A Phase 1 interventional study of SY001 in Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis, sponsored by Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment
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
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate hematologic, hepatic, renal, and coagulation function meeting all of the following criteria:
Exclusion Criteria:
Severe cardiovascular or cerebrovascular disease, including, but not limited to, any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: SY001
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
Biological: SY001
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.
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.
Time frame: 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.
Time frame: During the dose-escalation phase, based on DLTs occurring from Day 1 through Day 28 after infusion.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Overall Survival (OS)
OS is defined as the time from the first SY001 infusion to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Changes in the Immune Microenvironment
Changes in immune cell phenotypes and immune cell subsets in peripheral blood and, when available, ascites and tumor tissues will be explored using single-cell profiling and other protocol-specified immune analyses.
Time frame: 6 months
Correlation Between Baseline Mesothelin Expression and Best Percentage Change in Target Lesion Size
The Spearman rank correlation coefficient (rho) will be calculated to evaluate the correlation between baseline mesothelin (MSLN) expression and antitumor response. Baseline MSLN expression will be measured as the percentage of MSLN-positive tumor cells (%) using immunohistochemistry (IHC). Antitumor response will be measured as the best percentage change from baseline in the sum of target lesion diameters (%), assessed by CT according to RECIST Version 1.1 during the first 12 months following SY001 infusion. Only participants with evaluable baseline MSLN expression and post-baseline tumor measurements will be included.
Time frame: 12 months
Tumor Infiltration of CAR-Mix Cells
When tumor biopsy samples are available, infiltration of CAR-Mix cells into tumor tissue and associated changes in the tumor immune microenvironment will be explored.
Time frame: 24 months
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Plan to share: No
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Start is estimated for Nov 2026; primary completion for Jun 2029, 31 months later.
Of 210 non-industry phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 98. This study's planned 31 months is below that.
Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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