Nctid:
NCT06614686
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D009303", "term"=>"Nasopharyngeal Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D010610", "term"=>"Pharyngeal Neoplasms"}, {"id"=>"D010039", "term"=>"Otorhinolaryngologic Neoplasms"}, {"id"=>"D009302", "term"=>"Nasopharyngeal Diseases"}, {"id"=>"D010608", "term"=>"Pharyngeal Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}, {"id"=>"D010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "asFound"=>"Head and Neck Tumors", "relevance"=>"HIGH"}, {"id"=>"M12254", "name"=>"Nasopharyngeal Neoplasms", "asFound"=>"Nasopharynx Cancer", "relevance"=>"HIGH"}, {"id"=>"M13517", "name"=>"Pharyngeal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12962", "name"=>"Otorhinolaryngologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12253", "name"=>"Nasopharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M13515", "name"=>"Pharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]", "timeFrame"=>"28 days post administration of CAR-T-cells", "description"=>"An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)"}], "secondaryOutcomes"=>[{"measure"=>"Pharmacokinetics of U87 CAR-T cells", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Time at the maximal concentration(Tmax)"}, {"measure"=>"Pharmacokinetics of U87 CAR-T cells", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Area under the concentration-time curve(AUC)"}, {"measure"=>"Pharmacokinetics of U87 CAR-T cells", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"The maximal concentration of eripheral blood (Cmax)"}, {"measure"=>"Pharmacodynamics of U87 CAR-T cells", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point"}, {"measure"=>"Objective Response Rate (ORR), as assessed by Investigators", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1."}, {"measure"=>"Duration of response (DOR), as assessed by Investigators", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death."}, {"measure"=>"Overall survival (OS)", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Overall Survival (OS) was defined as the time from the date of first infusion of U87 to the date of death due to any cause."}, {"measure"=>"Progression-free survival (PFS), as assessed by Investigators", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause."}, {"measure"=>"Disease control rate (DCR), as assessed by Investigators", "timeFrame"=>"2 years post CAR T cell infusion", "description"=>"Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Chimeric Antigen Receptor T Cell", "U87"], "conditions"=>["Nasopharynx Cancer", "Head and Neck Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.", "detailedDescription"=>"Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Subjects have provided informed consent, understanding the study\\'s risks and benefits, and are willing to complete the study procedures.\n2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.\n3. ECOG performance status of 0-1.\n4. Anticipated survival of at least 12 weeks.\n5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available\n6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.\n7. At least one measurable tumor lesion according to RECIST 1.1.\n8. Suitable venous access for mononuclear cell collection.\n9. Adequate major organ function.\n10. Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.\n2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.\n3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.\n4. Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.\n5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.\n6. Active infection requiring intravenous anti-infective therapy.\n7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.\n8. Primary immunodeficiency or active autoimmune disease.\n9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.\n10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.\n11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.\n12. Allergy to protein drugs or multiple medications.\n13. Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.\n14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.\n\n Pregnant or breastfeeding women.\n15. Uncontrollable psychiatric history.\n16. Other conditions deemed unsuitable for study participation by the investigator."}, "identificationModule"=>{"nctId"=>"NCT06614686", "briefTitle"=>"U87 CAR-T in Patients With Advanced Head and Neck Tumors", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd"}, "officialTitle"=>"A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors", "orgStudyIdInfo"=>{"id"=>"U87-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"U87 autologous CAR T-cell injection", "description"=>"Two stages: dose escalation and dose expansion", "interventionNames"=>["Drug: U87 autologous CAR T-cell"]}], "interventions"=>[{"name"=>"U87 autologous CAR T-cell", "type"=>"DRUG", "description"=>"Treatment with U87 chimeric antigen receptor T-cell infusion.", "armGroupLabels"=>["U87 autologous CAR T-cell injection"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200000", "city"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Jian Chen, Ph.D", "role"=>"CONTACT", "email"=>"chenjent@qq.com", "phone"=>"18917785406"}, {"name"=>"Hongmeng Yu, Ph.D", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Eye ENT Hospital of Fudan University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"Haitao Wu, Ph.D", "role"=>"CONTACT", "email"=>"eentwuhaitao@163.com", "phone"=>"13585504678"}, {"name"=>"Jian Chen, Ph.D", "role"=>"CONTACT", "email"=>"wzcj21@163.com", "phone"=>"18917785406"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
