Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)

BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose)

BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks

Autologous B cells and monocytes transfected with E6E7 gene of HPV

BVAC-C

C Y Kang, PH.D

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.

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

Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay

Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer	NCT02866006	Uterine Cervica...	BVAC-C Topotecan	20 Years -	Cellid Co., Ltd.
Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer	NCT02866006	Uterine Cervica...	BVAC-C Topotecan	20 Years -	Cellid Co., Ltd.

Spots Global Cancer Trial Database for immune therapeutic vaccine