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

NCT06562647 | Recruiting

• 1 other identifier: KY2303
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.

Conditions

Treatment Related Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of Maximum Tolerated Dose (MTD)

  MTD will be determined based on DLTs observed during the first 28 days of study treatment.

  up to 28 days after SY001 infusion.

Secondary Outcomes (4)

• Objective response rate (ORR)

  3 months

• Time to Peak (Tmax)

  1 month

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  1 month

• Maximum Plasma Concentration of cytokines (Cmax)

  1 month

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: SY001

Interventions

SY001 DRUG

PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages

Also known as: CAR-pMAC

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cell Origin Biotech (Hangzhou) Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Linyi Cancer Hospital

Linyi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms, Second Primary; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: manager

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 20, 2024
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (2)