A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentury Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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Participant was withdrawn, early discontinued or completed an eligible index trial.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.
Disqualifiers
None
Trial population
Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionAs this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
Treatment groups
375 Participants
are divided into 1 treatment groupGroup A: Cellular Therapy1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With any Adverse Events of Special Interest (AESI)
Time frame
Up to 180 monthsSecondary outcomes
1
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
Time frame
Up to 180 months2
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.
Time frame
From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)3
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.
Time frame
Up to 180 monthsSponsors and contacts
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Source ClinicalTrials.gov