SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
- Registration Number
- NCT06562647
- Lead Sponsor
- Cell Origin Biotech (Hangzhou) Co., Ltd.
- 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 evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 2
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting SY001 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.
- Primary Outcome Measures
Name Time Method Identification of Maximum Tolerated Dose (MTD) up to 28 days after SY001 infusion. MTD will be determined based on DLTs observed during the first 28 days of study treatment.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) 3 months 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.
Maximum Plasma Concentration of cytokines (Cmax) 1 month Changes in cytokines in peripheral blood after infusion of SY001.
Time to Peak (Tmax) 1 month Changes in the CAR gene copy number after infusion of SY001; time to peak (Tmax) from 0 to 1 month.
Area Under the Plasma Concentration Versus Time Curve (AUC) 1 month Changes in the CAR gene copy number after infusion of SY001, area under the concentration-time curve (AUC) from 0 to 1 month
Trial Locations
- Locations (1)
Linyi Cancer Hospital
🇨🇳Linyi, China