Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years, both genders eligible.
Clinical stage II-IVB according to the AJCC 8th Edition (nasopharyngeal carcinoma is excluded);
Positive expression of IMP3 protein;
Clinically resectable as determined by a Multidisciplinary Team (MDT);
Disqualifiers
History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal carcinoma, or other malignancies that the investigator deems eligible.
Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (except for Type I diabetes mellitus on a stable dose of insulin).
Active inflammation, trauma, or skin breakdown at the intended injection site;
Severe bleeding or coagulation tendency, or significantly reduced platelets/clotting factors assessed by the investigator as high risk for bleeding;
Trial design
Design model
Single group
Treatments tested in this trial
Engineered Mitochondrial Vaccine (IMP3-Mito)
Biological/VaccineA vaccine targeting the IMP3 antigen, utilizing an engineered mitochondrial platform. Administered via subcutaneous injection.
Immune checkpoint inhibitor (ICI)
DrugPD-1 inhibitor administered via intravenous infusion to synergistic with the mitochondrial vaccine.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: IMP3-Mito Vaccine plus ICI Combination GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Major Pathologic Response
Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.
Time frame
At the time of surgery (approximately 6 weeks after enrollment).Secondary outcomes
1
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the product was also an AE. The number of participants who experienced an AE was reported for each arm.
Time frame
From the first dose until the completion of the 12-month post-operative follow-up (approximately 14 months in total).2
Pathologic Complete Response
Pathologic Complete Response (pCR) was defined as the absence of viable tumor cells.
Time frame
At the time of surgery (approximately 6 weeks after enrollment).3
Objective Response Rate
Objective Response Rate (ORR) was defined as the percentage of participants with a best overall response of CR or PR using RECIST Criteria.
Time frame
From the start of neoadjuvant therapy to the end of neoadjuvant therapy, the duration is approximately 2 monthsSponsors and contacts
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Source ClinicalTrials.gov