Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06158139

Autologous CAR-T Cells Targeting B7-H3 in PDAC

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-03-19

27

Participants Needed

1

Research Sites

297 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

M

M.D. Anderson Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Autologous CAR-T Cells Targeting B7-H3 in PDAC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent and HIPAA authorization
  • Be 18 years or older at the time of consent
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have histological or cytological confirmation of pancreatic ductal adenocarcinoma
  • Female participants of childbearing potential must agree to abstain from heterosexual activity or use two effective contraception methods from consent until 6 months after treatment ends
  • Male participants with female partners must have had a prior vasectomy or agree to use adequate contraception from first dose through 3 months after cell infusion therapy
Not Eligible

You will not qualify if you...

  • Have a prior or current malignancy that could interfere with safety or efficacy assessments
  • Be unwilling or unable to comply with study procedures based on investigator judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

C

Catherine Cheng

CONTACT

C

Caroline Babinec

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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