Hematological Malignancy, Solid Tumor Malignancy
Conditions
Keywords
Century Therapeutics, Cellular Therapy, Cell therapy, Malignancy
Brief 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.
Interventions
OTHERNo Intervention
As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
Sponsors
Century Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Participant was withdrawn, early discontinued or completed an eligible index trial.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With any Adverse Events of Special Interest (AESI) | Up to 180 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cellular Product-related Serious Adverse Events (SAEs) | Up to 180 months | — |
| Overall Survival (OS) | 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. |
| Percentage of Participants With Persistent Product | 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. |
Countries
United States
Contacts
Primary ContactCentury Therapeutics Clinical Team
Outcome results
None listed