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A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein (AFPᶜ³³²T) in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma (HCC) or Other AFP Expressing Tumor Types

Description

Brief Summary
This first time in human study is intended for men and women at least 18 years of age who have advanced liver cancer which has grown or returned after being treated. 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. This study is for subjects who have a blood test positive for appropriate HLA-A*02 and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein. 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.


Phase

N/A

Inclusion and Exclusion Criteria

  • Histologically confirmed HCC, not amenable to transplant, resection. Subjects may undergo loco-regional therapy after enrollment but not at time of lymphodepletion.
  • 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 HLA-A*02:01or HLA-A*02:642 allele.
  • 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 ≥400ng/mL and their non-cancerous liver tissue has ≤5% cells stained for AFP at any intensity by immunohistochemistry.
  • Life expectancy of > 4 months
  • Child-Pugh score ≤ 6
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Subject must have adequate organ function as defined in the protocol. Key

  • Positive for any of the HLA-A*02 allele other than HLA-A*02:01 or HLA-A*02:642 (except null alleles or HLA-A*02:03) or the following alleles: HLA-C*04:04 or HLA-B*51:03.
  • Prior liver transplant
  • Clinically or radiographically detectable ascites (beyond trace/rim of ascites) or ascites requiring medication
  • Clinically detectable hepatic encephalopathy or hepatic encephalopathy requiring medication
  • Subject has brain metastases.
  • Other active malignancy besides HCC within 3 years.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

Presentado por SC CTSI