Clinical trial · Interventional
ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
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
NCT04032847CI-TRIAL-00086947terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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 in adults with advanced non-small cell lung cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATL001 | Biological | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.
- interventionNames
- Biological: ATL001
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL- 2.
- interventionNames
- Biological: ATL001
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Cohort C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must be at 18-75 years old. 2. Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related. 3. Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures. 4. ECOG Performance Status 0-1. 5. Adequate organ function per the laboratory parameters defined in the protocol. 6. Anticipated life expectancy ≥ 6 months at the time of tissue procurement. 7. Measurable disease according to RECIST 1.1 criteria. Additional Inclusion Criteria will apply as per the protocol. Exclusion Criteria: 1. 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. 2. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection. 3. 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. 4. Patients requiring immunosuppressive treatments. 5. Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent) 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 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. 9. 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) 10. Patients with a history of organ transplantation 11. Patients who have previously received any investigational cell or gene therapies Additional Exclusion Criteria will apply as per the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.