Actively Recruiting
Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors
Led by West China Hospital · Updated on 2026-05-11
9
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase I clinical trial is to evaluate the safety and tolerability of intratumoral injection of mechanically reprogrammed macrophage-derived exosomes (MRMEs) in adults aged 18-65 years with advanced solid tumors who have failed, are ineligible for, or are intolerant of standard therapies.
CONDITIONS
Official Title
Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years (inclusive), any gender
- Histologically or cytologically confirmed advanced (unresectable or metastatic) solid tumors that have failed standard therapy, have no standard treatment options, or are intolerant to standard treatment
- Primary lesion suitable for local injection, accessible by direct palpation or ultrasound/CT guidance
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0-2
- Expected survival of at least 3 months
- Adequate organ function within 7 days prior to treatment, including neutrophil count 63 1.5x10^9/L; platelets 63 80x10^9/L; hemoglobin 63 8 g/dL; liver enzymes 64 2.5x upper limit of normal; total bilirubin 64 1.5x upper limit; albumin 63 2.8 g/dL; serum creatinine 64 1.5x upper limit or creatinine clearance > 60 ml/min; INR 64 1.5; APTT 64 1.5x upper limit
- Voluntary participation with signed informed consent and ability to comply with visits and procedures
You will not qualify if you...
- Contraindications to intratumoral injection such as inflammation, ulceration, severe bleeding tendency, or permanent body art at injection site
- History of other malignancies except certain cured cancers without recurrence for 5 years
- Active or history of autoimmune disease except stable Type 1 diabetes on insulin
- Anti-tumor vaccine within 4 weeks before first dose; live vaccines within 4 weeks before or during study; major surgery or severe trauma within 4 weeks before first dose
- Prior anti-tumor treatment toxicity not recovered to CTCAE v5.0 Grade 1 or better
- Serious medical conditions including heart dysfunction, ischemic heart disease, arrhythmia, poorly controlled diabetes, uncontrolled hypertension, low ejection fraction, or prolonged QTc
- Active tuberculosis or uncontrolled prior TB infection
- Hyperthyroidism or organic thyroid disease except controlled hypothyroidism
- Active infection or unexplained fever within 48 hours before first dose or systemic antibiotics within 1 week before consent
- Active hepatitis B or C infection, known HIV/AIDS
- Known neurological or psychiatric disorders
- History of drug or alcohol abuse within 3 months
- Pregnant or breastfeeding, or unwillingness to use contraception through 6 months after study
- Receipt of investigational drug within 4 weeks before first dose or enrollment in another interventional study
- Any other factors judged by investigator to affect study completion
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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