Nctid:
NCT06228404
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M6727", "name"=>"Cyclophosphamide", "relevance"=>"LOW"}, {"id"=>"M283230", "name"=>"Fludarabine", "relevance"=>"LOW"}, {"id"=>"M225513", "name"=>"Fludarabine phosphate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "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", "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"}}}}