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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed and dated willing to sign a consent form form. - Male or female, \> 18 years old. - Minimum body weight of 50 kilograms (kg). - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis - 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/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy. - 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. - 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 - All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia. - Adequate hematopoietic, hepatic and renal function - Agree to adequate contraception for up to 120 days after the last dose of study drug. - Negative serum pregnancy test for women of childbearing potential - All primary and metastatic disease sites are amenable to LDRT - For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases Who Should NOT Join This Trial: - Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1. - Major surgery, except for vascular access placement, within the 30 days prior to study Day 1. - Active autoimmune conditions (where your immune system attacks your own body) requiring immunosuppressive therapy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Signed and dated informed consent form. * Male or female, \> 18 years old. * Minimum body weight of 50 kilograms (kg). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis * 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/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy. * 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. * 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 * All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia. * Adequate hematopoietic, hepatic and renal function * Agree to adequate contraception for up to 120 days after the last dose of study drug. * Negative serum pregnancy test for women of childbearing potential * All primary and metastatic disease sites are amenable to LDRT * For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases Exclusion Criteria: * Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1. * Major surgery, except for vascular access placement, within the 30 days prior to study Day 1. * Active autoimmune disease requiring immunosuppressive therapy. * Infection requiring systemic treatment within 30 days prior to study Day 1. * History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules. * 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/QTc intervals. * Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection. * 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. * Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study. * Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study. * Allergy or intolerance to any of the study product ingredients or excipients. * Live vaccines administered within 30 days prior to study Day 1. * Individuals lacking capacity to consent for themselves. * Superior vena cava obstruction * Prior radiation therapy to a selected LDRT treatment site \</= 30 days prior to Day 1.

Treatments Being Tested

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/bag. 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/fraction 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.

Locations (5)

The University of Arizona Cancer Center
Tucson, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States