Mesothelin-Positive Advanced Solid Tumors With Peritoneal MetastasisPhase 1NCT07909434
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
A Phase 1 study testing SY001 in people with Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis, run by Zhejiang University.
Trial summary
An exploratory, open-label, single-arm, dose-escalation clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity of intraperitoneally administered SY001 (mesothelin-targeted autologous CAR-Mix cells) in participants with mesothelin-positive advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
- What is being tested?
- SY001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 75 years, inclusive.
- Histologically and/or pathologically confirmed advanced, metastatic, or recurrent malignant solid tumor with peritoneal metastasis, with or without distant metastases, with complete pathological documentation available. Eligible participants include those who have failed second-line or later standard therapy; have no available standard therapy; have failed available therapy; or, based on a comprehensive benefit-risk assessment by the investigator considering prior treatment-related toxicities, current performance status, comorbidities, and organ function, are considered unsuitable for further available standard therapy. Tumor types may include, but are not limited to, gastric cancer, colorectal cancer, fallopian tube cancer, and mesothelioma. Relevant toxicities from prior therapy must have recovered to Grade ≤1 during screening or returned to baseline before the first administration, unless otherwise judged by the investigator to pose no safety risk.
- At least one measurable lesion according to RECIST Version 1.1, defined as a non-lymph-node lesion with a longest diameter ≥10 mm or a lymph node with a short-axis diameter ≥15 mm by CT or MRI, with a scan slice thickness ≤5 mm.
- Mesothelin-positive tumor as confirmed by immunohistochemistry (IHC) or immunocytochemistry (ICC), defined as Mesothelin expression in ≥10% of tumor cells.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic, hepatic, renal, and coagulation function meeting all of the following criteria:
Show all 19Show fewer
- White blood cell count (WBC) ≥2.0 × 10^9/L;
- Absolute neutrophil count (ANC) ≥1.2 × 10^9/L;
- Platelet count ≥70 × 10^9/L;
- Hemoglobin ≥80 g/L;
- Total bilirubin ≤1.5 × the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN, or ≤5.0 × ULN in participants with liver metastases;
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN in participants not receiving anticoagulant therapy.
- No bleeding disorder or coagulation disorder.
- Toxicities from prior treatment must have recovered to Grade ≤1 according to NCI CTCAE Version 5.0 or returned to baseline, except for toxicities considered by the investigator not to pose a safety risk.
- Estimated life expectancy of at least 3 months.
- From screening until at least 12 months after intraperitoneal infusion of SY001, participants and their partners must have no plans for conception and must agree to use effective non-pharmacological contraceptive measures during the study, such as condoms or a non-medicated intrauterine device, unless permanent contraception has already been performed (e.g., bilateral tubal ligation or vasectomy).
- Ability and willingness to provide written informed consent and comply with all study procedures and requirements.
Who cannot join
- Severe cardiovascular or cerebrovascular disease, including, but not limited to, any of the following:
- Acute myocardial infarction, unstable angina, stroke, coronary angioplasty, or coronary stent placement within 6 months before screening;
- New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) <50%;
- Uncontrolled hypertension despite optimal medical therapy, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- Arrhythmia of greater than Grade 2 according to NCI CTCAE Version 5.0;
- Corrected QT (QTc) interval >480 ms on screening electrocardiogram.
Show all 25Show fewer
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ≤60% before enrollment or requirement for supplemental oxygen.
- Uncontrolled active infection. Prophylactic antibacterial, antiviral, and antifungal therapy is permitted.
- Positive syphilis TRUST test; positive anti-HIV antibody; positive anti-HCV antibody with HCV RNA above the lower limit of detection; or positive hepatitis B core antibody (HBcAb) with HBV DNA above the lower limit of detection.
- Receipt of a live attenuated vaccine within 4 weeks before screening.
- Any contraindication to intraperitoneal administration, including extensive intra-abdominal adhesions, complete intestinal obstruction, or severe intra-abdominal infection; or intestinal obstruction, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, severe gastroduodenal ulcer, severe ulcerative colitis, or other severe gastrointestinal inflammatory disease.
- Known history of significant drug allergy or hypersensitivity to heterologous proteins, biological products, or any component of the study product.
- Symptomatic central nervous system metastases or leptomeningeal metastases, or uncontrolled systemic or leptomeningeal metastatic disease considered by the investigator to make the participant unsuitable for enrollment.
