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

Hematological Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768269
• Other study ID #: CNTY-LTFU-01
• Status: Recruiting
• Start date: April 29, 2024
• Est. completion date: March 2040

Study information

• Verified date: May 2024
• Source: Century Therapeutics, Inc.
• Contact: Nikolaus Trede, MD
• Phone: 888-688-0644
• Email: ClinicalTeamCNTY[@]centurytx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: March 2040
• Est. primary completion date: March 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Participant was withdrawn, early discontinued or completed an eligible index trial.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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms
• Solid Tumor Malignancy

Intervention

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

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Century Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With any Adverse Events of Special Interest (AESI)		Up to 180 months
Secondary	Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)		Up to 180 months
Secondary	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)
Secondary	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