Official Title: A Phase I/II Open-Label Study to Evaluate the Safety, Cellular Kinetics and Efficacy of AZD5851, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against GPC3 in Adult Participants With Advanced/Recurrent HEpatocellular CarciNomA: ATHENA
A Study On:
Liver
Study Description
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
Eligibility
-Participants must be 18 years or older or the legal age of consent in the jurisdiction in which the study is taking place, at the time of singing the informed consent form.
-Confirmed advanced/recurrent or metastatic and/or unresectable hepatocellular carcinoma (HCC) based on histopathological findings (no mixed HCC-cholangiocarcinoma permitted)
-Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
-Prior treatment with (a) any CAR-T therapy directed at any target (b) any therapy that is targeted to GPC3
-Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study, or within a minimum of 4 weeks after study treatment administration (Note: participants with planned surgical procedures to be conducted under local anesthesia may participate)
-Prior solid organ transplant including liver transplantation or presence on waiting list
Interested in Participating in this Trial?
Thank you for your interest with our team.
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Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
Please read the information below and ask questions about anything that you do not understand. A
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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
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Data Retention - In accordance with UC Office of the President policy, information will be retained for
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