Advanced Solid TumorsPhase 1NCT07563972
Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors
A Phase 1 study testing Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes), Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes) and Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes) in people with Advanced Solid Tumors and Neoplasm, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Solid Tumors, Neoplasm
- What is being tested?
- Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes), Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes) and Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- ECOG performance status score of 0-2.
- Expected survival ≥ 3 months.
Show all 12Show fewer
- 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
- Voluntarily participates, signs informed consent, and is able to comply with study visits and procedures.
Who cannot join
- 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.
- Prior anti-tumor treatment toxicity not recovered to ≤ CTCAE v5.0 Grade 1.
- 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).
Show all 15Show fewer
- Active tuberculosis or uncontrolled prior TB infection.
- Hyperthyroidism or organic thyroid disease (except hypothyroidism controlled with stable thyroid hormone replacement).
- Active infection or unexplained fever within 48 hours before first dose, or systemic antibiotics within 1 week before informed consent.
- 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.
- Known neurological or psychiatric disorders (e.g., epilepsy, dementia).
- Known history of drug abuse or alcohol abuse within 3 months.
- Pregnant or breastfeeding women; participants (or their partners) planning pregnancy or unwilling to use contraception from screening to 6 months after study completion.
- Receipt of any investigational drug within 4 weeks before first dose, or concurrent enrollment in another interventional clinical study.
- Any other factors judged by the investigator that may affect study completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors, Neoplasm
- Being tested
- Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes), Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes), Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes)
- Keywords
- Macrophage, Exosomes, Mechanobiological Reprogramming, Microfluidics, Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes)Biological
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
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: 1×10^10 Exosomes | Experimental | 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). Receives: Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes) |
| Dose Level 2: 2.5×10^10 Exosomes | Experimental | 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). Receives: Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes) |
| Dose Level 3: 5×10^10 Exosomes | Experimental | 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). Receives: Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From first administration through Day 28 post-administration (approximately 4 weeks)
Secondary outcomes (4)
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Measured: 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
Measured: Up to 24 months
Overall Survival (OS)
Time from first administration to death from any cause
Measured: Up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and severity of adverse events graded per NCI CTCAE v5.0
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 May 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose escalation design with three sequential dose cohorts (1×10\^10, 2.5×10\^10, 5×10\^10 exosomes/dose). Each cohort enrolls 3 participants. Dose escalation proceeds based on DLT evaluation during the observation period (from first administration through Day 28 post-administration).
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563972
- Sponsor's protocol ID
- 2026-796
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raillard M, Love EJ, Murison PJ. Effect of predosing versus slow administration of propofol on the dose required for anaesthetic induction and on physiologic variables in healthy dogs. Vet Anaesth Analg. 2018 Jul;45(4):414-422. doi: 10.1016/j.vaa.2018.02.004. Epub 2018 Mar 6.
PubMed 29661678Alatrash N, Narh ES, Yadav A, Kim MJ, Janaratne T, Gabriel J, MacDonnell FM. Synthesis, DNA Cleavage Activity, Cytotoxicity, Acetylcholinesterase Inhibition, and Acute Murine Toxicity of Redox-Active Ruthenium(II) Polypyridyl Complexes. ChemMedChem. 2017 Jul 6;12(13):1055-1069. doi: 10.1002/cmdc.201700240. Epub 2017 Jun 12.
PubMed 28605571Okoye IS, Coomes SM, Pelly VS, Czieso S, Papayannopoulos V, Tolmachova T, Seabra MC, Wilson MS. MicroRNA-containing T-regulatory-cell-derived exosomes suppress pathogenic T helper 1 cells. Immunity. 2014 Jul 17;41(1):89-103. doi: 10.1016/j.immuni.2014.05.019.
PubMed 25035954Niu J, Liu Y. The Construction of English Smart Classroom Teaching Mode Based on Deep Learning. Comput Intell Neurosci. 2022 Aug 22;2022:9037010. doi: 10.1155/2022/9037010. eCollection 2022.
