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OncoMatch/Clinical Trials/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

Is NCT06069570 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies KB-GDT-01 for carcinoma, non-small-cell lung cancer.

Phase 1RecruitingKiromic BioPharma Inc.NCT06069570Data as of May 2026

Treatment: KB-GDT-01This 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Tumor Agnostic

Biomarker criteria

Allowed: ALK actionable molecular alteration

Allowed: BRAF actionable molecular alteration

Allowed: EGFR actionable molecular alteration

Allowed: KRAS actionable molecular alteration

Allowed: MET actionable molecular alteration

Allowed: RET actionable molecular alteration

Allowed: ROS1 actionable molecular alteration

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: platinum-based chemotherapy — NSCLC

Progressed on SOC therapy including platinum-based chemotherapy

Must have received: checkpoint inhibitor — NSCLC

Progressed on SOC therapy including...immune checkpoint inhibitors (NSCLC)

Must have received: targeted therapy — tumors with actionable molecular alterations

tumors with known actionable molecular alterations...must have progressed on appropriate target-directed molecular therapy

Must have received: zoledronic acid (zoledronic acid) — solid tumors with bone metastases (Part 2 Cohort B)

receiving zoledronic acid for solid tumors with bone metastases

Cannot have received: chemotherapy

Chemotherapy...within the 30 days prior to study Day 1

Cannot have received: checkpoint inhibitor

check-point inhibitor therapy within the 30 days prior to study Day 1

Cannot have received: investigational therapy

investigational...therapy within the 30 days prior to study Day 1

Cannot have received: radiation therapy

Prior radiation therapy to a selected LDRT treatment site </= 30 days prior to Day 1

Lab requirements

Blood counts

adequate hematopoietic function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

cardiac ejection fraction ≤ 50%, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, myocardial infarction, or marked baseline prolonged QT/QTc intervals [excluded]

Adequate hematopoietic, hepatic and renal function. 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 [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Arizona Cancer Center · Tucson, Arizona
  • Beverly Hills Cancer Center · Beverly Hills, California
  • UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
  • Texas Oncology - Tyler · Tyler, Texas
  • Virginia Oncology Associates · Norfolk, Virginia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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