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Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors

NCT06927297 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-17

No results posted yet for this study

Summary

This study is a dose-escalation, prospective clinical trial to assess the safety, tolerability, and preliminary therapeutic efficacy of engineered mitochondria expressing specific tumor antigen in patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor Malignancies
  • Advanced Solid Malignancies

Interventions

BIOLOGICAL

Engineered mitochondrial vaccine

Participants were assigned to one of four dose-escalation groups (25 μg, 50 μg, 100 μg, or 200 μg per dose) and received subcutaneous injections of the engineered mitochondrial vaccine in a prime-boost schedule. The regimen consisted of 3 doses of primary immunization, 1 dose of boost immunization and subsequent personalized treatment.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2026-12-31
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927297 on ClinicalTrials.gov