PubMed 36045993Piccolo S, Panciera T, Contessotto P, Cordenonsi M. YAP/TAZ as master regulators in cancer: modulation, function and therapeutic approaches. Nat Cancer. 2023 Jan;4(1):9-26. doi: 10.1038/s43018-022-00473-z. Epub 2022 Dec 23.
PubMed 36564601Wang H, Guo S, Kim SJ, Shao F, Ho JWK, Wong KU, Miao Z, Hao D, Zhao M, Xu J, Zeng J, Wong KH, Di L, Wong AH, Xu X, Deng CX. Cisplatin prevents breast cancer metastasis through blocking early EMT and retards cancer growth together with paclitaxel. Theranostics. 2021 Jan 1;11(5):2442-2459. doi: 10.7150/thno.46460. eCollection 2021.
PubMed 33500735Reiss KA, Angelos MG, Dees EC, Yuan Y, Ueno NT, Pohlmann PR, Johnson ML, Chao J, Shestova O, Serody JS, Schmierer M, Kremp M, Ball M, Qureshi R, Schott BH, Sonawane P, DeLong SC, Christiano M, Swaby RF, Abramson S, Locke K, Barton D, Kennedy E, Gill S, Cushing D, Klichinsky M, Condamine T, Abdou Y. CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial. Nat Med. 2025 Apr;31(4):1171-1182. doi: 10.1038/s41591-025-03495-z. Epub 2025 Feb 7.
PubMed 39920391Song Y, Soto J, Chen B, Yang L, Li S. Cell engineering: Biophysical regulation of the nucleus. Biomaterials. 2020 Mar;234:119743. doi: 10.1016/j.biomaterials.2019.119743. Epub 2020 Jan 3.
PubMed 31962231Kalukula Y, Stephens AD, Lammerding J, Gabriele S. Mechanics and functional consequences of nuclear deformations. Nat Rev Mol Cell Biol. 2022 Sep;23(9):583-602. doi: 10.1038/s41580-022-00480-z. Epub 2022 May 5.
PubMed 35513718Song Y, Soto J, Chen B, Hoffman T, Zhao W, Zhu N, Peng Q, Liu L, Ly C, Wong PK, Wang Y, Rowat AC, Kurdistani SK, Li S. Transient nuclear deformation primes epigenetic state and promotes cell reprogramming. Nat Mater. 2022 Oct;21(10):1191-1199. doi: 10.1038/s41563-022-01312-3. Epub 2022 Aug 4.
PubMed 35927431
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07563972
- Acronym / sponsor ID
- 2026-796
- Conditions
- Advanced Solid Tumors, Neoplasm
- Keywords
- Macrophage, Exosomes, Mechanobiological Reprogramming, Microfluidics, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3+3 dose escalation design with three sequential dose cohorts (1×10^10, 2.5×10^10, 5×10^10 exosomes/dose). Each cohort enrolls 3 participants. Dose escalation proceeds based on DLT evaluation during the observation period (from first administration through Day 28 post-administration).
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: 1×10^10 Exosomes | Experimental | Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (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). |
| Dose Level 2: 2.5×10^10 Exosomes | Experimental | Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (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). |
| Dose Level 3: 5×10^10 Exosomes | Experimental | Biological: Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- ECOG performance status score of 0-2.
Key exclusion criteria (15 listed)
- 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.
- Prior anti-tumor treatment toxicity not recovered to ≤ CTCAE v5.0 Grade 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Dose Level 1: 1×10^10 Exosomes |
| 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. | Biological | Dose Level 2: 2.5×10^10 Exosomes |
| 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. | Biological | Dose Level 3: 5×10^10 Exosomes |
Primary outcome
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).
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 29661678Raillard M, Love EJ, Murison PJ. Effect of predosing versus slow administration of propofol on the dose required for anaesthetic induction and on physiologic variables in healthy dogs. Vet Anaesth Analg. 2018 Jul;45(4):414-422. doi: 10.1016/j.vaa.2018.02.004. Epub 2018 Mar 6.
