Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 7:21 AM
Study NCT ID:
NCT07123493
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Engineered T-Cell Therapy for Patients With ALPP-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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months'}, {'measure': 'Tmax of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months'}, {'measure': 'AUC0-last of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months'}, {'measure': 'Clast of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months'}, {'measure': 'Tlast of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months'}, {'measure': 'To assess ALPP CAR-T cell trafficking into tumor tissues following infusion【To detect ALPP CAR-T cell number in tumor tissues after infusion】', 'timeFrame': 'Up to 24 months'}], 'primaryOutcomes': [{'measure': 'Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]', 'timeFrame': 'Up to 24 months', 'description': 'The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.'}, {'measure': 'Incidence of Dose Limiting Toxicity of ALPP CAR-T cells [Safety and Tolerability]', 'timeFrame': 'Up to 1 month', 'description': 'Incidence of Dose Limiting Toxicity'}], 'secondaryOutcomes': [{'measure': 'Efficacy of ALPP CAR-T cells', 'timeFrame': 'Up to 24 months', 'description': 'Optimal objective response rate (ORR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T', 'Recurrent or metastatic solid tumors with positive ALPP'], 'conditions': ['Recurrent or Metastatic Solid Tumors With Positive ALPP']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.', 'detailedDescription': 'This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of ALPP CAR-T cell therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-70 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. ALPP-positive tumor confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nKey Exclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B/C, syphilis).\n8. Pregnant or breastfeeding women.\n9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding.\n10. Severe systemic or psychiatric illness.\n11. Prior cell or gene therapy.\n12. Severe drug hypersensitivity history.\n13. Investigator-assessed unsuitability for trial participation.'}, 'identificationModule': {'nctId': 'NCT07123493', 'briefTitle': 'Engineered T-Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Beijing GoBroad Hospital'}, 'officialTitle': 'A Single-Arm, Single-Center, Open-Label Clinical Trial of Engineered T-Cell Therapy in Patients With ALPP-Positive Recurrent or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'A306-IIT-BJGB01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-ALPP CAR-T Cell Therapy', 'description': 'Biological: Anti-ALPP CAR-T Cells Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion.\n\nDrug: Fludarabine Drug: Cyclophosphamide', 'interventionNames': ['Biological: Anti ALPP CAR-T cells treatment']}], 'interventions': [{'name': 'Anti ALPP CAR-T cells treatment', 'type': 'BIOLOGICAL', 'description': 'Biological: anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide', 'armGroupLabels': ['Anti-ALPP CAR-T Cell Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haifeng Qin', 'role': 'CONTACT', 'email': 'hifo@263.net', 'phone': '+86 400-696-2000'}, {'name': 'Haifeng Qin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing GoBroad Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Haifeng Qin', 'role': 'CONTACT', 'email': 'hifo@263.net', 'phone': '+86 400-696-2000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haifeng Qin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haifeng Qin', 'investigatorAffiliation': 'Beijing GoBroad Hospital'}}}}