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
Kiromic BioPharma Inc.
48 participants
Nov 7, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- 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 Criteria15
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06069570