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  • Cancer Type: Thoracic
  • Study Type: Treatment
  • NCT#: NCT04032847
  • Phase: Phase I
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  • Overview

    Study Title:

    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).


    Primary Objective: -To assess the safety and tolerability of ATL001 therapy. Secondary Objective: -To evaluate the clinical efficacy of ATL001 using RECIST v1.1 and imRECIST. Exploratory Objectives: -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.

  • Treatments


    Cell Therapy; Chemotherapy (NOS); Immunotherapy; Therapy (NOS)


    ATL001 (); IL-2 (Interleukin-2); Pembrolizumab (Keytruda); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

  • Inclusion Criteria

    • Patient must be between 18 and 75 years old
    • Patient must have given written informed consent
    • Confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related
    • ECOG Performance status 0-1
    • Anticipated life expectancy > 6 months
    • Measurable disease according to RECIST 1.1 criteria
    • Adequate organ function
    • Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures
    • Patient is considered, in the opinion of the investigator, capable of adhering to the protocol.
    • If female, patient must be either postmenopausal, sterilised or, if sexually active, effectively practicing a highly effective method of contraception.
    • Male patients agree to ensure that they or their female partner(s) use a highly effective method of contraception during the study
  • Exclusion Criteria

    • Patients with known central nervous system metastases that are untreated or symptomatic or progressing. Lesions should be clinically and radiologically stable for 2 months after treatment, as determined by MRI or CT evaluation, in line with accepted standard of care procedures, and should not require steroids.
    • 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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