This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma. 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 continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
ATL001 infusion
Nivolumab
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, Spain
Centro Integral Oncologico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
Madrid, Spain
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, United Kingdom
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE
Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001
Time frame: 60 months due to early termination
Disease Assessment for Change From Baseline in Tumour Size
Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma 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).
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Overall Response Rate
Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy.
Time frame: Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination)
Disease Assessment for Time to Response and Duration of Response
Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital
London, United Kingdom
Royal Free London NHS Foundation Trust, Royal Free Hospital
London, United Kingdom
Guys and St Thomas' NHS Foundation Trust, Guy's Hospital
London, United Kingdom
The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital
London, United Kingdom
The Christie NHS Foundation Trust, Christie Hospital
Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton General Hospital
Southampton, United Kingdom
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Disease Control Rate
Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Disease Assessment for Progression-Free Survival
Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Overall Survival
Evaluate overall survival (OS) by investigator
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months