Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 12:05 PM
Study NCT ID:
NCT02866006
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
Sponsor:
Cellid Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: