Autologous CAR-T Cells Targeting B7-H3 in PDAC

Korábbi kezelés

• Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Egyéb

• Subject is not willing and able to comply with study procedures based on the judgment of the investigator.

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative.
• Age ≥ 18 years at the time of consent.
• Eastern Cooperative Oncology Group of 0-1 Performance Status)
• Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
• Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label.
• Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.