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Trial Title:
A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product
NCT ID:
NCT05768269
Condition:
Hematological Malignancy
Solid Tumor Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Century Therapeutics
Cellular Therapy
Cell therapy
Malignancy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No Intervention
Description:
As this is a non-interventional rollover, long-term safety follow-up study, no
intervention will be administered.
Arm group label:
Cellular Therapy
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.
Criteria for eligibility:
Study pop:
Participants who have been previously treated with cellular therapy products in an
eligible investigational index trial.
Sampling method:
Non-Probability Sample
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- Participant was withdrawn, early discontinued or completed an eligible index trial.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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dr Moyo
Phone:
980-442-2301
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dr Latif
Phone:
513-584-7824
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dr. Krish Patel
Phone:
206-991-2040
Email:
krish.patel@swedish.org
Start date:
April 29, 2024
Completion date:
March 2040
Lead sponsor:
Agency:
Century Therapeutics, Inc.
Agency class:
Industry
Source:
Century Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768269
