Actively Recruiting
Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors
Led by West China Hospital · Updated on 2026-03-17
12
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years at the time of informed consent.
- Diagnosed with advanced malignant solid tumors such as non-small cell lung cancer or colorectal cancer confirmed by histology or cytology.
- Unable to receive or tolerate standard treatments, or have refused standard treatments, with positive expression of target antigens in tumor tissue.
- Have at least one measurable or evaluable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Predicted survival time of at least 3 months.
- Main organs functioning well, meeting specified laboratory criteria within 7 days before treatment.
- Men and women of childbearing potential agree to use effective contraception during the study and for 6 months after vaccination.
- Female cancer patients have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after vaccination.
- Have completed required washout periods from prior anti-tumor therapy, molecular targeted drugs, palliative radiotherapy, chest radiation, and major surgery as specified.
You will not qualify if you...
- History of other tumors in the past, except certain cured malignant tumors without recurrence for 5 years as determined by the investigator.
- Uncontrolled clinical diseases or major medical conditions that may interfere with consent, study results, or participant safety.
- Active autoimmune disease or history of autoimmune disease; asthma requiring bronchodilator intervention excludes participation.
- Allergy to the trial vaccine or any excipients, or history of severe allergic reactions.
- Contraindications to subcutaneous injections.
- Prior antitumor therapeutic vaccine or cellular immunotherapy.
- Participation in other drug or device clinical trials within 4 weeks before screening.
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressive agents within 14 days before first vaccine dose.
- Unresolved toxic effects from prior cancer therapy except certain mild conditions.
- Active infections such as tuberculosis, hepatitis B or C, or HIV.
- History of substance abuse or relevant psychological or social conditions.
- Received any vaccine other than the study vaccine within 30 days before study vaccine or plans to receive other vaccines during the study.
- Any other factor or medical condition deemed by the investigator to interfere with study participation or safety.
- Unwillingness or inability to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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