Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid T
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.
| Condition(s) | Advanced Solid Tumors, Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Age 18 to 65 years (inclusive) at screening, any gender. 2. 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. 3. Must have a primary lesion suitable for local injection, accessible by direct palpation or under ultrasound/CT image guidance. 4. At least one measurable lesion per RECIST v1.1 criteria. 5. ECOG performance status score of 0-2. 6. Expected survival ≥ 3 months. 7. Adequate organ function within 7 days prior to treatment: * Neutrophil count (NEUT#) ≥ 1.5×10\^9/L; Platelets (PLT) ≥ 80×10\^9/L; Hemoglobin ≥ 8 g/dL * AST, A |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | West China Hospital |
| Locations | Chengdu, Sichuan, China |
| Start date | 2026-05-10 |
| NCT ID | NCT07563972 |
| Official listing | https://clinicaltrials.gov/study/NCT07563972 |