- History of autoimmune disease, including but not limited to epilepsy, systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, or autoimmune hepatitis.
- History of substance abuse that cannot be discontinued or a history of psychiatric disorders.
- Receipt of any immune cell therapy within 6 months before screening.
- Prior Mesothelin-targeted therapy, including investigational Mesothelin-targeted treatment.
- Current use of, or use within 14 days before the first administration of the study product, systemic immunomodulatory agents or systemic corticosteroids at a dose equivalent to prednisone >10 mg/day.
- Receipt of chemotherapy, targeted therapy, or another investigational anticancer agent within 14 days or within at least 5 half-lives before screening, whichever period is shorter.
- History of Grade ≥2 immune-related adverse events involving major organs induced by prior or current immune checkpoint inhibitor therapy, including but not limited to myocarditis or central nervous system toxicity.
- Participation in another drug clinical trial within 4 weeks before screening.
- Surgery within 2 weeks before mononuclear cell collection that, in the investigator's judgment, may affect participant safety.
- Pregnant or breastfeeding women.
- Any other disease or medical condition that may increase the participant's risk or interfere with interpretation of the study results.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory, Single-Arm, Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Mesothelin-Targeted CAR-Mix Cells in Participants With Advanced Solid Tumors
An exploratory, open-label, single-arm, dose-escalation clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity of intraperitoneally administered SY001 (mesothelin-targeted autologous CAR-Mix cells) in participants with mesothelin-positive advanced solid tumors with peritoneal metastasis
Read the detailed description
Mesothelin (MSLN) is a cell-surface glycoprotein with limited expression in normal tissues and overexpression in multiple solid tumors. Its tumor-associated expression makes MSLN a potential target for cellular immunotherapy. However, the efficacy of cellular therapies in solid tumors may be limited by tumor heterogeneity and an immunosuppressive tumor microenvironment.
SY001 is an autologous MSLN-targeted CAR-Mix cell product generated from peripheral blood mononuclear cells. The final product consists predominantly of chimeric antigen receptor-modified macrophages (CAR-M) and contains T cells accounting for at least 15% of the total cell count. The CAR-M component is intended to recognize MSLN-positive tumor cells, enhance phagocytosis and antigen presentation, and modulate the tumor microenvironment, while the T-cell component may provide complementary antitumor activity. Preclinical studies showed specific tumor-cell killing in vitro and antitumor activity following intraperitoneal administration in a xenograft model.
This study will enroll 10 to 24 participants aged 18 to 75 years with MSLN-positive advanced solid tumors with peritoneal metastasis. Four planned dose levels of SY001 (1×10⁹, 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells) will be evaluated using an accelerated-titration strategy followed by a 3+3 dose-escalation design. The primary objective is to evaluate safety and tolerability during the 28-day dose-limiting toxicity (DLT) observation period and to determine the maximum tolerated dose (MTD). Secondary and exploratory objectives include preliminary antitumor activity, pharmacokinetic and pharmacodynamic characteristics, and relationships among MSLN expression, changes in the immune microenvironment, and clinical outcomes. Tumor response will be assessed using RECIST 1.1, with malignant ascites assessed according to the protocol-defined WHO criteria.
