[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-non-small-cell-lung-cancer":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Carcinoma, Non-Small-Cell Lung Cancer","Bone Metastases From Solid Tumors","RECRUITING","2025-03-03",{"date":31,"type":32},"2025-03-05","ACTUAL",{"date":34,"type":32},"2023-11-07",{"date":36,"type":20},"2026-10",{"name":38,"class":39},"Kiromic BioPharma Inc.","INDUSTRY",5,"Carcinoma, Non-Small-Cell-Lung Cancer"]