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A clinical research of CAR-T cells targeting mesothelin and B7-H3 in the treatment of advanced solid tumors

A clinical research of CAR-T cells targeting mesothelin and B7-H3 in the treatment of advanced solid tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049630
Enrollment
Unknown
Registered
2021-08-07
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid tumors

Interventions

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years. 2. Pathologically diagnosed pancreatic cancer or triple-negative breast cancer that has failed after first-line, second-line and/or more than second-line treatments. 3. The histopathological result of the patient's tumor is antigen expression, such as mesothelin >= 15%, or B7-H3 >= 15%. 4. The patient must have measurable or evaluable lesions on ultrasound or CT/MRI scans (in the case of lymph nodes, short diameter >=15mm). 5. ECOG score of 0 to 2, the minimum expected survival of 12 weeks. 6. Have sufficient venous access for apheresis or venous blood collection. 7. Females of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting dosing, a pregnancy test was negative, or no pregnancy risk was demonstrated. 8. Male patients should use barrier contraception (ie condoms) from screening to 3 months after discontinuation of study treatment. 9. The patient himself participated voluntarily and signed the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. HIV positive, HBV DNA>500 and HCV positive, syphilis positive. 2. Intracranial hypertension or unconsciousness. 3. Untreated central nervous system metastases; patients with central nervous system tumors. 4. Rapidly progressive disease with a life expectancy of 250 msec; (2) Left ventricular ejection fraction (LVEF) 100 U/L, aspartate aminotransferase (AST) > 100 U/L; (5) Creatinine>200µmol/L; (6) Total bilirubin>30µmol/L. 9. The patient needs long-term antiplatelet therapy (aspirin, dose > 300mg/day; clopidogrel, dose > 75mg/day). 10. Within two weeks before the start of the study, radiotherapy and chemotherapy for the study disease or targeted antitumor drugs have been used. 11. Major surgery or significant trauma within two weeks prior to the start of the study (blood collection), or expected to require major surgery during the study. 12. The investigator with a history of psychiatric evaluation believes that the patient is unable or unwilling to comply with the requirements of the research protocol. 13. The investigator assesses that the patient is unable or unwilling to comply with the requirements of the research protocol.

Design outcomes

Primary

MeasureTime frame
CAR-T cells;

Countries

China

Contacts

Public ContactWang Bo

The Seventh Affiliated Hospital of Sun Yat-sen University

wangb68377@sina.com+86 15626154498

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026