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

Korábbi kezelés

• 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.
• Infection requiring systemic treatment within 30 days prior to study Day 1.
• 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.
• Live vaccines administered within 30 days prior to study Day 1.
• Prior radiation therapy to a selected LDRT treatment site </= 30 days prior to Day 1.

Más betegség

• Active autoimmune disease requiring immunosuppressive therapy.
• History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
• Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
• Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.
• Allergy or intolerance to any of the study product ingredients or excipients.

Laborértékek

• 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.

Egyéb

• Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.
• Individuals lacking capacity to consent for themselves.
• Superior vena cava obstruction

• 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