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Recruiting

NCT Number: NCT05768269

A Study for Participants Previously Treated With 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Participant was withdrawn, early discontinued or completed an eligible index trial.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

Treatment and study plan

No intervention

Other

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

Primary outcomes

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

    Time frame: Up to 180 months

Secondary outcomes

  1. Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)

    Time frame: Up to 180 months

  2. Overall Survival (OS)

    Time frame: 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.

  3. Percentage of Participants With Persistent Product

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Century Therapeutics Clinical Team

CONTACT

[email protected]

8885067670

Sponsors and collaborators

Lead sponsor

Century Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2040
Study completion
2040
First posted
Mar 14, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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