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Clinical Trial 20827

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04032847

Phase: Phase I
Prinicipal Investigator: Benjamin Creelan

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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)

Summary

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).

Objective

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

Therapies

Medications

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

Inclusion Criteria

  • Patient must be at least 18 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 evidence of CNS metastases
  • 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
  • Additional exclusion criteria may apply to define procedures within the protocol

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