Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung Cancer
- Registration Number
- NCT06069570
- Lead Sponsor
- Kiromic BioPharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria:<br><br> - Signed and dated informed consent form.<br><br> - Male or female, > 18 years old.<br><br> - Minimum body weight of 50 kilograms (kg).<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.<br><br> - Histologically or cytologically confirmed stage 4 metastatic NSCLC<br><br> - Progressed on at least 2 lines of SOC therapy including platinum-based chemotherapy<br> and immune checkpoint inhibitors.<br><br> - Genomic screening, with tumors with known actionable molecular alterations, such as<br> EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate<br> target-directed molecular therapy.<br><br> - At least one measurable target lesion based on RECIST v1.1<br><br> - All toxicity associated with previous treatments are recovered to CTCAE grade of =1,<br> except for continuing alopecia.<br><br> - Life expectancy of at least 6 months.<br><br> - Adequate hematopoietic, hepatic and renal function<br><br> - Agree to adequate contraception for up to 120 days after the last dose of study<br> drug.<br><br> - Negative serum pregnancy test for women of childbearing potential<br><br>Exclusion Criteria:<br><br> - Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30<br> days prior to study Day 1.<br><br> - Major surgery, except for vascular access placement, within the 30 days prior to<br> study Day 1.<br><br> - Active autoimmune disease requiring immunosuppressive therapy.<br><br> - Infection requiring systemic treatment within 30 days prior to study Day 1.<br><br> - History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.<br><br> - Uncontrolled hypertension, history of arrhythmia including atrial fibrillation,<br> unstable angina, decompensated congestive heart failure, cardiac ejection fraction =<br> 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals.<br><br> - Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.<br><br> - Participation in the treatment portion of a clinical trial or completed a clinical<br> trial within the 30 days prior to the first dose of KB-GDT-01.<br><br> - Presence of any condition that may, in the opinion of the Investigator, render the<br> patient inappropriate from participating in the study.<br><br> - Breastfeeding or pregnant female, or patient is expecting to conceive or father<br> children during the study.<br><br> - Allergy or intolerance to any of the study product ingredients or excipients.<br><br> - Live vaccines administered within 30 days prior to study Day 1.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR);Progression Free Survival (PFS);Overall Survival (OS);Time to Progression (TTP);Time to Treatment Response (TTR);Disease Control Rate (DCR)