A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
Summary
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.
Arms & interventions
- OtherNo Intervention
As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
Outcome measures
Primary
Number of Participants With any Adverse Events of Special Interest (AESI)
Time frame: Up to 180 months
Secondary
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
Time frame: Up to 180 months
Overall Survival (OS)
Time frame: 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
Time frame: Up to 180 months
Eligibility criteria
Study locations (7)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Maryland Medical Center
Baltimore, Maryland, 21201
Corewell Health
Grand Rapids, Michigan, 49503
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
Swedish Cancer Institute
Seattle, Washington, 98104