Nctid:
NCT06235242
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000002289", "term"=>"Carcinoma, Non-Small-Cell Lung"}], "ancestors"=>[{"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "asFound"=>"Non-small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2027-01-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-18", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Safety Profile Measured by Grade ≥3 TRAEs", "timeFrame"=>"3 years", "description"=>"Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["GT201"], "conditions"=>["Adult", "Non-small Cell Lung Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;\n* 2. Age 18 to 70 years old;\n* 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 4. Expected survival time of ≥ 12 weeks;\n* 5. Good function of vital organs;\n* 6. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;\n* 7. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.\n\nExclusion Criteria:\n\n* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;\n* 2.Known mental illness, alcoholism, drug use or substance abuse;\n* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;\n* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;\n* 5.The investigators determine that other conditions that make the patient not suitable for enrollment."}, "identificationModule"=>{"nctId"=>"NCT06235242", "briefTitle"=>"GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Grit Biotechnology"}, "officialTitle"=>"A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer", "orgStudyIdInfo"=>{"id"=>"GRIT-CD-CHN-201-002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"GT201 treatment group", "interventionNames"=>["Biological: GT201 injection in combination with teraplizumab injection"]}], "interventions"=>[{"name"=>"GT201 injection in combination with teraplizumab injection", "type"=>"BIOLOGICAL", "description"=>"GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer", "armGroupLabels"=>["GT201 treatment group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200120", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Jin Li, PHD", "role"=>"CONTACT", "email"=>"lijin@csco.org.cn", "phone"=>"+86 13761222111"}], "facility"=>"Shanghai East Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}, {"zip"=>"200120", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Yayi He, PHD", "role"=>"CONTACT", "email"=>"doctorjael@qq.com", "phone"=>"+86 13818828623"}], "facility"=>"Shanghai GoBroad Cancer Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"Yayi He, PHD", "role"=>"CONTACT", "email"=>"doctorjael@qq.com", "phone"=>"+86 13818828623"}, {"name"=>"Jin Li, PHD", "role"=>"CONTACT", "email"=>"lijin@csco.org.cn", "phone"=>"+86 13761222111"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Grit Biotechnology", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
