Safety Study of KB-GDT-01 with Radiotherapy for NSCLC or Solid Tumors with Bone Metastases
This study is testing a new treatment called KB-GDT-01, which uses special immune cells (gamma delta T-cells) from healthy donors, combined with low-dose radiation therapy. It's for people with advanced non-small cell lung cancer (NSCLC) or other solid tumors that have spread to the bones. The main goal is to see if this combination is safe and well-tolerated. You might be able to join if you are over 18, weigh at least 50 kg, and your cancer has progressed after standard treatments. The study will also look for signs that the treatment is working. This trial is currently recruiting up to 48 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll up to 48 participants. It will be conducted in two parts: a dose escalation phase followed by a dose expansion phase.
- What's involved
- You would receive KB-GDT-01 as intravenous infusions combined with radiotherapy over 31 days. This involves a 28-day screening period with tests and scans, and clinic visits during and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have a short-term follow-up for 30 days after treatment, and a long-term follow-up for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06069570
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentKiromic BioPharma Inc.
~48 participants
Updated 2025-03-05 on ClinicalTrials.gov
What's tested:KB-GDT-01
At a glance
Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later
Conditions
Where it's being run
5 sites across 5 statesArizona1
California1
Pennsylvania1
Texas1
Virginia1
Study leadership
- Jason J Luke, MD, FACP · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial 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 LDRTFrom 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.