Autologous CAR-T Cells Targeting B7-H3 in PDAC
A Phase I Study of Autologous CAR-T Cells Targeting the B7-H3 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Refractory Pancreatic Ductal Adenocarcinoma (PDAC)
UNC Lineberger Comprehensive Cancer Center
27 participants
Jul 18, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria2
- 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.
- Subject is not willing and able to comply with study procedures based on the judgment of the investigator.
Interventions
iC9-CAR.B7-H3 T cell product will be administered via intravenous injection over 5 - 10 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06158139