Clinical Trials /

ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

NCT04032847

Description:

This is a first-in-human, open-label, multi-centre, 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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
  • Official Title: An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: ATX-NS-001
  • NCT ID: NCT04032847

Conditions

  • Advanced Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ATL001Arm 1

Purpose

This is a first-in-human, open-label, multi-centre, 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).

Detailed Description

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

      Patients will initially enter the study for procurement of starting materials to manufacture
      ATL001.

      Following manufacture of ATL001, the product will be given back to eligible patients
      following lymphodepletion. Patients will be followed up for a period of 24 months post ATL001
      infusion. Patients will then be requested to enter a separate long term follow up protocol
      for a further 5 years (total 84 months)
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalInfusion of cell therapy product ATL001.
  • ATL001

Eligibility Criteria

        Inclusion Criteria:

          1. Patient must be at least 18 years old

          2. Patient must have given written informed consent

          3. Confirmed diagnosis of non-small cell lung cancer

          4. ECOG Performance status 0-1

          5. Anticipated life expectancy ≥ 6 months

          6. Measurable disease according to RECIST 1.1 criteria

          7. Adequate organ function

          8. Patient is considered medically fit to undergo procurement of starting material and
             ATL001 administration procedures

          9. Patient is considered, in the opinion of the investigator, capable of adhering to the
             protocol.

         10. If female, patient must be either postmenopausal, sterilised or, if sexually active,
             effectively practicing a highly effective method of contraception.

         11. Male patients agree to ensure that they or their female partner(s) use a highly
             effective method of contraception during the study

         12. Patients must have measurable disease according to RECIST v1.1

        Exclusion Criteria:

          1. Patients with evidence of CNS metastases

          2. Patients with active infectious disease

          3. Patients who are non-smokers

          4. Patients requiring immunosuppressive treatments.

          5. Patients requiring regular treatment with systemic steroids

          6. Patients with superior vena cava syndrome

          7. Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic,
             haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological
             disease

          8. Patients who are pregnant or breastfeeding

          9. Patients who have undergone major surgery in the previous 3 weeks

         10. 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)

         11. Patients with a history of organ transplantation.

         12. Patients who have received any investigational cell or gene therapies

         13. Patients with contraindications for protocol specified agents

        Additional exclusion criteria may apply to define procedures within the protocol
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assessment of Treatment Emergent Adverse Events to evaluate Safety and Tolerability
Time Frame:84 months
Safety Issue:
Description:Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001

Secondary Outcome Measures

Measure:Disease Assessment for Change from Baseline in Tumour Size
Time Frame:Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Safety Issue:
Description:Evaluate the clinical activity of ATL001 in patients with advanced NSCLC using change from baseline in tumour size at week 6 , week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Achilles Therapeutics Ltd

Last Updated

January 20, 2020