- Being tested
- SY001
- Keywords
- MSLN, CAR-M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY001Biological
SY001 is an autologous, mesothelin-targeted CAR-Mix cell product manufactured from peripheral blood mononuclear cells collected following G-CSF mobilization and leukapheresis. The final product consists predominantly of CAR-engineered macrophages (CAR-M) and contains T cells accounting for at least 15% of the total cell population. Participants will receive SY001 by intraperitoneal infusion at the assigned dose level. The planned dose levels are 1×10⁹, 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells. For participants with malignant ascites, ascitic fluid will be drained as completely as clinically feasible before SY001 infusion. For participants without malignant ascites, SY001 will be infused with 100 mL of normal saline through an intraperitoneal catheter within approximately 30 minutes. The catheter will be flushed with normal saline before and after cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated titration dose exploration phase | Experimental | Participants will receive SY001 at a starting dose of 1×10⁹ CAR-Mix cells by intraperitoneal infusion. The actual administered cell dose is allowed to vary by ±30% due to the characteristics of autologous cell manufacturing. One participant will initially be enrolled at this dose level. If the participant does not experience any Grade 2 or higher adverse event during the 28-day dose-limiting toxicity (DLT) observation period, dose escalation will proceed to the next dose level and subsequent dose exploration will follow the conventional "3+3" design. If the initial participant experiences a Grade 2 or higher adverse event, two additional participants will be enrolled at the same dose level, and dose escalation will thereafter proceed according to the "3+3" design. Receives: Biological: SY001 |
| "3+3" dose escalation phase | Experimental | Following completion of the accelerated titration phase, dose escalation will proceed sequentially through three planned dose levels: 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells administered by intraperitoneal infusion. The actual administered cell dose at each dose level is allowed to vary by ±30%. Each dose cohort will initially enroll 3 participants. For safety, the first participant at each new dose level will be observed for 7 days after infusion before additional participants are enrolled at that dose level.If no DLT is observed among the initial 3 participants during the 28-day DLT observation period, escalation to the next dose level will proceed. If 1 of the initial 3 participants experiences a DLT, the cohort will be expanded to 6 participants. If no additional DLT occurs among the 3 additional participants, escalation to the next dose level may proceed. If 2 or more participants experience a DLT at a given dose level, dose escalation will be stopped and the preceding lower dose Receives: Biological: SY001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
DLTs are defined as protocol-specified treatment-related hematologic or non-hematologic toxicities occurring during the 28-day DLT observation period.
Measured: Day 1 through Day 28 after SY001 infusion
Maximum Tolerated Dose (MTD) of SY001
The MTD is defined as the highest dose level at which no more than 1 of 6 evaluable participants experiences a DLT. If the MTD is not reached at the highest planned dose level and no further dose escalation is pursued, the highest evaluated dose may be designated as the MTD according to the protocol.
Measured: During the dose-escalation phase, based on DLTs occurring from Day 1 through Day 28 after infusion.
Secondary outcomes (15)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST Version 1.1.
Measured: 6 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve a best overall response of CR, PR, or stable disease (SD), as assessed according to RECIST Version 1.1.
Measured: 12 months
Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR until the first documented disease progression or death from any cause, whichever occurs first.
Measured: 12 months
Progression-Free Survival (PFS)
PFS is defined as the time from the first SY001 infusion to the first documented disease progression or death from any cause, whichever occurs first.
Measured: 12 months
Overall Survival (OS)
OS is defined as the time from the first SY001 infusion to death from any cause.
Measured: 24 months
Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Cmax)
Cmax is defined as the maximum observed CAR-Mix copy number in peripheral blood following SY001 infusion, determined from serial blood samples collected at protocol-specified time points.
Measured: 28 days
Time to Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Tmax)
Tmax is defined as the elapsed time from SY001 infusion to the time at which the maximum CAR-Mix copy number is observed in peripheral blood. Tmax will be expressed in days.
Measured: 28 days
Area Under the CAR-Mix Copy Number-Time Curve From 0 to Tmax in Peripheral Blood (AUC 0-Tmax)
AUC 0-Tmax is defined as the area under the CAR-Mix copy number-time curve in peripheral blood from the time of SY001 infusion to the time of maximum observed copy number (Tmax).
Measured: 28 days
Change from Baseline in IL-1β (pg/mL) Concentration
The concentration of interleukin-1 beta (IL-1β) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Change from Baseline in IL-2 (pg/mL) Concentration
The concentration of interleukin-2 (IL-2) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Change from Baseline in IL-6 (pg/mL) Concentration
The concentration of interleukin-6 (IL-6) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Change from Baseline in IL-10 (pg/mL) Concentration
The concentration of interleukin-10 (IL-10) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Change from Baseline in TNF-α (pg/mL) Concentration
The concentration of tumor necrosis factor-alpha (TNF-α) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Change from Baseline in IFN-γ (pg/mL) Concentration
The concentration of interferon-gamma (IFN-γ) will be measured in peripheral blood serum and, when available, ascites supernatant using the protocol-specified cytokine assay. Changes from baseline will be evaluated following SY001 infusion.
Measured: 28 days
Incidence of Anti-SY001/CAR-Mix Antibodies
Immunogenicity will be evaluated by assessing anti-CAR-Mix antibodies (anti-drug antibodies [ADA]) in peripheral blood and, when available, ascites.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelin-Positive Advanced Solid Tumors With Peritoneal MetastasisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- CellOrigin Biotech (Hangzhou) Co., Ltd.
