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Trial Title:
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
NCT ID:
NCT06562647
Condition:
Treatment Related Cancer
Ovarian Cancer
Conditions: Official terms:
Neoplasms, Second Primary
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SY001
Description:
PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages
Arm group label:
SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting
Other name:
CAR-pMAC
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. 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);
3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ
functions;
4. Estimated life expectancy >3 months;
5. 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.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Any uncontrollable active infection, including but not limited to active
tuberculosis, HBV infection;
3. Patients who have a history of other mesothelin-targeting therapy;
4. Patients who have a history of autoimmune disease;
5. The investigator assessed that the patient was unable or unwilling to comply with
the requirements of the study protocol.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiumin Li
Phone:
+86 18868115772
Email:
Lyzlyylxm@163.com
Start date:
April 12, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Cell Origin Biotech (Hangzhou) Co., Ltd.
Agency class:
Industry
Source:
Cell Origin Biotech (Hangzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06562647
