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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Samsung Medical Center
Seoul, South Korea
Evaluate DLT with Clinical laboratory tests [Safety]
Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay
Time frame: 12th week from first injection (End of trial)
Incidence of Serious Adverse Events assessed with CTCAE [Safety]
Time frame: 12th week from first injection (End of trial)
Clinical laboratory tests
Blood chemistry, Serology
Time frame: Screening visit and every 2 weeks from first injection (up to 12th week)
12-lead ECG
Time frame: Screening visit and Termination visit (12th week from first injection)
Vital signs
Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature
Time frame: Every 2 weeks from first injection (up to 12th week)
Physical examination
Body weight
Time frame: Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)
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