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).
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
Drug | Synonyms | Arms |
---|
ATL001 | | Cohort A |
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 tumour materials required 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 in the study. Patients will then be requested to enter a separate long term follow
up protocol for a further 5 years (total 84 months)
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A | Experimental | Infusion of cell therapy product ATL001. | |
Cohort B | Experimental | Infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor | |
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 that is considered to be smoking
related
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
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
14. 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
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, 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 UK Limited |
Last Updated
February 16, 2021