Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 65 years (inclusive) at screening, any gender.
Histologically or cytologically confirmed advanced (unresectable or metastatic) solid tumors (including melanoma, soft tissue sarcoma, head and neck squamous cell carcinoma, etc.) that have failed standard therapy, have no standard treatment options, or are intolerant to standard treatment.
Must have a primary lesion suitable for local injection, accessible by direct palpation or under ultrasound/CT image guidance.
At least one measurable lesion per RECIST v1.1 criteria.
Disqualifiers
Contraindications to intratumoral injection: inflammation or ulceration at injection site; severe bleeding tendency; abnormal or permanent body art (e.g., tattoos) at injection site interfering with local reaction observation.
History of other malignancies (except cured basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, cervical carcinoma in situ, intramucosal gastrointestinal cancer without recurrence for 5 years).
Active autoimmune disease or history of autoimmune disease (including but not limited to immune-related neuropathy, multiple sclerosis, autoimmune neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective tissue disease, scleroderma, IBD, autoimmune hepatitis, TEN, or Stevens-Johnson syndrome); except Type 1 diabetes on stable insulin dose.
Anti-tumor vaccine within 4 weeks before first dose; live vaccines within 4 weeks before or during the study; major surgery or severe trauma within 4 weeks before first dose.
Trial design
Treatments tested in this trial
- Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes)
- Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes)
- Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes)
Treatment groups
9 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov