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

Century Therapeutics, Inc.7 sites in 1 country375 target enrollmentApril 29, 2024

ConditionsHematological Malignancy Solid Tumor Malignancy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hematological Malignancy
Sponsor: Century Therapeutics, Inc.
Enrollment: 375
Locations: 7
Primary Endpoint: Number of Participants With any Adverse Events of Special Interest (AESI)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2024

End Date

March 1, 2040

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Century Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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•Participant was withdrawn, early discontinued or completed an eligible index trial.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.

Outcomes

Primary Outcomes

Number of Participants With any Adverse Events of Special Interest (AESI)

Time Frame: Up to 180 months

Secondary Outcomes

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))
Percentage of Participants With Persistent Product(Up to 180 months)