Recruiting
Phase 1

CAR-T Cells

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06158139

Conditions

Pancreas Cancer

Relapse

Resistant Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iC9-CAR.B7-H3 T cell infusion

Study Details

Brief 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.

Conditions

Pancreas Cancer

Relapse

Resistant Cancer

Study ID

NCT06158139

Start date

Jul 18, 2024

Status verified date

Jun, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CAR-T Cell Therapy

Single Arm Subjects with Refractory Pancreatic Ductal Adenocarcinoma (PDAC) cancer will receive iC9.CAR.B7-H3 T cells manufactured from their collected blood sample.

Interventions

iC9-CAR.B7-H3 T cell infusion

iC9-CAR.B7-H3 T cell product will be administered via intravenous injection over 5 - 10 minutes.

Primary outcome measure

  • Number of participants with adverse event [ Time Frame: Up to 4 weeks ]
  • Cytokine Release Syndrome [ Time Frame: Up to 4 weeks ]
  • Neurotoxicity [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Locations

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Ashwin Somasundaram, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • cellular therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-06-08.