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).
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 intravenously in adults with advanced non-small cell lung cancer (NSCLC). 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 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
27
ATL001 infusion
Checkpoint inhibitor
Yale University School of Medicine
New Haven, Connecticut, United States
Assessment of Treatment Emergent Adverse Events (TEAEs) to Evaluate Safety and Tolerability
Evaluate TEAEs and serious AEs, by incidence, severity and relationship to ATL001
Time frame: 62 months due to early termination
Disease Assessment for Change From Baseline in Tumour Size
Evaluate the clinical activity of ATL001 in patients with advanced NSCLC 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 Time to Response (TTR) From ATL001 Infusion
Evaluate the endpoint of TTR 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 Objective Response Rate (ORR)
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 62 months due to early termination)
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Moffitt Cancer Center
Tampa, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, Spain
Centro Integral Oncologico Clara Campal Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
...and 9 more locations
Disease Assessment for Duration of Response (DoR). The DoR is Defined as the Time From the Date of First Documented Response Until the Date of Documented Disease Progression or Death
Evaluate the endpoint of DOR 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 Disease Control Rate (DCR)
Evaluate the endpoints of 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 (PFS)
Evaluate the efficacy endpoints of 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 (OS)
Evaluate OS by the investigator
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months