A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product

Recruiting

• Conditions: Hematological Malignancy; Solid Tumor Malignancy
• Interventions: Other: No Intervention

• Registration Number: NCT05768269
• Lead Sponsor: Century Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-14
• Study Start: 2024-04-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2040-03
• Study Completion: 2040-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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• Participant was withdrawn, early discontinued or completed an eligible index trial.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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cellular Therapy	No Intervention	Participants who have previously received an induced pluripotent stem cell (iPSC)-derived, ex vivo genome edited cellular therapy product in an eligible Century-sponsored index trial will be enrolled in this study for up to 180 months following the last treatment with a cellular therapy product in an eligible index trial.

Primary Outcome Measures

Name	Time	Method
Number of Participants With any Adverse Events of Special Interest (AESI)	Up to 180 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

University of Southern California - Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States