AFP?³³²T in Advanced HCC
Liver Cancer / Hepatoblastoma
18 - 75 Years, Male and Female
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.
- Subject is = 18 years and = 75 years of age and has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP Guidelines and applicable local regulations.
- Histologically confirmed HCC, not amenable to transplant, resection. Subjects may undergo loco-regional therapy after enrollment but not at time of lymphodepletion. Or Histologically confirmed diagnosis of another AFP expressing tumor (e.g. cholangiocarcinoma).
- Measurable disease according to RECIST 1.1 criteria prior to lymphodepletion.
- Progressive disease following or intolerant of or refuses standard of care systemic therapy prior to lymphodepletion.
- Positive for any A*02:01 P group allele.
- a) Group 1, 2, 3, (HCC) Subjects will be eligible for enrollment if they meet either one of these AFP expression criteria:
- AFP expression of =1+ in =20% of tumor cells by immunohistochemistry and their non-cancerous liver tissue has =5% cells stained for AFP at any intensity by immunohistochemistry.
- Serum AFP levels of =100ng/mL and their non-cancerous liver tissue has =5% cells stained for AFP at any intensity by immunohistochemistry.
- b) Group 4 (other AFP expressing tumor types) Subjects will be eligible for enrollment if they meet either one of these AFP expression criteria: o Serum AFP levels of =100ng/mL and their non-cancerous liver tissue (if applicable) has =5% cells stained for AFP at any intensity by immunohistochemistry.
- Life expectancy of > 4 months 8. Child-Pugh score = 6 9. Eastern Cooperative Oncology Group (ECOG) 0-1 10. Subject must have adequate organ function as defined in the protocol.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials