AFPᶜ³³²T Cells for Advanced Liver Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byRichard S Finn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Adaptimmune

No Placebo Group

Trial Summary

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

I am between 18 and 75 years old and agree to participate in the study.

My organs are functioning well.

My liver cancer can't be treated with surgery or transplant. I may have treatment targeting specific areas after joining.

See 8 more

Exclusion Criteria

I had major surgery over 4 weeks ago and have recovered from it.

I have a severe autoimmune disease but not autoimmune hepatitis.

I used an experimental vaccine 2 months ago without improvement in my cancer.

See 27 more

Treatment Details

Interventions

AFPᶜ³³²T (CAR T-cell Therapy)

Trial OverviewThe study tests genetically modified T cells targeting the AFP protein on cancer cells. Patients' own T cells are taken and engineered in a lab to fight the cancer, then reinfused after chemotherapy. The trial aims to determine the safest dose level of these modified T cells and observe their effects on liver cancer or other AFP expressing tumors over time.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Autologous genetically modified AFPᶜ³³²T cellsExperimental Treatment1 Intervention