Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
NCT02866006 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2022-10-12
Summary
BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts. Phase I is for safety evaluation, and Phase IIa is for efficacy assessment.
Conditions
- Uterine Cervical Neoplasms
Interventions
- DRUG
-
BVAC-C
Autologous B cells and monocytes transfected with E6E7 gene of HPV
- DRUG
-
Topotecan
Sponsors & Collaborators
-
Cellid Co., Ltd.
lead INDUSTRY
Principal Investigators
-
C Y Kang, PH.D · Seoul National University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2021-12-31
- Completion
- 2022-06-30
Countries
- South Korea
Study Locations
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