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ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT04032847
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Achilles Therapeutics Ltd

Brief Summary:
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 (cNeTs) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Biological: ATL001 Phase 1 Phase 2

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 (cNeTs) 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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1
Infusion of cell therapy product ATL001.
Biological: ATL001
ATL001 infusion




Primary Outcome Measures :
  1. Assessment of Treatment Emergent Adverse Events to evaluate Safety and Tolerability [ Time Frame: 84 months ]
    Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001


Secondary Outcome Measures :
  1. 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 ]
    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)


Other Outcome Measures:
  1. Disease Assessment for Objective Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoint of objective response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST).

  2. Disease Assessment for Time to Response from ATL001 infusion [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoint of time to response by the investigator and ICR, per RECIST v1.1 and im-RECIST

  3. Disease Assessment for Duration of Response (DoR). The DoR is defined as the time from the date of first documented response until the date of documented disease progression or death [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoint of duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST

  4. Disease Assessment for Disease Control Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoints of disease control rate (DCR) as assessed by the the investigator and ICR per RECIST v1.1 and im-RECIST

  5. Disease Assessment for Progression-Free Survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST

  6. Overall Survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate overall survival (OS) by the investigator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032847


Contacts
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Contact: Shree Patel, PhD +44 (0)1438 906 855 info@achillestx.com

Locations
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United Kingdom
University College London Hospital (UCLH) Recruiting
London, United Kingdom, NW12PG
Contact: Martin Forster, MD    + 44 (0) 2034475085    m.forster@ucl.ac.uk   
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Alastair Greystoke, MD    0191 213 9398    alastair.greystoke@ncl.ac.uk   
Sponsors and Collaborators
Achilles Therapeutics Ltd

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Responsible Party: Achilles Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT04032847     History of Changes
Other Study ID Numbers: ATX-NS-001
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms