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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Autologous macrophage-derived exosomes prepared from the participant's own peripheral blood monocytes. Monocytes are isolated by apheresis, differentiated into macrophages, subjected to nuclear compression via a microfluidic device to induce mechanobiological reprogramming, and then exosomes are extracted and purified by ultracentrifugation. Administered via intratumoral injection once every 2 weeks for 4 doses at a dose of 1×10\^10 exosomes.
Autologous macrophage-derived exosomes prepared from the participant's own peripheral blood monocytes. Monocytes are isolated by apheresis, differentiated into macrophages, subjected to nuclear compression via a microfluidic device to induce mechanobiological reprogramming, and then exosomes are extracted and purified by ultracentrifugation. Administered via intratumoral injection once every 2 weeks for 4 doses at a dose of 2.5×10\^10 exosomes.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence of Dose-Limiting Toxicity (DLT)
DLT is defined as treatment-related adverse events graded per NCI CTCAE v5.0 occurring during the DLT observation period, including grade ≥4 hematologic toxicity or grade ≥3 non-hematologic toxicity (with exceptions).
Time frame: From first administration through Day 28 post-administration (approximately 4 weeks)
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time from first administration to disease progression or death from any cause, assessed per RECIST v1.1
Time frame: Up to 24 months
Overall Survival (OS)
Time from first administration to death from any cause
Time frame: Up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and severity of adverse events graded per NCI CTCAE v5.0
Time frame: Up to 6 months
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Autologous macrophage-derived exosomes prepared from the participant's own peripheral blood monocytes. Monocytes are isolated by apheresis, differentiated into macrophages, subjected to nuclear compression via a microfluidic device to induce mechanobiological reprogramming, and then exosomes are extracted and purified by ultracentrifugation. Administered via intratumoral injection once every 2 weeks for 4 doses at a dose of 5×10\^10 exosomes.