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

Sponsor

Century Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05768269

Collaborator

(none)

375

Enrollment

192

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancy Solid Tumor Malignancy	Other: No Intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

375 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Mar 1, 2040

Anticipated Study Completion Date :

Mar 1, 2040

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Number of Participants With any Adverse Events of Special Interest (AESI) [Up to 180 months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Century Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Century Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05768269

Other Study ID Numbers:

CNTY-LTFU-01

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Century Therapeutics, Inc.

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Mar 14, 2023