Autologous CAR-T Cells Targeting B7-H3 in PDAC

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called autologous CAR-T cells that target a specific protein called B7-H3 in patients with pancreatic cancer (specifically, pancreatic ductal adenocarcinoma) that has returned after standard treatments. The goal is to see if this experimental therapy is safe and well-tolerated in adults aged 18 and older who are dealing with this challenging cancer. It's important to note that this treatment has not yet been approved by the FDA, meaning it's still being tested in research.

To participate in this trial, individuals must provide informed consent, meaning they understand the study and agree to take part. They should have confirmed pancreatic cancer and be in good overall health, as defined by a performance status score. Women of childbearing age must agree to use effective birth control during the study, while men must either be previously vasectomized or use contraception during the treatment period. Participants can expect close monitoring throughout the trial to ensure their safety and to gather important information about how well the treatment works. If you're interested in participating or want more information, please reach out to the study team.

Gender

ALL

Eligibility criteria

• 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.