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Vaccines

Patients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

DNA plasmid delivered via IM injection + electroporation using TERESA device

1mg NWRD06 administered by electroporation

4mg NWRD06 administered by electroporation

8mg NWRD06 administered by electroporation

Defang Liu, Ph.D.

Zhen Huang, M.D.

Hong Zhao, M.D.

Zhao Hong, Ph.D.

This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum tolerated dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.

Immunologic reactogenicity in blood samples was assessed at week 0, week 2, week 4, week 6, week 8, week 10, week 12.

Peripheral blood samples were then collected every 3 months for immunogenicity assessment until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).

This study is divided into three dose groups climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle.

Three dose groups were preset in this study: dose group 1 and low-dose group \[a single dose of 1mg was administered three times at week 0, 4 and 8, respectively, with cumulative administration of 3mg\]; Dose group 2, middle-dose group \[single dose of 4mg, administered 3 times at week 0, 4, 8, respectively, cumulative administration of 12mg\]; Dose group 3, high-dose group \[a single dose of 8mg, administered at week 0, 4 and 8, a total of 3 times, cumulative administration of 24mg\].

After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.

NWRD06 DNA Plasmid for HCC After Radical Resection

Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection

all IPD that underlie results in a publication

It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the last dosing will be classified as DLT during dosing climb.

All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)

GPC3 specific immune response in peripheral blood

Spots Global Cancer Trial Database for 8mg nwrd06 administered by electroporation