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 with known central nervous system metastases that are untreated or symptomatic or progressing.
Patients with active infectious disease
Patients who are non-smokers
Patients requiring immunosuppressive treatments.
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 following discontinuation of immune suppression other than permitted modified release steroids) are not excluded.
Patients wuth confirmed history of allergic reactions to amphotericin b, penicillin and/or streptomycin
Additional exclusion criteria may apply to define procedures within the protocol
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