Long-Term Follow-Up Study of Patients Receiving ATL001

Study Overview
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Brief Summary
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This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).

Detailed Description
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Up to 90 patients with advanced non-small cell lung cancer ( NSCLC) or metastatic or recurrent melanoma will be enrolled after either: completing 2 years of follow-up visits in study ATX-NS-001 or study ATX-ME-001; or voluntary withdrawal from these studies prior to the completion of the 2 year of follow-up period. Each patient will be followed up for a minimum period of 5 years, or until death if sooner, in this Long-Term Follow Up Protocol. For patients who are still alive after 5 years of follow-up, survival data will continue to be collected until the end of the study, which will occur when the last patient has completed 5 years of follow-up withdraws from study or has died.

Official Title
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An Open-Label, Multi-Centre Phase II Study Evaluating the Long-Term Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients Who Have Previously Received ATL001 in a Clinical Trial

Conditions
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Melanoma, Advanced Non Small Cell Lung Cancer

Intervention / Treatment
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* Other: Biological: ATL001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have given written informed consent to participate in the study. Patients must have received ATL001 in a previous Clinical Trial. Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental: ATL001<br>Patients who have previously received ATL001 in a clinical trial will be evaluated in this trial for long-term safety and clinical activity. | Other: Biological: ATL001<br>* No investigational product will be administered<br>|
| Other: Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001<br>Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001 | Other: Biological: ATL001<br>* No investigational product will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001 | Evaluate the frequency and severity of adverse events related or possibly related to ATL001 | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. | 
| Assessment of autoimmune adverse events | Evaluate the frequency and severity of autoimmune adverse events | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. | 
| Assessment of new malignancies | Evaluate the frequency and severity of new malignancies | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. | 
| Assessment of the use of medications to manage ATL001-related toxicities | Evaluate the use of medications to manage ATL001-related toxicities | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Assessment for Duration of Response ( DoR) | Evaluate the endpoint of DoR as assessed by the Investigator and Independent Central Review (ICR), per RECIST v1.1 | Maximum 60 months. | 
| Disease Assessment for Progression Free Survival (PFS) | Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1 | Maximum 60 months. | 
| Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST) | Evaluate the endpoint of TFST | Maximum 60 months. | 
| Assessment for Overall Survival (OS) | Evaluate the endpoint of OS by the Investigator | 6 months until death or until the end of the study, whichever came first, assessed up to 84 months | 
| Assessment for cancer-related medical resources | Evaluate the endpoint of cancer-related medical resourcesATL001 therapy | Maximum 60 months. |