Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-01 @ 4:16 PM
Study NCT ID:
NCT06941350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event(AE) or Serious Adverse Event(SAE)', 'timeFrame': '100 days after first administration of NCR102 injection', 'description': 'Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'ORR at Day 28', 'timeFrame': '28 days after first dose administration', 'description': 'Overall Response Rate(ORR) at Day 28'}, {'measure': 'CRR at Day 28', 'timeFrame': '28 days after first dose administration', 'description': 'Complete Response Rate(CRR) at Day 28'}, {'measure': 'ORR at Day 56', 'timeFrame': '56 days after first dose administration', 'description': 'Overall Response Rate(ORR) at Day 56'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SR-aGVHD', 'NCR102', 'second-line treatment failure'], 'conditions': ['Acute Graft-versus-Host Disease']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.', 'detailedDescription': 'An open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years and \\<70 years old (including threshold), gender not limited；\n* Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；\n* Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；\n* Failed to second-line aGVHD treatment;\n* Subjects will receive NCR102 injection treatment within 3 days after enrollment;\n* Voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* Subjects have lung disease, and investigators have determined that they are not suitable for the study;\n* Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;\n* Subjects with signs/symptoms of chronic GVHD;\n* Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;\n* Eastern Cooperative Oncology Group(ECOG)\\>3；\n* Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；\n* Subjects had active malignant solid tumors within the past 5 years；\n* Subjects had a known history of severe allergies to blood products, or heterologous proteins.'}, 'identificationModule': {'nctId': 'NCT06941350', 'briefTitle': 'A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuwacell Biotechnologies Co., Ltd.'}, 'officialTitle': 'A Phase I/II Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)', 'orgStudyIdInfo': {'id': 'NCR102-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NCR102 injection', 'description': 'Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection', 'interventionNames': ['Biological: NCR102 injection']}], 'interventions': [{'name': 'NCR102 injection', 'type': 'BIOLOGICAL', 'description': 'Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.', 'armGroupLabels': ['NCR102 injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yanqiu Li', 'role': 'CONTACT', 'email': 'yqli@nuwacell.com', 'phone': '400-888-2032'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuwacell Biotechnologies Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}