ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Achilles Therapeutics UK Limited
Study ID
NCT04032847
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ATL001 — BIOLOGICAL
    ATL001 infusion
  • Pembrolizumab — DRUG
    Checkpoint inhibitor

Study Details

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).

Key Dates

Start date
Jul 8, 2019
Status verified
Feb 2025
Primary completion
Sep 26, 2024
Completion
Sep 26, 2024

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.
  • Experimental: Cohort B
    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.
  • Experimental: Cohort C
    Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.

Primary Outcome Measure

Assessment of Treatment Emergent Adverse Events (TEAEs) to Evaluate Safety and Tolerability [ Time Frame: 62 months due to early termination ]

Locations (3)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10017-

Related coverage on Hipa.ai

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By research site
Yale University School of Medicine· New Haven, CTMoffitt Cancer Center· Tampa, FLMemorial Sloan Kettering Cancer Center· New York, NY

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