NCT06158139

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 1, single-center, open-label study to determine the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells targeting the B7-H3 antigen and containing the inducible caspase 9 safety switch (iC9-CAR.B7-H3 T cells) administered to adult subjects with refractory pancreatic ductal adenocarcinoma. The safety of iC9-CAR.B7-H3 T cells will be investigated using a modified 3+3 design with a starting dose of 1 × 106 transduced cells/kg. The data from the dose escalation will be used to determine a recommended phase 2 dose, which will be decided based on the maximum tolerated dose and additional factors such as the ability to manufacture sufficient cells for infusion. The body has different ways of fighting cancer and other diseases; however, no single way seems perfect. The experimental treatment in this study combines two different ways the body fights cancer, and they are antibodies and T cells. Antibodies are proteins that protect the body from foreign invaders like bacteria. Antibodies work by attaching to these bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancer. They both have shown promise, but neither alone has been able to cure most patients. The treatment that is being studied in this study is called autologous T lymphocyte chimeric antigen receptor cells targeted against the B7-H3 antigen and containing inducible caspase 9 safety switch (iC9). The short name for this treatment is iC9.CAR.B7-H3 T cells. For the rest of this consent, we will refer to the iC9.CAR.B7-H3 T cells as the modified CAR-T cells for ease of reading this consent.

Conditions

• Pancreas Cancer
• Relapse
• Resistant Cancer

Interventions

Type	Name	Description
BIOLOGICAL	iC9-CAR.B7-H3 T cell infusion	iC9-CAR.B7-H3 T cell product will be administered via intravenous injection over 5 - 10 minutes.

Timeline

• Start date: 2024-07-18
• Primary completion: 2028-04-01
• Completion: 2030-04-01
• First posted: 2023-12-06
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study