RecruitingPhase 1NCT06069570

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


Sponsor

Kiromic BioPharma Inc.

Enrollment

48 participants

Start Date

Nov 7, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy — called gamma delta T cells — combined with low-dose radiation, for people with advanced lung cancer or solid tumors that have spread to the bones. Researchers are checking whether this treatment is safe. **You may be eligible if...** - You are 18 or older and weigh at least 50 kg - You have advanced non-small cell lung cancer (NSCLC) or a solid tumor with bone metastases - Your cancer has progressed after standard treatments including platinum-based chemotherapy and immunotherapy - You are in fairly good physical condition (ECOG score 0–1) **You may NOT be eligible if...** - You have active autoimmune disease or are on immune-suppressing drugs - You have uncontrolled brain metastases - You have had prior treatment with gamma delta T cell therapy - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALKB-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.


Locations(5)

The University of Arizona Cancer Center

Tucson, Arizona, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06069570


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