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia Fang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909434
- Sponsor's protocol ID
- CARMix-MSLN
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-Arm, Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Mesothelin-Targeted CAR-Mix Cells in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07909434
- Acronym / sponsor ID
- CARMix-MSLN
- Keywords
- MSLN, CAR-M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- CellOrigin Biotech (Hangzhou) Co., Ltd.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 2 Nov 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.
An exploratory, open-label, single-arm, dose-escalation clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity of intraperitoneally administered SY001 (mesothelin-targeted autologous CAR-Mix cells) in participants with mesothelin-positive advanced solid tumors with peritoneal metastasis
Detailed description
Mesothelin (MSLN) is a cell-surface glycoprotein with limited expression in normal tissues and overexpression in multiple solid tumors. Its tumor-associated expression makes MSLN a potential target for cellular immunotherapy. However, the efficacy of cellular therapies in solid tumors may be limited by tumor heterogeneity and an immunosuppressive tumor microenvironment.
SY001 is an autologous MSLN-targeted CAR-Mix cell product generated from peripheral blood mononuclear cells. The final product consists predominantly of chimeric antigen receptor-modified macrophages (CAR-M) and contains T cells accounting for at least 15% of the total cell count. The CAR-M component is intended to recognize MSLN-positive tumor cells, enhance phagocytosis and antigen presentation, and modulate the tumor microenvironment, while the T-cell component may provide complementary antitumor activity. Preclinical studies showed specific tumor-cell killing in vitro and antitumor activity following intraperitoneal administration in a xenograft model.
This study will enroll 10 to 24 participants aged 18 to 75 years with MSLN-positive advanced solid tumors with peritoneal metastasis. Four planned dose levels of SY001 (1×10⁹, 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells) will be evaluated using an accelerated-titration strategy followed by a 3+3 dose-escalation design. The primary objective is to evaluate safety and tolerability during the 28-day dose-limiting toxicity (DLT) observation period and to determine the maximum tolerated dose (MTD). Secondary and exploratory objectives include preliminary antitumor activity, pharmacokinetic and pharmacodynamic characteristics, and relationships among MSLN expression, changes in the immune microenvironment, and clinical outcomes. Tumor response will be assessed using RECIST 1.1, with malignant ascites assessed according to the protocol-defined WHO criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated titration dose exploration phase | Experimental | Biological: SY001Participants will receive SY001 at a starting dose of 1×10⁹ CAR-Mix cells by intraperitoneal infusion. The actual administered cell dose is allowed to vary by ±30% due to the characteristics of autologous cell manufacturing. One participant will initially be enrolled at this dose level. If the participant does not experience any Grade 2 or higher adverse event during the 28-day dose-limiting toxicity (DLT) observation period, dose escalation will proceed to the next dose level and subsequent dose exploration will follow the conventional "3+3" design. If the initial participant experiences a Grade 2 or higher adverse event, two additional participants will be enrolled at the same dose level, and dose escalation will thereafter proceed according to the "3+3" design. |
| "3+3" dose escalation phase | Experimental | Biological: SY001Following completion of the accelerated titration phase, dose escalation will proceed sequentially through three planned dose levels: 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells administered by intraperitoneal infusion. The actual administered cell dose at each dose level is allowed to vary by ±30%. Each dose cohort will initially enroll 3 participants. For safety, the first participant at each new dose level will be observed for 7 days after infusion before additional participants are enrolled at that dose level.If no DLT is observed among the initial 3 participants during the 28-day DLT observation period, escalation to the next dose level will proceed. If 1 of the initial 3 participants experiences a DLT, the cohort will be expanded to 6 participants. If no additional DLT occurs among the 3 additional participants, escalation to the next dose level may proceed. If 2 or more participants experience a DLT at a given dose level, dose escalation will be stopped and the preceding lower dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female participants aged 18 to 75 years, inclusive.
