Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with metastatic non-small cell lung cancer to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | January 2027 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 stage 4 metastatic NSCLC - Progressed on at least 2 lines of SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors. - 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 - All toxicity associated with previous treatments are recovered to CTCAE grade of =1, except for continuing alopecia. - Life expectancy of at least 6 months. - 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Beverly Hills Cancer Center & Optima Diagnostic Imaging | Beverly Hills | California |
United States | University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kiromic BioPharma Inc. | Statistics & Data Corporation, Stiris Research Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication. | From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later | |
Secondary | Objective Response Rate (ORR) | Investigator assessed ORR per RECIST v1.1. ORR is defined as the percentage of participants with a best overall response of complete or partial response. | From first study drug infusion through to Month 24 | |
Secondary | Progression Free Survival (PFS) | Investigator assessed PFS per RECIST v1.1. PFS is defined as the time from first study drug infusion until the first evidence of disease progression or death. | From first study drug infusion until the first evidence of disease progression, death or Month 24. | |
Secondary | Overall Survival (OS) | Investigator assessed OS per RECIST v1.1. OS is defined as the time from first study drug infusion to death. | From first study drug infusion until death or Month 24. | |
Secondary | Time to Progression (TTP) | Investigator assessed TTP per RECIST v1.1. TTP is defined as the time from first study drug infusion until first evidence of disease progression. | From first study drug infusion until first evidence of disease progression or Month 24. | |
Secondary | Time to Treatment Response (TTR) | Investigator assessed TTR per RECIST v1.1. TTR is defined as the time from first study drug infusion until first evidence of disease response. | From first study drug infusion until first evidence of disease response or Month 24. | |
Secondary | Disease Control Rate (DCR) | Investigator assessed DCR per RECIST v1.1 DCR is defined as the percentage of participants with complete response, partial response or stable disease. | From first study drug infusion until first evidence of disease response or stable disease or Month 24. |
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