This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A\*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only). The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose. Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years.
Age range
18 Years – 75 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of Dose-limiting Toxicities (DLTs)
Timeframe: The DLT observation period was from the time of chemotherapy until 30 days following the infusion of AFPc332T cells for each participant in all groups.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first lymphodepleting chemotherapy through end of safety follow-up. Assessed at Days 9, 11, Weeks 2, 3, 4, 8, 12, 16, 24, then every 3 months until progression or withdrawal, up to approximately 4 years (data cut-off: 08 November 2022).
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: From first lymphodepleting chemotherapy through end of safety follow-up. Assessed at Days 9, 11, Weeks 2, 3, 4, 8, 12, 16, 24, then every 3 months until progression or withdrawal, up to approximately 4 years (data cut-off: 08 November 2022).