NCT04518774

Allogeneic "Gammadelta T Cells (γδ T Cells)" Cell Immunotherapy in Phase 1 Hepatocellular Carcinoma Clinical Trial

The Safety Assessment of Ex-Vivo Expanded Allogeneic γδT Cells in Hepatocellular Carcinoma Patients in Phase 1 Clinical Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of hepatocellular carcinoma patients.

Detailed description

This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from of a blood-related donor of Hepatocellular Carcinoma (HCC) Patients. This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, treatments and follow-ups.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ex-vivo expanded allogeneic γδT cells	Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

Timeline

• Start date: 2020-08-15
• Primary completion: 2021-06-15
• Completion: 2021-08-15
• First posted: 2020-08-19
• Last updated: 2020-08-19

Locations

2 sites across 1 country: China