NCT04990063

Adoptive TKC Transfer Combined With Chemotherapy for Advanced Non-small Cell Lung Cancer (NSCLC)

A Clinical Study on the Safety and Efficacy of Adoptive TKC Transfer Combined With Chemotherapy for Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: suhaichuan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Innate immune cells are an important part of the body's innate immune system, the first line of defense against infection and cancer. Tumor killer cells (TKC) are mixed cultures of two kinds of innate immune cells, namely natural killer cells (NK cells) and gamma delta T cells (γδT cells), which are co-activated and co-cultured ex-vivo in a certain proportion by the unique TKC technology. Adoptive TKC transfer is expected to exert a strong anti-tumor effect through synergistic action between NK cells and γδT cells. In this study, the safety, tolerance, and preliminary efficacy of adoptive TKC transfer combined with chemotherapy will be examined in patients with advanced NSCLC.

Detailed description

Primary Objective: ● To describe the safety profile and toxicity tolerance of combining adoptive TKC transfer with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Secondary Objectives: ● To evaluate the preliminary efficacy of combining adoptive TKC transfer with chemotherapy in the treatment of advanced NSCLC. Design: * This is a single-centre, open label, non-randomised, no control clinical trial. * NK cells and γδT cells are isolated from the patients' peripheral blood mononuclear cells (PBMCs) obtained before chemotherapy and then co-cultured with TKC technology ex-vivo. The mixed cultures will be used in multiple infusions under administration. The first infusion will be conducted in 7-10 days after chemotherapy and is assessed by the investigators. * Clinical responses will be evaluated closely in about 30 days and last up to 2 years after treatment.

Conditions

• Advanced Non-small Cell Lung Cancer
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Chemotherapy	Standard chemotherapy drug
BIOLOGICAL	Adoptive TKC transfer therapy	TKC: co-cultured autologous NK cells and γδT cells

Timeline

• Start date: 2021-08-08
• Primary completion: 2022-08-08
• Completion: 2023-11-30
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: China