Nctid:
NCT06617572
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008080", "term"=>"Liposarcoma"}, {"id"=>"D000013584", "term"=>"Sarcoma, Synovial"}, {"id"=>"D000018208", "term"=>"Liposarcoma, Myxoid"}], "ancestors"=>[{"id"=>"D000012509", "term"=>"Sarcoma"}, {"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000018205", "term"=>"Neoplasms, Adipose Tissue"}, {"id"=>"D000009372", "term"=>"Neoplasms, Connective Tissue"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "relevance"=>"LOW"}, {"id"=>"M16361", "name"=>"Sarcoma, Synovial", "asFound"=>"Synovial Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M11080", "name"=>"Liposarcoma", "asFound"=>"Liposarcoma", "relevance"=>"HIGH"}, {"id"=>"M20354", "name"=>"Liposarcoma, Myxoid", "asFound"=>"Myxoid Liposarcoma", "relevance"=>"HIGH"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M20351", "name"=>"Neoplasms, Adipose Tissue", "relevance"=>"LOW"}, {"id"=>"M12317", "name"=>"Neoplasms, Connective Tissue", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T5553", "name"=>"Synovial Sarcoma", "asFound"=>"Synovial Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T3479", "name"=>"Liposarcoma", "asFound"=>"Liposarcoma", "relevance"=>"HIGH"}, {"id"=>"T4027", "name"=>"Myxoid Liposarcoma", "asFound"=>"Myxoid Liposarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"EXPANDED_ACCESS", "expandedAccessTypes"=>{"intermediate"=>true}}, "statusModule"=>{"overallStatus"=>"AVAILABLE", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-17", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}}, "conditionsModule"=>{"conditions"=>["Synovial Sarcoma", "Myxoid Liposarcoma"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient must provide written informed consent prior to participating in this protocol\n* Patient must have been prescribed TECELRA®\n* Patient's commercially manufactured product does not meet the commercial release specification\n* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with Adaptimmune\n* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment\n* The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient\n* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment\n* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy\n\nExclusion Criteria:\n\n* Patient has contraindication(s) as per the TECELRA® USPI\n* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\\*02:05P"}, "identificationModule"=>{"nctId"=>"NCT06617572", "briefTitle"=>"Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Adaptimmune"}, "officialTitle"=>"Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification", "orgStudyIdInfo"=>{"id"=>"ADP-0044-999"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Non-conforming afamitresgene autoleucel", "type"=>"GENETIC", "description"=>"Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85259", "city"=>"Phoenix", "state"=>"Arizona", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Mahesh Seetharam, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Mayo Arizona", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"94305", "city"=>"Stanford", "state"=>"California", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Kristen Ganjoo, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Stanford Hospital and Clinics", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"32224", "city"=>"Jacksonville", "state"=>"Florida", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Steven Attia, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Mayo Florida", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33612", "city"=>"Tampa", "state"=>"Florida", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Mihaela Druta, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Moffit Cancer Center", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"60601", "city"=>"Chicago", "state"=>"Illinois", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Seth Pollack, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Northwestern University Feinberg School of Medicine", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"02144", "city"=>"Boston", "state"=>"Massachusetts", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Edwin Choy, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Massachusetts General Hospital", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Michael Wagner, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Dana-Farber Cancer Institute", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"55905", "city"=>"Rochester", "state"=>"Minnesota", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Steven Robinson, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Mayo Rochester", "geoPoint"=>{"lat"=>44.02163, "lon"=>-92.4699}}, {"zip"=>"10065", "city"=>"New York", "state"=>"New York", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Sandra D Angelo, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Memorial Sloan Kettering Cancer Centre", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"19111", "city"=>"Philadelphia", "state"=>"Pennsylvania", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Henry Fung, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Fox Chase Cancer Center", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "status"=>"AVAILABLE", "country"=>"United States", "contacts"=>[{"name"=>"Dejka Araujo, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"MD Anderson Cancer Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "centralContacts"=>[{"name"=>"Adaptimmune Patient Enquiries", "role"=>"CONTACT", "email"=>"patients@adaptimmune.com", "phone"=>"215-825-9260"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Adaptimmune", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
