Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT05768269
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2040-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With any Adverse Events of Special Interest (AESI)', 'timeFrame': 'Up to 180 months'}], 'secondaryOutcomes': [{'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)', 'description': '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.'}, {'measure': 'Percentage of Participants With Persistent Product', 'timeFrame': 'Up to 180 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Century Therapeutics', 'Cellular Therapy', 'Cell therapy', 'Malignancy'], 'conditions': ['Hematological Malignancy', 'Solid Tumor Malignancy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have been previously treated with cellular therapy products in an eligible investigational index trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.\n* Participants received at least one treatment with a cellular therapy product in an eligible index trial.\n* Participant was withdrawn, early discontinued or completed an eligible index trial.\n* Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.\n\nExclusion Criteria:\n\n-This study has no exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05768269', 'briefTitle': 'A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Century Therapeutics, Inc.'}, 'officialTitle': 'A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product', 'orgStudyIdInfo': {'id': 'CNTY-LTFU-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cellular Therapy', 'description': '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.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.', 'armGroupLabels': ['Cellular Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Matthew Ulrickson', 'role': 'CONTACT', 'phone': '480-256-6444'}], 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Yaghmour', 'role': 'CONTACT', 'phone': '323-865-3170'}], 'facility': 'University of Southern California - Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Nancy Hardy', 'role': 'CONTACT', 'email': 'nhardy1@umm.edu', 'phone': '410-328-1230'}], 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Sami Brake', 'role': 'CONTACT', 'email': 'sami.brake@corewellhealth.org', 'phone': '616-486-5933'}], 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Moyo', 'role': 'CONTACT', 'phone': '980-442-2301'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Latif', 'role': 'CONTACT', 'phone': '513-584-7824'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Krish Patel', 'role': 'CONTACT', 'email': 'krish.patel@swedish.org', 'phone': '206-991-2040'}], 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Century Therapeutics Clinical Team', 'role': 'CONTACT', 'email': 'trial_response_century@centurytx.com', 'phone': '8885067670'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Century Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}