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RECRUITING
NCT07572864
PHASE2

Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

Head and neck squamous cell carcinoma (HNSCC) presents a significant clinical challenge, as over 60% of patients are diagnosed at a locally advanced stage with a high risk of recurrence. Although the landmark KEYNOTE-689 trial established neoadjuvant immune checkpoint inhibitor (ICI) therapy as a new standard of care, the pathological complete response (pCR) rate remains unsatisfactory at only 3.0%, highlighting an urgent need for optimized combination strategies. This prospective, single-arm, single-center clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of a novel neoadjuvant and adjuvant regimen combining an engineered mitochondrial vaccine (IMP3-Mito) with ICIs for patients with resectable, IMP3-positive locally advanced HNSCC. The rationale is based on a "Prime-and-Release" synergistic mechanism: the engineered mitochondrial vaccine serves as a potent "natural adjuvant" to activate dendritic cells and prime tumor-specific T-cell responses against the IMP3 antigen, while the ICI subsequently releases the immune brakes within the tumor microenvironment. By integrating these two modalities, the study seeks to achieve deeper pathological responses and improve long-term survival, while simultaneously providing clinical evidence for the transformative potential of the mitochondrial engineering platform in overcoming the limitations of conventional tumor vaccines.

Official title: Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Engineered Mitochondrial Vaccine as Neoadjuvant and Adjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm, Single-Center Clinical Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-06-29

Completion Date

2028-05-01

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

Engineered Mitochondrial Vaccine (IMP3-Mito)

A vaccine targeting the IMP3 antigen, utilizing an engineered mitochondrial platform. Administered via subcutaneous injection.

DRUG

Immune checkpoint inhibitor (ICI)

PD-1 inhibitor administered via intravenous infusion to synergistic with the mitochondrial vaccine.

Locations (2)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China