SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors

NCT ID: NCT06562647

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2025-04-30

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.

Conditions

Treatment Related Cancer; Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting

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.

Group Type: EXPERIMENTAL

SY001

Intervention Type: DRUG

PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages

Interventions

SY001

PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages

Intervention Type: DRUG

Other Intervention Names

CAR-pMAC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cell Origin Biotech (Hangzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Xudong Wang

manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Linyi Cancer Hospital

Linyi, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiumin Li

Role: primary

Lyzlyylxm@163.com

+86 18868115772

Other Identifiers

KY2303

Identifier Type: -

Identifier Source: org_study_id