Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

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 Stage 4 Metastatic Non-Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with metastatic non-small cell lung cancer to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.

Clinical Trial Description

In this clinical trial, or 'study', participants with stage 4, non-small cell cancer (NSCLC), will receive KB-GDT-01, an allogeneic (cells from healthy donors) gamma delta T-cell product. All participants will receive KB-GDT-01 as intravenous infusions in combination with radiotherapy. After being informed about the study and its potential risks, during the 28-day screening period, all consented participants will have laboratory tests, assessments, tumor scans, and a tumor biopsy. Cytokine release syndrome symptoms and other potential adverse effects, will be monitored during the dose limiting toxicity period. The study will be conducted in 2 parts, with the same number of visits in each part. In Part 1 Dose Escalation, the study will attempt to identify the best dose with the lowest incidence of adverse effects (AE) and try to identify if the KB-GDT-01 is working (effectiveness). In Part 2 Dose Expansion the best dose will be further investigated for AE and effectiveness. There will be up to 36 participants in Part 1 and up to 12 additional participants in Part 2 of the study. The total treatment cycle of the study drug protocol will be completed in 10 days. Participants will then attend clinic visits during a 30-day short-term follow-up period, with a subsequent long-term follow-up period up to Month 24 ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

• NCT number: NCT06069570
• Study type: Interventional
• Source: Kiromic BioPharma Inc.
• Contact: Rose Marie Cavanna-Mast, CCRA
• Phone: 1-844-539-2873
• Email: rcavannamast@kiromic.com
• Status: Recruiting
• Phase: Phase 1
• Start date: November 7, 2023
• Completion date: January 2027