Effect of predosing versus slow administration of propofol on the dose required for anaesthetic induction and on physiologic variables in healthy dogs.
Mathieu Raillard, Emma J Love, Pamela J Murison
https://pubmed.ncbi.nlm.nih.gov/29661678Actively Recruiting
Phase 1
Age: 18Years - 65Years
All Genders
ID07563972
A Phase I Open-Label Dose-Escalation Study of Intratumoral Macrophage-Derived Exosomes With Mechanobiological Reprogramming in Adults With Advanced Solid Tumors
Led by West China Hospital · Updated on 2026-05-11
9
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 65 years with advanced solid tumors who have not responded to, cannot receive, or do not tolerate standard treatments. This phase I trial aims to evaluate the safety and tolerability of intratumoral injections of mechanobiologically reprogrammed macrophage-derived exosomes. The study is open-label and non-randomized, focusing on dose escalation to find a safe dose level. Participants receive injections of these specially prepared exosomes directly into their tumors every two weeks for four doses. Three dose levels are being tested: 1 x 10^10, 2.5 x 10^10, and 5 x 10^10 exosomes per injection. These exosomes are made from the participant's own blood cells, reprogrammed through a special process, and purified before injection. The study follows a 3+3 dose escalation design. During the trial, participants will be monitored closely for dose-limiting toxicities for about four weeks after the first dose. Researchers will also assess tumor response, progression-free survival, overall survival, and treatment-related side effects over several months up to two years. The total duration of participation depends on individual outcomes and follow-up schedules, with safety assessments continuing for six months post-treatment.
CONDITIONS
Brief Title
Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years (inclusive), any gender
- Histologically or cytologically confirmed advanced solid tumors that are unresectable or metastatic
- Tumors that have failed standard therapy, have no standard treatment options, or are intolerant to standard treatments
- Primary lesion accessible for local injection by palpation or imaging guidance
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG performance status score between 0 and 2
- Expected survival of at least 3 months
- Adequate organ function within 7 days before treatment, including specific blood counts, liver and kidney function, and coagulation parameters
- Voluntary participation with signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Contraindications to intratumoral injection such as inflammation, ulceration, severe bleeding tendency, or interfering body art at injection site
- History of other malignancies except certain cured or in situ cancers without recurrence for 5 years
- Active or history of autoimmune diseases excluding stable Type 1 diabetes on insulin
- Recent anti-tumor or live vaccinations, major surgery, or severe trauma within 4 weeks before treatment
- Unresolved prior anti-tumor treatment toxicity above CTCAE Grade 1
- Serious medical conditions including significant heart dysfunction, arrhythmia, poorly controlled diabetes, hypertension, or abnormal heart function measurements
- Active tuberculosis or uncontrolled prior TB infection
- Hyperthyroidism or organic thyroid disease except stable hypothyroidism
- Active infection, fever within 48 hours before treatment, or recent systemic antibiotics
- Active hepatitis B or C infections, known HIV positive or AIDS history
- Known neurological or psychiatric disorders
- History of drug or alcohol abuse within 3 months
- Pregnancy, breastfeeding, or unwillingness to use contraception during and 6 months post-study
- Receipt of investigational drugs within 4 weeks before treatment or enrollment in another interventional study
- Any other factors that may affect study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 weeks
Participants receive intratumoral injections of mechanobiologically reprogrammed macrophage-derived exosomes once every 2 weeks for 4 doses.
4 visits (in-person) every 2 weeks
Follow-up
Duration - Up to 6 months
Participants are monitored for safety and treatment outcomes including adverse events and tumor response for up to 6 months after treatment.
Periodic visits for safety assessments
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
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Research Team
X
Xingchen Peng
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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