Who is eligible for clinical trial NCT06158139?

Participants must meet protocol criteria for Pancreas Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06158139 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-05

Autologous CAR-T Cells Targeting B7-H3 in PDAC (NCT06158139)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: UNC Lineberger Comprehensive Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (3 items).

Location: University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