Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Phase 1

Completed

• Conditions: Brain Cancer; Neoplasm Metastases
• Interventions: Biological: Personalized cellular vaccine

• Registration Number: NCT02808416
• Lead Sponsor: Guangdong 999 Brain Hospital

Brief Summary

Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy will be observed in this study.

Detailed Description

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM criteria, progression-free survival and overall survival.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Primary Completion: 2017-10-31
• Study Completion: 2019-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Solid tumor with brain metastases.
• Patients at the age of 18-65.
• Patients undergo tumor resection or biopsy.
• Patients with Karnofsky scores > or =70
• Patients with normal range of hematologic and metabolic test results.
• Patients must have no corticosteroids treatment at least one week before vaccination.
• Patients capable of understanding the study and signed informed consent.

Exclusion Criteria

• Infectious diseases HIV, HBV, HCV.
• Documented immunodeficiency.
• Documented autoimmune disease.
• Breast feeding females.
• Pregnant women.
• Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
• Patient inability to participate as determined by PI discretion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized cellular vaccine	Personalized cellular vaccine	Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)	3 years since the beginning of the first vaccine	Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC vaccines.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	24 months since the beginning of the first vaccine	Progression-free survival will be monitored for 2 year
Antitumor specific T cell response	4 weeks after the last vaccine	The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Overall survival	3 years since the beginning of the first vaccine	Overall survival will be monitored for 3 years

Trial Locations

Locations (1)

Guangdong 999 Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China