Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-29 @ 10:33 AM
Study NCT ID:
NCT06228404
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'SEQUENTIAL', 'interventionModelDescription': 'A：0.25×106/kgBW B: 0.75×106/kgBW C: 2×106/kgBW'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'Within 28 Days After Enhanced autologous PSMA-CAR T Infusion', 'description': 'The number and severity of dose-limiting toxicity (DLT) events'}], 'secondaryOutcomes': [{'measure': 'PSA response rate', 'timeFrame': 'From 3 weeks to 6 months after Enhanced autologous PSMA-CAR T infusion', 'description': 'PSA50 response, PSA90 response: PSA response determined as ≥ 50% or ≥ 90% reduction in PSA level from baseline to post-baseline and reassessed at least 3 weeks later'}, {'measure': 'ORR', 'timeFrame': '6 months after Enhanced autologous PSMA-CAR T infusion', 'description': 'Objective response rate ORR = CR + PR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Castration-resistant Prostate Cancer', 'Metastasis', 'Prostate-Specific Membrane Antigen', 'Chimeric Antigen Receptor T cell', 'Refractory Castration-resistant Prostate Cancer'], 'conditions': ['Metastatic Castration-resistant Prostate Cancer', 'Castration-resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.', 'detailedDescription': 'This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C). Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fully understood and voluntarily signed informed consent for this study;\n2. male, aged 18-75 years;\n3. expected survival of more than 6 months;\n4. metastatic castration-resistant prostate adenocarcinoma (CRPC) patients.\n5. Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression);\n6. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment;\n7. ECOG score \\< 2 ;\n8. virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening method unknown, confirmed by nucleic acid method); hematological parameters met the following criteria: a. hemoglobin \\> 100 g/L; b. platelet count \\> 100 × 109/L; c. neutrophils \\> 1.5 × 109/L.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be excluded:\n\n1. have received any previous treatment with CAR-T therapy ;\n2. have received any previous treatment that targets PSMA;\n3. tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)\n4. severe mental disorders;\n5. suffered from previous malignancies, except for the following: a. basal cell carcinoma or squamous cell carcinoma after standardized treatment; b. having a primary malignancy, but completely resected, with a complete remission time of ≥ 5 years.\n6. Subjects with severe cardiovascular disease; a.New York Heart Association (NYHA) stage III or IV congestive heart failure; b.Myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); c.Clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; d.History of severe non-ischemic cardiomyopathy; e.Decreased left ventricular ejection fraction (LVEF \\< 55%) as assessed by echocardiogram or multigated acquisition (MUGA) scan, abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis;\n7. active infectious disease or any major infectious event requiring high grade antibiotics;\n8. organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase \\> 2.5ULN; CK \\> ULN; CK-MB \\> ULN; TnT \\> 1.5ULN; b. total bilirubin \\> 1.5ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio \\> 1.5ULN in the absence of anticoagulant therapy;\n9. participation in other clinical studies in the past three months or previous treatment with any gene therapy product;\n10. intolerance or hypersensitivity to cyclophosphamide and fludarabine chemotherapy;\n11. unsuitability to participate in this clinical study in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06228404', 'briefTitle': 'Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'The Safety and Efficacy Evaluation of Enhanced Autologous PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': '2022-BRL-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced autologous PSMA-CAR T:', 'description': 'Enhanced autologous PSMA-CAR T is an electrotransfer system based on non-viral transposons that integrates the CAR gene into the genome of host cells by electrotransfer using PMSA as a target, while this CAR vector co-expresses enhanced factors and plays a strong regulatory role in innate and adaptive immunity.', 'interventionNames': ['Drug: Enhanced autologous PSMA-CAR T']}], 'interventions': [{'name': 'Enhanced autologous PSMA-CAR T', 'type': 'DRUG', 'description': '3 escalated dosing cohorts are designed to explore safety and efficacy of enhanced autologous PSMA-CAR T:\n\ncohort A： CART-PSMA cells 0.25×106/kgBW, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;\n\ncohort B： CART-PSMA cells 0.75×106/kgBW，following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;\n\ncohort C： CART-PSMA cells 2×106/kgBW，following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;', 'armGroupLabels': ['Enhanced autologous PSMA-CAR T:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201109', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shancheng Ren, PhD', 'role': 'CONTACT', 'email': 'renshancheng@gmail.com', 'phone': '13917793885'}], 'facility': 'Changzheng hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shancheng Ren, MD/PhD', 'role': 'CONTACT', 'email': 'renshancheng@gmail.com', 'phone': '139 1779 3885'}, {'name': 'Weidong Xu', 'role': 'CONTACT', 'email': 'ayxwd@qq.com', 'phone': '139 1687 9385'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bioray Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Urology', 'investigatorFullName': 'Ren Shancheng', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}