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

Launched by KIROMIC BIOPHARMA INC. · Sep 29, 2023

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ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with stage 4 metastatic non-small cell lung cancer (NSCLC). The study will combine two forms of therapy: a special type of immune cell called gamma delta T cells and low dose radiation therapy. The main goal is to see if this combination is safe and effective in helping patients who have already tried other treatments.

To participate, you need to be over 18 years old, weigh at least 50 kilograms, and have been diagnosed with stage 4 NSCLC that has progressed after receiving at least two previous treatments. Participants should also be in relatively good health, with manageable side effects from prior therapies. If you join the study, you will receive infusions of these immune cells after undergoing low dose radiation, and doctors will closely monitor your health throughout the trial to ensure your safety. It's important to know that there are some criteria that might prevent you from participating, such as recent treatments or certain health conditions, so discussing your eligibility with your healthcare provider would be a good first step.

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Eligibility criteria

• 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.