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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513060-26-00
Acronym
ATX-NS-001
Enrollment
24
Registered
2024-06-03
Start date
2021-04-07
Completion date
2024-09-17
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Brief summary

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) following tissue procurement and administration of lymphodepletion agents, ATL001 (monotherapy or in combination with pembrolizumab) and IL-2.

Detailed description

Percentage change from baseline in tumour size at 6 weeks, 12 weeks and best change from baseline, Overall Response Rate (ORR) (based on RECIST v1.1 and imRECIST), Time to response (based on RECIST v1.1 and imRECIST), Duration of response (based on RECIST v1.1 and imRECIST), Disease Control Rate (CR + PR + durable SD) (based on RECIST v1.1), Progression free survival (PFS) (based on RECIST v1.1 and imRECIST), Overall survival (OS)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGATL001

Sponsors

Achilles Therapeutics UK Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) following tissue procurement and administration of lymphodepletion agents, ATL001 (monotherapy or in combination with pembrolizumab) and IL-2.

Secondary

MeasureTime frame
Percentage change from baseline in tumour size at 6 weeks, 12 weeks and best change from baseline, Overall Response Rate (ORR) (based on RECIST v1.1 and imRECIST), Time to response (based on RECIST v1.1 and imRECIST), Duration of response (based on RECIST v1.1 and imRECIST), Disease Control Rate (CR + PR + durable SD) (based on RECIST v1.1), Progression free survival (PFS) (based on RECIST v1.1 and imRECIST), Overall survival (OS)

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026