RecruitingPhase 1NCT06158139

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)


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

27 participants

Start Date

Jul 18, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called CAR-T cells, engineered to target a protein called B7-H3 found on pancreatic cancer cells. These specially modified immune cells are taken from the patient, altered in a lab to recognize and attack the tumor, and then infused back into the patient. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with pancreatic ductal adenocarcinoma (a type of pancreatic cancer) confirmed by tissue biopsy or pathology - Your overall health meets the required performance status - You are willing and able to provide informed consent - If you are of childbearing potential, you agree to use contraception **You may NOT be eligible if...** - You do not have confirmed pancreatic ductal adenocarcinoma - Your overall health or organ function does not meet the required thresholds - You are unwilling to comply with contraception requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALiC9-CAR.B7-H3 T cell infusion

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


Locations(1)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT06158139


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