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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematological Malignancy; Solid Tumor Malignancy
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 375

Contacts and Locations

• Study Contact: Name: Century Therapeutics Clinical Team; Phone Number: 8885067670; Email: trial_response_century@centurytx.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Not yet recruiting
      • Banner MD Anderson Cancer Center
      • Contact: Dr Matthew Ulrickson; Phone Number: 480-256-6444
  • California
    • Los Angeles, California, United States, 90033
      • Not yet recruiting
      • University of Southern California - Norris Comprehensive Cancer Center
      • Contact: Dr Yaghmour; Phone Number: 323-865-3170
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
      • Contact: Dr Nancy Hardy; Phone Number: 410-328-1230; Email: nhardy1@umm.edu
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Not yet recruiting
      • Corewell Health
      • Contact: Dr Sami Brake; Phone Number: 616-486-5933; Email: sami.brake@corewellhealth.org
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Contact: Dr Moyo; Phone Number: 980-442-2301
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • University of Cincinnati Medical Center
      • Contact: Dr Latif; Phone Number: 513-584-7824
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Cancer Institute
      • Contact: Dr. Krish Patel; Phone Number: 206-991-2040; Email: krish.patel@swedish.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cellular Therapy; 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.	Other: No Intervention; As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With any Adverse Events of Special Interest (AESI)	Up to 180 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)		Up to 180 months
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.	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	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.	Up to 180 months

Collaborators and Investigators

• Sponsor: Century Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): March 1, 2040
• Study Completion (Estimated): March 1, 2040

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cell therapy; Malignancy; Cellular Therapy; Century Therapeutics
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: CNTY-LTFU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No