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

Last updated: February 18, 2024
Sponsor: Newish Technology (Beijing) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Genitourinary Cancer

Precancerous Condition

Lung Cancer

Treatment

NWRD08 administered by electroporation

Clinical Study ID

NCT06276101
NEWISH-HPV-101
  • Ages 18-60
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female aged between 18 and 60 years;
  2. histopathological examination/biopsy confirmed HPV-16 and/or HPV-18-associatedcervical High-grade squamous intraepithelial lesion (HSIL);
  3. The electrocardiograms deemed normal or with abnormalities not considered clinicallysignificant by the site investigators.
  4. Major organ functions were normal within 1 week before the first NWRD08administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤1.5× upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Plasmaalbumin ≥30 g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min (serum creatinine > 1.5 x ULN);
  5. Within 1 week before the first NWRD08 administration, women of childbearing age musthave a negative serum pregnancy test and consent to use effective contraception formthe signing of the ICF to the end of the study.
  6. Have fully understood the study and voluntarily signed the ICF, have goodcommunication with the investigator, and are able to complete all treatments,examinations, and visits stipulated in the study protocol.

Exclusion

Exclusion Criteria:

  1. Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar,vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologicspecimen at screening;
  2. Pregnant, breastfeeding or considering becoming pregnant during the study;
  3. Administration of any non-live vaccines within 2 weeks prior to the first NWRD08administration;
  4. Administration of any live vaccines within 4 weeks prior to the first NWRD08administration;
  5. Treatment for cervical HSIL within 4 weeks prior to the first NWRD08 administration;
  6. Any metallic implants/implanted electric devices around the intended sites ofelectroporation (deltoid muscles);
  7. Participated in another clinical trial or was under observation in another clinicaltrial within 30 days prior to screening;
  8. Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone > 10 mg/ day) within 30 days prior to screening, except hormone replacementtherapy, intratracheal, ocular and topical administration;
  9. A history of immune deficiency or autoimmune diseases (e.g., rheumatoid joint disease,systemic lupus erythematosus, multiple sclerosis, etc.);
  10. Current or intended use of disease-modifying antirheumatic drugs (e.g., azathioprine,cyclophosphamide, cyclosporin and methotrexate) and biologic drugs (e.g., infliximab,adalimumab and etanercept);
  11. Continuous (more than 1 week) use of immunosuppressive agents. (e.g., cyclosporin,tacrolimus, azathioprine, 6-mercaptoputine and antilymphocyte globulin, etc.);
  12. Patients with a history of solid organ or bone marrow transplantation;
  13. With uncontrolled severe infection (> grade 2 NCI-CTCAE adverse events, version 5.0);
  14. Patients with a history of human immunodeficiency virus (HIV) infection or carriers ofsyphilis;
  15. Patients who are found to have active zoster virus infections;
  16. Patients with serious other organ dysfunction or cardiopulmonary diseases;
  17. Epilepsy that requires treatment with medication (e.g. steroids or antiepilepticdrugs);
  18. Had or currently has other malignancies (with the exception of adequately treated andcompletely cured ductal carcinoma in situ of the breast, carcinoma in situ of thecervix, basal cell carcinoma of the skin, superficial bladder tumor, or any malignancythat was cured more than 5 years before study entry);
  19. A known history of albumin allergy, or severe allergy, or allergic disease, orallergic constitution, or severe iodine contrast allergy, meeting any of thesecriteria;
  20. Patients with clinically significant heart disease or medical history;
  21. Severe mental illness;
  22. A history of drug or alcohol abuse;
  23. Pregnant or lactating women, or women of childbearing age with positive bloodpregnancy tests, or women of reproductive age and their spousal not willing to usecontraception during and up to 6 months following completion of the study;
  24. Patients deemed by the investigator to be ineligible for this clinical trial.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: NWRD08 administered by electroporation
Phase: 1
Study Start date:
January 25, 2024
Estimated Completion Date:
July 30, 2025

Study Description

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).

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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