Neoplasms

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Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All Drugs and Chemicals

Vaccines

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

Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen mRNA pulsed cellular vaccines.

Other Names:

• Tumor antigen pulsed DC and PBMC, autologous tumor vaccine

Personalized cellular vaccine

Jian Zhang, M.D.

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.

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.

Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors

Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC vaccines.

The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.

Progression-free survival will be monitored for 2 year

Overall survival will be monitored for 3 years

Beijing Tricision Biotherapeutics Inc

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Jinan University Guangzhou

Guangdong 999 Brain Hospital

Vice President of the hospital and Chief Physician

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Immunologic Factors

Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.

Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the study.

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.

Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)

Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC cellular vaccine

The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine.

Progression-free survival will be monitored for 1year.

Overall survival will be monitored for 3 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)	NCT02808416	Brain Cancer Neoplasm Metast...	Personalized ce...	18 Years - 65 Years	Guangdong 999 Brain Hospital
Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)	NCT02709616	Glioblastoma	Personalized ce...	18 Years - 65 Years	Guangdong 999 Brain Hospital
Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)	NCT02709616	Glioblastoma	Personalized ce...	18 Years - 65 Years	Guangdong 999 Brain Hospital
Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)	NCT02808416	Brain Cancer Neoplasm Metast...	Personalized ce...	18 Years - 65 Years	Guangdong 999 Brain Hospital

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