Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 4:27 PM
Study NCT ID:
NCT06730659
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2039-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '2 years', 'description': "Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)"}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '28 days', 'description': 'The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '28 days', 'description': 'The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.'}, {'measure': 'Progress-free survival(PFS)', 'timeFrame': '2 years', 'description': 'PFS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)'}, {'measure': 'Overall survival (OS )', 'timeFrame': '3 years', 'description': 'OS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)'}, {'measure': 'pharmacokinetics (PK)', 'timeFrame': '6 months', 'description': 'Concentration levels of CD70+ CAR-T cells'}, {'measure': 'Pharmacodynamics (PD)', 'timeFrame': '6 months', 'description': 'Concentration levels of CD70 U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allogeneic CAR-T', 'Safety', 'Efficacy', 'PK'], 'conditions': ['Relapsed / Refractory Solid Tumor']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.', 'detailedDescription': '4 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and sign a written informed consent documen；\n2. At the date of signing ICF, 18 \\~70 years old, male or female；\n3. Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment；\n4. Positive CD70 expression;\n5. At least one measurable lesion at baseline per RECIST version 1.1；\n6. The expected survival time is more than 12 weeks;\n7. ECOG 0-1 points;\n8. Adequate organ functions;'}, 'identificationModule': {'nctId': 'NCT06730659', 'briefTitle': 'A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors', 'orgStudyIdInfo': {'id': 'CHT101SIIT-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHT101 infusion', 'description': 'CHT 101 will be dosing by IV.', 'interventionNames': ['Biological: CHT101']}], 'interventions': [{'name': 'CHT101', 'type': 'BIOLOGICAL', 'description': 'CHT101: CD 70 UCAR T', 'armGroupLabels': ['CHT101 infusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Yao, Ph.D', 'role': 'CONTACT', 'email': 'yaoxin1969@yahoo.com.cn', 'phone': '+86-02223340123'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Xin Yao, Ph.D', 'role': 'CONTACT', 'email': 'yaoxin1969@yahoo.com.cn', 'phone': '+86-02223340123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}