- Background: PubMed 28605571Alatrash N, Narh ES, Yadav A, Kim MJ, Janaratne T, Gabriel J, MacDonnell FM. Synthesis, DNA Cleavage Activity, Cytotoxicity, Acetylcholinesterase Inhibition, and Acute Murine Toxicity of Redox-Active Ruthenium(II) Polypyridyl Complexes. ChemMedChem. 2017 Jul 6;12(13):1055-1069. doi: 10.1002/cmdc.201700240. Epub 2017 Jun 12.
- Background: PubMed 25035954Okoye IS, Coomes SM, Pelly VS, Czieso S, Papayannopoulos V, Tolmachova T, Seabra MC, Wilson MS. MicroRNA-containing T-regulatory-cell-derived exosomes suppress pathogenic T helper 1 cells. Immunity. 2014 Jul 17;41(1):89-103. doi: 10.1016/j.immuni.2014.05.019.
- Background: PubMed 36045993Niu J, Liu Y. The Construction of English Smart Classroom Teaching Mode Based on Deep Learning. Comput Intell Neurosci. 2022 Aug 22;2022:9037010. doi: 10.1155/2022/9037010. eCollection 2022.
- Background: PubMed 36564601Piccolo S, Panciera T, Contessotto P, Cordenonsi M. YAP/TAZ as master regulators in cancer: modulation, function and therapeutic approaches. Nat Cancer. 2023 Jan;4(1):9-26. doi: 10.1038/s43018-022-00473-z. Epub 2022 Dec 23.
- Background: PubMed 33500735Wang H, Guo S, Kim SJ, Shao F, Ho JWK, Wong KU, Miao Z, Hao D, Zhao M, Xu J, Zeng J, Wong KH, Di L, Wong AH, Xu X, Deng CX. Cisplatin prevents breast cancer metastasis through blocking early EMT and retards cancer growth together with paclitaxel. Theranostics. 2021 Jan 1;11(5):2442-2459. doi: 10.7150/thno.46460. eCollection 2021.
- Background: PubMed 39920391Reiss KA, Angelos MG, Dees EC, Yuan Y, Ueno NT, Pohlmann PR, Johnson ML, Chao J, Shestova O, Serody JS, Schmierer M, Kremp M, Ball M, Qureshi R, Schott BH, Sonawane P, DeLong SC, Christiano M, Swaby RF, Abramson S, Locke K, Barton D, Kennedy E, Gill S, Cushing D, Klichinsky M, Condamine T, Abdou Y. CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial. Nat Med. 2025 Apr;31(4):1171-1182. doi: 10.1038/s41591-025-03495-z. Epub 2025 Feb 7.
- Background: PubMed 31962231Song Y, Soto J, Chen B, Yang L, Li S. Cell engineering: Biophysical regulation of the nucleus. Biomaterials. 2020 Mar;234:119743. doi: 10.1016/j.biomaterials.2019.119743. Epub 2020 Jan 3.
- Background: PubMed 35513718Kalukula Y, Stephens AD, Lammerding J, Gabriele S. Mechanics and functional consequences of nuclear deformations. Nat Rev Mol Cell Biol. 2022 Sep;23(9):583-602. doi: 10.1038/s41580-022-00480-z. Epub 2022 May 5.
- Background: PubMed 35927431Song Y, Soto J, Chen B, Hoffman T, Zhao W, Zhu N, Peng Q, Liu L, Ly C, Wong PK, Wang Y, Rowat AC, Kurdistani SK, Li S. Transient nuclear deformation primes epigenetic state and promotes cell reprogramming. Nat Mater. 2022 Oct;21(10):1191-1199. doi: 10.1038/s41563-022-01312-3. Epub 2022 Aug 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (1×10^10 exosomes), Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (2.5×10^10 exosomes) and Mechanobiologically Reprogrammed Macrophage-Derived Exosomes (5×10^10 exosomes) in people with Advanced Solid Tumors and Neoplasm, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: From first administration through Day 28 post-administration (approximately 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07563972, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.