Ovarian Cancer, Treatment Related Cancer
Conditions
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.
Interventions
DRUGSY001
PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages
Sponsors
Cell Origin Biotech (Hangzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Maximum Plasma Concentration of cytokines (Cmax) | 1 month | Changes in cytokines in peripheral blood after infusion of SY001. |
Countries
China
Outcome results
None listed