Health TrialsbyHealthPanel

Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors

ConditionsAdvanced Solid TumorsNeoplasm
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes)

    Biological/Vaccine

    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.

  • Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes)

    Biological/Vaccine

    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.

  • Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes)

    Biological/Vaccine

    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.

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Dose Level 1: 1×10^10 ExosomesExperimental treatment 1 intervention
Group B: Dose Level 2: 2.5×10^10 ExosomesExperimental treatment 1 intervention
Group C: Dose Level 3: 5×10^10 ExosomesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence 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)

Secondary outcomes

1

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
2

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
3

Overall Survival (OS)

Time from first administration to death from any cause

Time frame
Up to 24 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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