RecruitingPhase 1Phase 2NCT06797986

A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.

A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects With HPV Type 16 and/or 18 Positive Unresectable Recurrent or Metastatic Head

Sponsor

Cellid Co., Ltd.

Enrollment

37 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)HPV Positive Oropharyngeal Squamous Cell Carcinoma HPV (Human Papillomavirus)-Associated Carcinoma

Summary

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BVAC-E6E7 (RP2D), a biological treatment called BVAC-E6E7 (high level), and others for people with hpv (human papillomavirus)-associated carcinoma, hpv positive oropharyngeal squamous cell carcinoma, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBVAC-E6E7 (low level)

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.

BIOLOGICALBVAC-E6E7 (high level)

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.

BIOLOGICALBVAC-E6E7 (RP2D)

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.

Locations(2)

Seoul National Univesity Hospital

Seoul, South Korea

Sevrance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06797986

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