- Histologically and/or pathologically confirmed advanced, metastatic, or recurrent malignant solid tumor with peritoneal metastasis, with or without distant metastases, with complete pathological documentation available. Eligible participants include those who have failed second-line or later standard therapy; have no available standard therapy; have failed available therapy; or, based on a comprehensive benefit-risk assessment by the investigator considering prior treatment-related toxicities, current performance status, comorbidities, and organ function, are considered unsuitable for further available standard therapy. Tumor types may include, but are not limited to, gastric cancer, colorectal cancer, fallopian tube cancer, and mesothelioma. Relevant toxicities from prior therapy must have recovered to Grade ≤1 during screening or returned to baseline before the first administration, unless otherwise judged by the investigator to pose no safety risk.
- At least one measurable lesion according to RECIST Version 1.1, defined as a non-lymph-node lesion with a longest diameter ≥10 mm or a lymph node with a short-axis diameter ≥15 mm by CT or MRI, with a scan slice thickness ≤5 mm.
- Mesothelin-positive tumor as confirmed by immunohistochemistry (IHC) or immunocytochemistry (ICC), defined as Mesothelin expression in ≥10% of tumor cells.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (25 listed)
- Severe cardiovascular or cerebrovascular disease, including, but not limited to, any of the following:
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ≤60% before enrollment or requirement for supplemental oxygen.
- Uncontrolled active infection. Prophylactic antibacterial, antiviral, and antifungal therapy is permitted.
- Positive syphilis TRUST test; positive anti-HIV antibody; positive anti-HCV antibody with HCV RNA above the lower limit of detection; or positive hepatitis B core antibody (HBcAb) with HBV DNA above the lower limit of detection.
- Receipt of a live attenuated vaccine within 4 weeks before screening.
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 |
|---|---|---|
| SY001SY001 is an autologous, mesothelin-targeted CAR-Mix cell product manufactured from peripheral blood mononuclear cells collected following G-CSF mobilization and leukapheresis. The final product consists predominantly of CAR-engineered macrophages (CAR-M) and contains T cells accounting for at least 15% of the total cell population. Participants will receive SY001 by intraperitoneal infusion at the assigned dose level. The planned dose levels are 1×10⁹, 2×10⁹, 4×10⁹, and 6×10⁹ CAR-Mix cells. For participants with malignant ascites, ascitic fluid will be drained as completely as clinically feasible before SY001 infusion. For participants without malignant ascites, SY001 will be infused with 100 mL of normal saline through an intraperitoneal catheter within approximately 30 minutes. The catheter will be flushed with normal saline before and after cell infusion. | Biological | "3+3" dose escalation phase, Accelerated titration dose exploration phase |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 28 after SY001 infusion
DLTs are defined as protocol-specified treatment-related hematologic or non-hematologic toxicities occurring during the 28-day DLT observation period.
Maximum Tolerated Dose (MTD) of SY001
Time frame: During the dose-escalation phase, based on DLTs occurring from Day 1 through Day 28 after infusion.
The MTD is defined as the highest dose level at which no more than 1 of 6 evaluable participants experiences a DLT. If the MTD is not reached at the highest planned dose level and no further dose escalation is pursued, the highest evaluated dose may be designated as the MTD according to the protocol.
15 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 months
Disease Control Rate (DCR)
Time frame: 12 months
Duration of Response (DOR)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 months
Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Cmax)
Time frame: 28 days
Time to Maximum Observed CAR-Mix Copy Number in Peripheral Blood (Tmax)
Time frame: 28 days
Area Under the CAR-Mix Copy Number-Time Curve From 0 to Tmax in Peripheral Blood (AUC 0-Tmax)
Time frame: 28 days
Change from Baseline in IL-1β (pg/mL) Concentration
Time frame: 28 days
Change from Baseline in IL-2 (pg/mL) Concentration
Time frame: 28 days
Change from Baseline in IL-6 (pg/mL) Concentration
Time frame: 28 days
Change from Baseline in IL-10 (pg/mL) Concentration
Time frame: 28 days
Change from Baseline in TNF-α (pg/mL) Concentration
Time frame: 28 days
Change from Baseline in IFN-γ (pg/mL) Concentration
Time frame: 28 days
Incidence of Anti-SY001/CAR-Mix Antibodies
Time frame: 12 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 2 Nov 2026.
- Individual participant dataSharing planned: No
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.
Weijia Fang, MD principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SY001 in people with Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis, run by Zhejiang University.
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 19 inclusion and 25 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Weijia Fang, MD (+86-0571-87237587, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Day 1 through Day 28 after SY001 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.