Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT05987527
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2039-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival'}, {'measure': 'Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.'}], 'secondaryOutcomes': [{'measure': 'Long term graft related outcomes', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidence of graft rejection according to the Banff classification criteria'}, {'measure': 'Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Number of in-patient days in hospital'}, {'measure': 'Incidence of Adverse Events related to TX200-TR101 over a long term period', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidence of Adverse Events related to TX200-TR101'}, {'measure': 'Incidence of Adverse Events of special interest as defined in the protocol over long term', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidence of Adverse Events of special interest as defined in the protocol'}, {'measure': 'Change in immunosuppression regime to evaluate long term safety of TX200-TR101', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Change in immunosuppression regime'}, {'measure': 'Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidence of graft loss due to rejection'}, {'measure': 'Incidents of deaths to evaluate composite efficacy profile of TX200-TR101', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidences of death of TX200-TR101 participants'}, {'measure': 'Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101', 'timeFrame': 'Up to 15 years post infusion', 'description': 'Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regulatory T-Cells', 'Genetically modified cells', 'Chimeric antigen receptor', 'Long term follow up', 'T-Regs', 'Cell Therapy'], 'conditions': ['Kidney Transplant Rejection', 'End Stage Renal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT04817774?term=TX200-KT02&draw=2&rank=1', 'label': 'Link to parent study STEADFAST, TX200-KT02'}]}, 'descriptionModule': {'briefSummary': 'This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.', 'detailedDescription': 'This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.\n\nThe aim is for this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.\n2. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05987527', 'briefTitle': 'Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sangamo Therapeutics'}, 'officialTitle': 'Long-Term Follow-Up of Patients Who Have Received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg Therapy, TX200-TR101) in a Prior Clinical Study', 'orgStudyIdInfo': {'id': 'TX200-KT03'}, 'secondaryIdInfos': [{'id': '2022-002440-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation\n\nAssigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02', 'interventionNames': ['Diagnostic Test: Blood sample']}, {'label': 'Control group', 'description': 'Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered', 'interventionNames': ['Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine procedures', 'armGroupLabels': ['Control group', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Centre', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC, University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sangamo Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}