NCT02866006

Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer

Open-label, Dose-escalation, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre Efficacy of BVAC-C in Patients With Multiple Metastatic Progressive or Recurrent HPV Type 16 or 18 Positive Cervical Cancer After Failure to Standard Care

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cellid Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts(Phase I, Phase II). Phase I study is Open-label, dose-escalation, multiple dosing study to evaluate the safety, tolerability, immune response and preliminary efficacy of BVAC-C in patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard care. 9\~18 patients will be enrolled In Phase IIa study, which Open-label, sequential assignment multiple dosing study, efficacy, immune response and safety will be evaluated. Total 21 patients will be enrolled in 3 groups.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
DRUG	BVAC-C	Autologous B cells and monocytes transfected with E6E7 gene of HPV
DRUG	Topotecan

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2016-08-15
• Last updated: 2022-10-12

Locations

1 site across 1 country: South Korea