Status:
RECRUITING
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Lead Sponsor:
Cell Origin Biotech (Hangzhou) Co., Ltd.
Conditions:
Treatment Related Cancer
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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 evalua...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06562647
Start Date
April 12 2023
End Date
April 1 2025
Last Update
August 20 2024
Active Locations (1)
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1
Linyi Cancer Hospital
Linyi, China