Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors

May 6, 2026 updated by: Xingchen Peng, West China Hospital

A Phase I, Open-Label, Dose-Escalation Clinical Study to Evaluate the Safety and Tolerability of Intratumoral Administration of Macrophage-Derived Exosomes With Cellular Mechanobiological Reprogramming in Patients With Advanced Solid Tumors

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, ALT, ALP ≤ 2.5×ULN; Total bilirubin (TBIL) ≤ 1.5×ULN; Albumin ≥ 2.8 g/dL
    • Serum creatinine ≤ 1.5×ULN or CCR > 60 ml/min
    • INR ≤ 1.5; APTT ≤ 1.5×ULN
  8. Voluntarily participates, signs informed consent, and is able to comply with study visits and procedures.

Exclusion Criteria:

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. Prior anti-tumor treatment toxicity not recovered to ≤ CTCAE v5.0 Grade 1.
  6. Serious medical conditions: NYHA Class II or higher heart dysfunction, ischemic heart disease, significant arrhythmia, poorly controlled diabetes (fasting glucose ≥ 10 mmol/L), uncontrolled hypertension (SBP > 150 mmHg and/or DBP > 100 mmHg), LVEF < 50%, QTc > 450 ms (male) or > 470 ms (female).
  7. Active tuberculosis or uncontrolled prior TB infection.
  8. Hyperthyroidism or organic thyroid disease (except hypothyroidism controlled with stable thyroid hormone replacement).
  9. Active infection or unexplained fever within 48 hours before first dose, or systemic antibiotics within 1 week before informed consent.
  10. Active HBV (HBV DNA ≥ 2000 IU/ml or 10^4 copies/ml), active HCV (HCV antibody positive and HCV RNA above detection limit), or known HIV positive or AIDS history.
  11. Known neurological or psychiatric disorders (e.g., epilepsy, dementia).
  12. Known history of drug abuse or alcohol abuse within 3 months.
  13. Pregnant or breastfeeding women; participants (or their partners) planning pregnancy or unwilling to use contraception from screening to 6 months after study completion.
  14. Receipt of any investigational drug within 4 weeks before first dose, or concurrent enrollment in another interventional clinical study.
  15. Any other factors judged by the investigator that may affect study completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1: 1×10^10 Exosomes
Intratumoral injection of mechanobiologically reprogrammed macrophage-derived exosomes at a dose of 1×10^10 exosomes per injection, administered once every 2 weeks for 4 doses (3+3 dose escalation, Cohort 1).
Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (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 1×10^10 exosomes.
Experimental: Dose Level 2: 2.5×10^10 Exosomes
Intratumoral injection of mechanobiologically reprogrammed macrophage-derived exosomes at a dose of 2.5×10^10 exosomes per injection, administered once every 2 weeks for 4 doses (3+3 dose escalation, Cohort 2).
Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 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.
Experimental: Dose Level 3: 5×10^10 Exosomes
Intratumoral injection of mechanobiologically reprogrammed macrophage-derived exosomes at a dose of 5×10^10 exosomes per injection, administered once every 2 weeks for 4 doses (3+3 dose escalation, Cohort 3).
Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 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 5×10^10 exosomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: From first administration through Day 28 post-administration (approximately 4 weeks)
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).
From first administration through Day 28 post-administration (approximately 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 12 months
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Up to 12 months
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
Time from first administration to disease progression or death from any cause, assessed per RECIST v1.1
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
Time from first administration to death from any cause
Up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 6 months
Number and severity of adverse events graded per NCI CTCAE v5.0
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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