Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
Launched by GENEXINE, INC. · Mar 27, 2014
Trial Information
Current as of May 30, 2025
Unknown status
Keywords
ClinConnect Summary
This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.
Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.
The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female aged between 20 and 50 (inclusive)
- • The subjects who have visited within 48 weeks after final injection of GX-188E
- • Those who voluntarily signed informed consent form
- Exclusion Criteria:
- • Prior participation in any clinical trial within 30 days prior to the visit 1
- • Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
About Genexine, Inc.
Genexine, Inc. is a biopharmaceutical company focused on the development of innovative immunotherapeutic and gene therapy solutions for the treatment of cancer and rare diseases. With a commitment to advancing cutting-edge technologies, Genexine leverages its proprietary platform to create differentiated therapeutic candidates that aim to enhance patient outcomes. The company emphasizes rigorous clinical research and collaboration with global partners to bring novel treatments to market, demonstrating a steadfast dedication to addressing unmet medical needs and improving the lives of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, Korea, Korea, Republic Of
Patients applied
Trial Officials
Tae Jin Kim, M.D.
Principal Investigator
Cheil General Hospital & Women's Healthcare Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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