Clinical trial Recruiting at 4 sites Phase 1 Interventional Ages 18 and up

Using gamma delta T cells with low dose radiotherapy for advanced lung cancer and bone metastases

Official title: 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

Run by Kiromic BioPharma Inc. · NCT06069570 · Data updated 2026-11-12

This study is testing whether using special immune cells along with low dose radiation can help people with advanced lung cancer and bone metastases feel better.

More Bone Metastases From Solid Tumors trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment48 (estimated)
SponsorKiromic BioPharma Inc.
Industry-sponsored
Drugs / interventionschemotherapy, radiation, immunotherapy
Locations5 sites (Tucson, Arizona and 4 other locations)
StatusRecruiting
StartedNovember 7, 2023
Main results expectedOctober 2025
Study endsOctober 2026
Registry record updatedMarch 5, 2025
Trial IDNCT06069570 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with advanced NSCLC or solid tumors with bone metastases who have progressed on standard therapies and are not candidates for further conventional treatments.

Probably not a fit

Patients with early-stage cancer or those who have not yet undergone standard treatment options may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of intravenous infusions of allogeneic gamma delta T cells combined with low dose radiotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or solid tumors with bone metastases. Participants will undergo a 28-day screening period involving laboratory tests, tumor scans, and biopsies. The trial consists of two parts: a dose escalation phase to determine the optimal dose with minimal adverse effects, followed by a dose expansion phase to further assess safety and effectiveness. The total treatment period lasts 31 days, followed by a short-term follow-up of 30 days and long-term follow-up up to 12 months.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of radiotherapy in patients with advanced cancer.

How similar studies have gone: Other studies have shown promise in combining immunotherapy with radiation therapy, suggesting potential for success in this novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Beverly Hills Cancer Center
    Beverly Hills, California, United States
    Recruiting
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Texas Oncology - Tyler
    Tyler, Texas, United States
    Recruiting
  • Virginia Oncology Associates
    Norfolk, Virginia, United States
    Recruiting
  • The University of Arizona Cancer Center
    Tucson, Arizona, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.