Status:
RECRUITING
Autologous CAR-T Cells Targeting B7-H3 in PDAC
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Pancreas Cancer
Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 inducib...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06158139
Start Date
July 18 2024
End Date
June 1 2028
Last Update
March 18 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599