agents
Patients with a history of immune mediated central nervous system toxicity with causal or suspected causal link to immunotherapy
Patients with a history of Grade 2 or greater diarrhea/colitis caused by previous immunotherapy within 6 months of screening. Patients that have been asymptomatic for at least 6 months or have had a normal colonoscopy post-immunotherapy (with uninflamed mucosa by visual assessment) are not excluded.
Additional exclusion criteria may apply to define procedures within the protocol
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