Treatment Related CancerNCT06562647
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
A study testing SY001 in people with Treatment Related Cancer and Ovarian Cancer, run by Cell Origin Biotech (Hangzhou) Co., Ltd. at 2 sites in China.
Trial summary
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Treatment Related Cancer, Ovarian Cancer
- 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
- 2 participants
- Where
- 2 sitesChina
- Study dates
- 12 Apr 2023to Dec 2027
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
- According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
- Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
- Estimated life expectancy >3 months;
- Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.
Who cannot join
- Pregnant or lactating women;
- Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
- Patients who have a history of other mesothelin-targeting therapy;
- Patients who have a history of autoimmune disease;
- The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jianhua Qian, PHD, 17816142153, qianjianhua@zju.edu.cn
- Not yet recruiting
Linyi Cancer Hospital
Linyi
Xiumin Li, +86 18868115772, Lyzlyylxm@163.com
About this study
Official title: An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
Read the detailed description
This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.
- Conditions
- Treatment Related Cancer, Ovarian Cancer
- Being tested
- SY001
- Medical subject headings
- Neoplasms, Second Primary, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY001Drug
Also called CAR-pMAC
PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages
| Study group | Role | What they receive |
|---|---|---|
| SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting | Experimental | Patients with mesothelin-positive ovarian cancer were treated with an SY001 injection in combination with an anti-PD-1 antibody. Patient 001 received 1109 SY001 CAR-pMACs via intravenous injection. Following a two-month period in which the treatment's safety was confirmed, this patient underwent another two does of 1109 SY001 cells on both day 1 and day 3. Prior to the CAR-pMACs infusion on day 1, a PD1 antibody Tislelizumab Injection was administered. In the case of the patient 002, SY001 treatment was delivered intravenously on three occasions: day 1, day 3, and day 5. The same as the first patient's protocol, Tislelizumab was given prior to the CAR-pMACs on day 1. Receives: Drug: SY001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Maximum Tolerated Dose (MTD)
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Measured: up to 28 days after SY001 infusion.
Secondary outcomes (4)
Objective response rate (ORR)
Treatment response was assessed according to the criteria of RECIST 1.1, with PET-CT scans being the primary method used to evaluate tumor progression.
Measured: 3 months
Time to Peak (Tmax)
Changes in the CAR gene copy number after infusion of SY001; time to peak (Tmax) from 0 to 1 month.
Measured: 1 month
Area Under the Plasma Concentration Versus Time Curve (AUC)
Changes in the CAR gene copy number after infusion of SY001, area under the concentration-time curve (AUC) from 0 to 1 month
Measured: 1 month
Maximum Plasma Concentration of cytokines (Cmax)
Changes in cytokines in peripheral blood after infusion of SY001.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start12 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Related CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Origin Biotech (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Xudong Wang, Cell Origin Biotech (Hangzhou) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562647
- Sponsor's protocol ID
- KY2303
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06562647
- Acronym / sponsor ID
- KY2303
- Conditions
- Treatment Related Cancer, Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cell Origin Biotech (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Aug 2024 (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.
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
Detailed description
This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting | Experimental | Drug: SY001Patients with mesothelin-positive ovarian cancer were treated with an SY001 injection in combination with an anti-PD-1 antibody. Patient 001 received 1109 SY001 CAR-pMACs via intravenous injection. Following a two-month period in which the treatment's safety was confirmed, this patient underwent another two does of 1109 SY001 cells on both day 1 and day 3. Prior to the CAR-pMACs infusion on day 1, a PD1 antibody Tislelizumab Injection was administered. In the case of the patient 002, SY001 treatment was delivered intravenously on three occasions: day 1, day 3, and day 5. The same as the first patient's protocol, Tislelizumab was given prior to the CAR-pMACs on day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
- According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
- Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
- Estimated life expectancy >3 months;
- Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.
Key exclusion criteria (5 listed)
- Pregnant or lactating women;
- Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
- Patients who have a history of other mesothelin-targeting therapy;
- Patients who have a history of autoimmune disease;
- The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
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 |
|---|---|---|
| SY001Also: CAR-pMACPBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages | Drug | SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting |
Primary outcome
Identification of Maximum Tolerated Dose (MTD)
Time frame: up to 28 days after SY001 infusion.
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
4 secondary outcomes
Objective response rate (ORR)
Time frame: 3 months
Time to Peak (Tmax)
Time frame: 1 month
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: 1 month
Maximum Plasma Concentration of cytokines (Cmax)
Time frame: 1 month
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 13 Feb 2026.
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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.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SY001 in people with Treatment Related Cancer and Ovarian Cancer, run by Cell Origin Biotech (Hangzhou) Co., Ltd. at 2 sites 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 5 inclusion and 5 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Maximum Tolerated Dose (MTD) (time frame: up to 28 days after SY001 infusion.). 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 13 Feb 2026.