[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521436":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":32,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":32,"enrollmentInfo":147,"targetDuration":32,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":32,"overallStatus":65,"whyStopped":32,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Kiromic BioPharma Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KB-GDT-01 cells","EXPERIMENTAL","Dose Level 1: 400 x10\\^6, 800 x10\\^6 or 1600 x10\\^6 KB-GDT-01 cells + radiation (1.0 Gy\u002Ffraction)",[13],"Biological: KB-GDT-01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","KB-GDT-01","KB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells\u002Fbag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy\u002Ffraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10.",[9],[21],"Low dose radiotherapy",[23],{"name":24,"affiliation":25,"role":26},"Jason J Luke, MD, FACP","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Matthew Wagener, BS","CONTACT","1-844-539-2873",null,"mwagener@kiromic.com",{"name":35,"role":30,"phone":31,"phoneExt":32,"email":36},"Leonardo Mirandola, PhD","lmirandola@kiromic.com",[38,63,81,98,115],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The University of Arizona Cancer Center","NOT_YET_RECRUITING","Tucson","Arizona","85719","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-110.92648,32.22174,{"lat":50,"lon":49},[53,57,61],{"name":54,"role":30,"phone":55,"phoneExt":32,"email":56},"Mikayla Kirby","(520) 621-9656","mikaylakirby@arizona.edu",{"name":58,"role":30,"phone":59,"phoneExt":32,"email":60},"Margaret Ramirez","(520) 626-3677","ramirezm1@arizona.edu",{"name":62,"role":26,"phone":32,"phoneExt":32,"email":32},"Ricklie Julian, MD",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Beverly Hills Cancer Center","RECRUITING","Beverly Hills","California","90211",{"type":47,"coordinates":70},[71,72],-118.40036,34.07362,{"lat":72,"lon":71},[75,79],{"name":76,"role":30,"phone":77,"phoneExt":32,"email":78},"Ali Muhammad","(310) 432-8934","amuhammad@bhcancercenter.com",{"name":80,"role":26,"phone":32,"phoneExt":32,"email":32},"Afshin Gabayan, MD",{"facility":82,"status":65,"city":83,"state":84,"zip":85,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",{"type":47,"coordinates":87},[88,89],-79.99589,40.44062,{"lat":89,"lon":88},[92,96],{"name":93,"role":30,"phone":94,"phoneExt":32,"email":95},"IDDC Referrals","(878) 261 6063","IDDCReferrals@upmc.edu",{"name":97,"role":26,"phone":32,"phoneExt":32,"email":32},"Jason Luke, MD",{"facility":99,"status":65,"city":100,"state":101,"zip":102,"country":44,"countryCode":45,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Texas Oncology - Tyler","Tyler","Texas","75702",{"type":47,"coordinates":104},[105,106],-95.30106,32.35126,{"lat":106,"lon":105},[109,113],{"name":110,"role":30,"phone":111,"phoneExt":32,"email":112},"Jennifer Castner","(903) 579-9800","Jennifer.castner@usoncology.com",{"name":114,"role":26,"phone":32,"phoneExt":32,"email":32},"Donald Richards, MD, PhD",{"facility":116,"status":65,"city":117,"state":118,"zip":119,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"type":47,"coordinates":121},[122,123],-76.28522,36.84681,{"lat":123,"lon":122},[126,130],{"name":127,"role":30,"phone":128,"phoneExt":32,"email":129},"Karen McClain","(757) 213-5658","Karen.mcclain@usoncology.com",{"name":131,"role":26,"phone":32,"phoneExt":32,"email":32},"Gary Simmons, DO, MSHA",{"type":133,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[135],{"name":136,"class":137},"Stiris Research Inc","UNKNOWN","100521436","phase-1-safety-study-for-a-gamma-delta-t-cell-product-used-with-low-dose-radiotherapy-in-patients-with-locally-advanced-or-metastatic-nsclc-or-solid-tumors-with-bone-metastases-100521436",false,"NCT06069570","Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Locally Advanced or Metastatic NSCLC or Solid Tumors With Bone Metastases","Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors With Bone Metastases","Inclusion Criteria:\n\n* Signed and dated informed consent form.\n* Male or female, \\> 18 years old.\n* Minimum body weight of 50 kilograms (kg).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis\n* Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and\u002For have exhibited intolerance to and\u002For declined clinically applicable salvage therapies, and\u002For have declined therapy.\n* Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.\n* At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease\n* All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.\n* Adequate hematopoietic, hepatic and renal function\n* Agree to adequate contraception for up to 120 days after the last dose of study drug.\n* Negative serum pregnancy test for women of childbearing potential\n* All primary and metastatic disease sites are amenable to LDRT\n* For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases\n\nExclusion Criteria:\n\n* Chemotherapy, investigational, and\u002For check-point inhibitor therapy within the 30 days prior to study Day 1.\n* Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* Infection requiring systemic treatment within 30 days prior to study Day 1.\n* History of peritoneal effusion (ascites), pericardial, or pleural effusions\u002Fnodules.\n* Uncontrolled hypertension, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT\u002FQTc intervals.\n* Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.\n* Participation in the treatment portion of a clinical trial or completed a clinical trial within the 30 days prior to the first dose of KB-GDT-01.\n* Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.\n* Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.\n* Allergy or intolerance to any of the study product ingredients or excipients.\n* Live vaccines administered within 30 days prior to study Day 1.\n* Individuals lacking capacity to consent for themselves.\n* Superior vena cava obstruction\n* Prior radiation therapy to a selected LDRT treatment site \\\u003C\u002F= 30 days prior to Day 1.","ALL","18 Years",{"count":148,"type":149},48,"ESTIMATED","INTERVENTIONAL",[152],"PHASE1","This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.",[155,156],"Carcinoma, Non-Small-Cell Lung Cancer","Bone Metastases From Solid Tumors","2025-03-03",{"date":159,"type":160},"2025-03-05","ACTUAL",{"date":162,"type":160},"2023-11-07",{"date":164,"type":149},"2026-10",{"name":5,"class":6},5]