NCT05020119

Neoantigen-expanded Autologous Immune Cell Therapy

A Phase I Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Neoantigen-expanded Autologous Immune Cell Therapy for Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients.

Detailed description

Cancer is the leading cause of death in the world. However, the response of traditional treatments(such as chemotherapy, radiotherapy, or target therapy) is yet limited. In this clinical trial study, the investigators will investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients. The similar clinical trial design and immune cell preparation have been recently published in international journals. Though adverse reactions (AE) have been reported, and there was no cases with severe adverse events (SAE), suggesting the safety of autologous immune cell therapy against cancers. The main propose of this clinical trial is to improve the treatment for solid tumors. By conducting this clinical trial, the investigators aim to enroll patients with refractory advanced solid tumors, and develop "neoantigen-expanded autologous immune cell therapy". The investigators will utilize "neoantigens" to expand the patients' autologous peripheral blood mononuclear cells into DC-CIK. The enrolled patients will receive autologous DC-CIK of 10 doses within 4\~5 months of treatment, and the safety, tolerability, and efficacy of this immune cell therapy will be evaluated.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Neoantigen-expanded cell therapy.	Infusion of personalized neoantigen-expanded T (CIK) cells

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-06-30
• Completion: 2023-06-30
• First posted: 2021-08-25
• Last updated: 2021-08-25

Locations

1 site across 1 country: Taiwan