AFPᶜ³³²T Cells for Advanced Liver Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. You must stop cytotoxic chemotherapy, immune therapy, and biological therapy 3 weeks before leukapheresis, and corticosteroids or other immunosuppressive therapy 2 weeks before. Specific cancer drugs like Sorafenib must be stopped 1 week before, and Cabozantinib 2 weeks before. Discuss any other medications with the study physician.
What data supports the effectiveness of the treatment AFPᶜ³³²T for advanced liver cancer?
Research shows that targeting alpha-fetoprotein (AFP), a protein often found in high levels in liver cancer, can trigger strong immune responses against cancer cells. Studies using similar approaches have demonstrated that engineered immune cells can effectively attack liver cancer cells by recognizing AFP as a target.12345
Is AFPᶜ³³²T treatment safe for humans?
The safety of AFPᶜ³³²T treatment specifically isn't detailed in the provided research, but similar treatments targeting alpha-fetoprotein (AFP) in liver cancer have shown promising safety profiles. For example, a study on T cell receptors targeting AFP in liver cancer found a candidate with an optimal safety profile, and another study on invariant natural killer T cells for liver cancer reported no severe adverse events.56789
What makes the AFPᶜ³³²T treatment unique for advanced liver cancer?
The AFPᶜ³³²T treatment is unique because it targets alpha-fetoprotein (AFP), a protein often elevated in liver cancer, to potentially enhance the immune system's ability to fight cancer cells. This approach is different from standard treatments as it focuses on using the body's immune response to specifically target cancer cells associated with AFP.510111213
What is the purpose of this trial?
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.
Research Team
Richard S Finn, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
This trial is for adults aged 18-75 with advanced liver cancer or other AFP expressing tumors, who have not responded to standard treatments or cannot tolerate them. Participants must have a life expectancy over 4 months, measurable disease progression, and specific levels of alpha-fetoprotein (AFP) in their blood and tumor cells. They should be relatively healthy otherwise, with adequate organ function and no severe heart or psychiatric conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
T Cell Manufacturing
The subject's T cells are collected and sent to a laboratory to be genetically modified
Chemotherapy
Participants receive 3 days of chemotherapy prior to T cell infusion
Treatment
Participants receive an intravenous infusion of genetically modified T cells and are hospitalized for at least 1 week
Initial Follow-up
Participants are seen frequently by the Study Physician for monitoring after T cell infusion
Extended Follow-up
Participants are seen every three months for continued monitoring
Long-term Follow-up
Participants are monitored for safety and effectiveness every 6 months for the first 5 years, then annually for the next 10 years
Treatment Details
Interventions
- AFPᶜ³³²T
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adaptimmune
Lead Sponsor