Status:
TERMINATED
ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
Lead Sponsor:
Achilles Therapeutics UK Limited
Conditions:
Advanced Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 reactive T cells (cNeT) administered intravenously i...
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 reactive T cells (cNeT) administered intravenousl...
Eligibility Criteria
Inclusion
- 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.
- Additional Inclusion Criteria will apply as per the protocol.
Exclusion
- 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
- Additional Exclusion Criteria will apply as per the protocol.
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04032847
Start Date
July 8 2019
End Date
September 26 2024
Last Update
March 10 2025
Active Locations (19)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
4
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310