Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-07 @ 10:22 AM
Study NCT ID:
NCT06478251
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2024-06-23', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': '28 days post infusion', 'description': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through study completion, an average of 2 year', 'description': 'complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Through study completion, an average of 2 year', 'description': 'CR and PR, locally assessed using RECIST v1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor, Solid']}, 'descriptionModule': {'briefSummary': 'An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.', 'detailedDescription': 'Using a modified 3+3 dose escalation design, this study will enroll \\~9subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous infusion of NW-301V or NW-301D. after NW-301V or NW-301D infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. following this intervention, subjects will be monitored for safety and AE, and tumor evaluation will be performed at pre-specified timepoints per protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments\n* HLA-A\\*11:01positive\n* Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation\n* Adequate organ function prior to apheresis and lymphodepleting chemotherapy\n* ECOG performance status of 0-1\n* At least one tumor lesion measurable according to RECIST 1.1\n\n(Additional protocol-defined Inclusion criteria may apply.)\n\nKey Exclusion Criteria:\n\n* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\n* Have symptomic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Active infections with HIV, HBV, HCV, or syphilis\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Exclusion criteria may apply.)'}, 'identificationModule': {'nctId': 'NCT06478251', 'briefTitle': 'T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor', 'orgStudyIdInfo': {'id': 'NW-301-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation', 'interventionNames': ['Drug: NW-301V']}, {'type': 'EXPERIMENTAL', 'label': 'NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation', 'interventionNames': ['Drug: NW-301D']}], 'interventions': [{'name': 'NW-301V', 'type': 'DRUG', 'description': 'TCR-T cell targeting KRAS G12V mutation', 'armGroupLabels': ['NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation']}, {'name': 'NW-301D', 'type': 'DRUG', 'description': 'TCR-T cell targeting KRAS G12D mutation', 'armGroupLabels': ['NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yinan Shen, Doctor', 'role': 'CONTACT', 'email': 'fysyn@163.com', 'phone': '13486180288'}, {'name': 'Tingbo Liang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xueli Bai, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yinan Shen, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Zhejiang University school of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Rui Liu', 'role': 'CONTACT', 'email': 'rui.liu@neowisebio.com', 'phone': '0512-67991566'}, {'name': 'Yuhui He', 'role': 'CONTACT', 'email': 'yuhui.he@neowisebio.com', 'phone': '0512-67991566'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not provided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TingBo Liang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neowise Biotechnology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}