Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-05 @ 2:07 PM
Study NCT ID:
NCT06954558
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '2 years', 'description': 'The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).'}], 'secondaryOutcomes': [{'measure': 'PK', 'timeFrame': '2 years', 'description': 'Levels of T-cell Receptor copies'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years'}, {'measure': 'Progress-free survival(PFS)', 'timeFrame': '2 years', 'description': 'PFS will be assessed from the first GK01 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)'}, {'measure': 'Overall survival (OS )', 'timeFrame': '2 years', 'description': 'OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '2 years'}, {'measure': 'Patient Quality of Life', 'timeFrame': '2 years', 'description': 'EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)'}, {'measure': 'PD marker', 'timeFrame': '2 years', 'description': 'Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['efficacy', 'safety', 'PK', 'TILs'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Ability to understand and sign a written informed consent document；\n2. At the date of signing ICF, 18 \\~70 years old, male or female；\n3. Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment；\n4. There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies;\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': 'NCT06954558', 'acronym': 'GUARDIAN', 'briefTitle': 'A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GK01IIT-TZ01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GK01 injection', 'description': 'Autologous tumor-reactive T cells injection', 'interventionNames': ['Drug: GK01 Injection']}], 'interventions': [{'name': 'GK01 Injection', 'type': 'DRUG', 'description': 'Autologous tumor-reactive T cells injection', 'armGroupLabels': ['GK01 injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jihui Hao', 'role': 'CONTACT', 'email': 'haojihui@tjmuch.com', 'phone': '+86-02223340123'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jihui Hao', 'role': 'CONTACT', 'email': 'haojihui@tjmuch.com', 'phone': '+86-02223340123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Geek Gene Technology Co., LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}