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

NCT05768269 | Recruiting

• 1 other identifier: CNTY-LTFU-01
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 7

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.

Conditions

Hematological Malignancy; Solid Tumor Malignancy

Keywords

Century Therapeutics; Cellular Therapy; Cell therapy; Malignancy

Outcome Measures

Primary Outcomes (1)

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

  Up to 180 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

No Intervention OTHER

As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.

Cellular Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Century Therapeutics, Inc.: lead

Study Sites (7)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

NOT YET RECRUITING

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

NOT YET RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Century Therapeutics Clinical Team

CONTACT

8885067670; trial_response_century@centurytx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 14, 2023
• Study Start: April 29, 2024
• Primary Completion (Estimated): March 1, 2040
• Study Completion (Estimated): March 1, 2040
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)