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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings