RecruitingPhase 1NCT06927297

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

A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of an Engineered Mitochondrial Vaccine in Treatment of Advanced Solid Tumors


Sponsor

West China Hospital

Enrollment

12 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Engineered mitochondrial vaccine for people with advanced solid malignancies and advanced solid tumor malignancies. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

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

BIOLOGICALEngineered 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.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06927297


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