No intervention
OtherAs this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
NCT Number: NCT05768269
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-This study has no exclusion criteria.
As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
Time frame: Up to 180 months
Time frame: Up to 180 months
Time frame: From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)
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.
Time frame: Up to 180 months
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.
Contact information is provided by the study sponsor or research team.
Century Therapeutics, Inc.
Industry
A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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