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

Study Identifier:
ATX-NS-001
CT.gov Identifier:
NCT04032847
EudraCT Identifier:
2018-001005-85
EU Trial (CTIS) Number:
2024-513060-26-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate safety and efficacy of clonal neoantigen T cells (cNeT) in patients with advanced NSCLC.

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).

Correlative studies will investigate the effects of cNeT dose and engraftment kinetics on clinical activity.

To evaluate safety, tolerability and activity, biomarkers of clinical activity and bespoke ctDNA assay

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unmapped
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18 - 100 Years
Study Drug
Drug: Experimental: Cohort A
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Drug: Experimental: Cohort B
Drug: Drug: Pembrolizumab
Drug: Experimental: Cohort C
Drug: Routes of administration: Intravenous use
Drug: Patients will initially enter the study for procurement of starting materials to manufacture ATL001.
Drug: 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)
Drug: ASCO 2021:
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • Patient must be at 18-75 years old.
  • Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related.
  • Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
  • ECOG Performance Status 0-1.
  • Adequate organ function per the laboratory parameters defined in the protocol.
  • Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
  • Measurable disease according to RECIST 1.1 criteria.
Exclusion criteria
  • Patients with untreated, symptomatic or progressing CNS metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids.
  • Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection.
  • Patients for whom there is documented evidence of an actionable tumour driver oncogene mutation (EGFR, ALK or ROS-1) at the time of initial screening. Patients who have progressed on standard targeted therapies, or for whom no approved targeted treatments are available, are not excluded.
  • Patients requiring immunosuppressive treatments.
  • Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent)
  • 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 with a history of immune mediated central nervous system toxicity, or a history of ≥ Grade 2 diarrhoea/colitis within the past 6 months caused by previous immunotherapy.
  • Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate- Specific Antigen (PSA) or non-melanomatous skin cancers)
  • Patients with a history of organ transplantation
  • Patients who have previously received any investigational cell or gene therapies

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Maria de Miguel
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Unmapped