Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC

Sponsor
West China Hospital
Study ID
NCT07572864
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Engineered Mitochondrial Vaccine (IMP3-Mito) — BIOLOGICAL
    A vaccine targeting the IMP3 antigen, utilizing an engineered mitochondrial platform. Administered via subcutaneous injection.
  • Immune checkpoint inhibitor (ICI) — DRUG
    PD-1 inhibitor administered via intravenous infusion to synergistic with the mitochondrial vaccine.

Study Details

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.

Key Dates

First listed
May 7, 2026
Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IMP3-Mito Vaccine plus ICI Combination Group
    Participants with resectable IMP3-positive LA-HNSCC will receive neoadjuvant engineered mitochondrial vaccine (IMP3-Mito) in combination with immune checkpoint inhibitors, followed by surgery and subsequent adjuvant combination therapy.

Primary Outcome Measure

Major Pathologic Response [ Time Frame: At the time of surgery (approximately 6 weeks after enrollment). ]

Central Contacts

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