Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04803058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2021-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2021-03-14', 'studyFirstSubmitQcDate': '2021-03-14', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance', 'timeFrame': '24 months', 'description': 'The proportion of patients off immunosuppression with good safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Incidence of biopsy proven acute rejection, death, and graft loss', 'timeFrame': '24 months'}, {'measure': 'The incidence of DSA', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand the study requirements and provide written informed consent before any study assessment is performed\n* Male or female patients ≥ 18 to 65 years of age\n* Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor\n\nKey Exclusion Criteria:\n\n* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol\n* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix\n* Recipient with anti-HLA donor-specific antibody (DSA)'}, 'identificationModule': {'nctId': 'NCT04803058', 'acronym': 'PERSPECTIVE', 'briefTitle': 'A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ITB-Med LLC'}, 'officialTitle': 'A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation', 'orgStudyIdInfo': {'id': 'TCD601A202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'TCD601administered with non-myeloablative conditioning and standard of care immunosuppression', 'interventionNames': ['Biological: TCD601']}], 'interventions': [{'name': 'TCD601', 'type': 'BIOLOGICAL', 'description': 'Investigational Product', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Tracy Killingsworth', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nefro Avillion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ITB-Med LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}