A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product

Study Overview
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Brief Summary
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This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.

Official Title
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A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product

Conditions
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Hematological Malignancy, Solid Tumor Malignancy

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures. Participants received at least one treatment with a cellular therapy product in an eligible index trial. Participant was withdrawn, early discontinued or completed an eligible index trial. Participant is willing and able to comply with scheduled visits, study plan, and other study procedures. Exclusion Criteria: -This study has 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cellular Therapy<br>Participants who have previously received an induced pluripotent stem cell (iPSC)-derived, ex vivo genome edited cellular therapy product in an eligible Century-sponsored index trial will be enrolled in this study for up to 180 months following the last treatment with a cellular therapy product in an eligible index trial. | Other: No Intervention<br>* As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With any Adverse Events of Special Interest (AESI) |  | Up to 180 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cellular Product-related Serious Adverse Events (SAEs) |  | Up to 180 months | 
| Overall Survival (OS) | OS is defined as the time from first treatment with a cellular therapy product in the index trial to date of death by any cause. | From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months) | 
| Percentage of Participants With Persistent Product | Persistence of the cellular product will be assessed by a droplet digital polymerase chain reaction molecular test to evaluate transgene copies in the peripheral blood. Summary of persistence sample results (positive/negative) will be reported. | Up to 180 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Century Therapeutics, Cellular Therapy, Cell therapy, Malignancy