NCT06069570 · Kiromic BioPharma Inc.
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
What this study is about
This is a clinical trial studying given through a vein (IV) 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 effectiveness of combining immunotherapy with radiation therapy.
View original scientific description
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.
Interventions
BIOLOGICAL
KB-GDT-01
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.
Primary outcome measures
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
Time frame: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tucson, Arizona
- Beverly Hills, California
- Pittsburgh, Pennsylvania
- Tyler, Texas
- Norfolk, Virginia
Collaborators
Stiris Research Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2025 · Source of record for eligibility and locations