Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Patients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD08 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD08 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

NWRD08 administered by electroporation

Fang Jiang, M.D.

Yang Xiang, M.D.

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD08 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD08 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. Colposcopy and biopsy were performed at week 12, if HSIL was identified, loop electro-surgical excisional procedure (LEEP) or cold Knife conization (CKC) will be performed when necessary. The subjects were then followed up at week 36 and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved).

NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL

Phase I Safety and Tolerability Study of NWRD08 in HPV-16 and/or HPV-18 Related Cervical High-grade Squamous Intraepithelial Lesion (HSIL) Patients

all IPD that underlie results in a publication

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). The grade of injection-site AEs will be determined on the basis of the Guidelines for Adverse Event Classification Standards for Clinical Trials of Preventive Vaccines (2019) issued by the National Medical Products Administration.

t 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.

Immunologic reactogenicity by measuring HPV16/18 E6/E7 specific T cell response (IFN-γ ELISPOT) and anti-HPV16/18 E6/E7antibodies (ELISA) in blood samples.

Number of subjects with virologically-proven clearance of HPV 16 or 18 and number of subjects with histopathological regression of cervical lesions to CIN 1 or normal.

The recommended phase II dose (RP2D) was selected on the basis of tolerability during the safety expansion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.

Spots Global Cancer Trial Database for nwrd08 administered by electroporation