Clinical trial NCT05768269: A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product
Official title: A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematological Malignancy
Solid Tumor Malignancy
Keywords: Century Therapeutics
Cellular Therapy
Cell therapy
Malignancy
Lead sponsor: Century Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.

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.


Eligibility criteria: 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* Participant was withdrawn, early discontinued or completed an eligible index trial.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.

Primary outcomes:
measure: Number of Participants With any Adverse Events of Special Interest (AESI)
timeFrame: Up to 180 months
Secondary outcomes:
measure: Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
timeFrame: Up to 180 months
measure: Overall Survival (OS)
timeFrame: From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)
measure: Percentage of Participants With Persistent Product
timeFrame: Up to 180 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California - Norris Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
References: