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)

Trial ID: NCT06158139

Interventional - Phase 1 - Recruiting

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.

Conditions

• Pancreas Cancer
• Relapse
• Resistant Cancer

Interventions

• iC9-CAR.B7-H3 T cell infusion

Eligibility

Inclusion criteria

• 1. 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.
• 2. Age ≥ 18 years at the time of consent.
• 3. Eastern Cooperative Oncology Group of 0-1 Performance Status)
• 4. Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
• 5. 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.
• 6. 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 criteria

• 1. 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.
• 2. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.

Sponsor

UNC Lineberger Comprehensive Cancer Center, M.D. Anderson Cancer Center

Source: ClinicalTrials.gov

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