Summary

for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Robin K Kelley

Description

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 liver tumor has the AFP protein 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.

Official Title

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)

Keywords

Hepatocellular Cancer Alpha-fetoprotein Cell Therapy T Cell Therapy SPEAR T Cell Immuno-oncology Metastatic Previously treated T Cell Receptor Liver Neoplasms Carcinoma, Hepatocellular Autologous genetically modified AFPᶜ³³²T cells

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  1. Histologically confirmed HCC, not amenable to transplant, resection or loco-regional therapy
  2. Measurable disease according to RECIST 1.1 criteria.
  3. Progressive disease following or intolerant of or refuses standard of care systemic therapy
  4. Positive for HLA-A02:01or HLA-A02:642 allele.

  5. Subject's tumor has AFP expression of ≥2+ in ≥40% tumor cells by immunohistochemistry and their non-cancerous liver tissue has ≤5% cells stained for AFP by immunohistochemistry.
  6. Life expectancy of > 4 months
  7. Child-Pugh score ≤ 6
  8. Eastern Cooperative Oncology Group (ECOG) 0-1
  9. Subject must have adequate organ function as defined in the protocol.

Key Exclusion Criteria:

  1. Positive for any of the HLA-A02 allele other than HLA-A02:01 or HLA-A02:642 or the following alleles: HLA-A02:02, HLA-C04:04 or HLA-B51:03.

  2. Prior liver transplant
  3. Clinically or radiographically detectable ascites (beyond trace/rim of ascites) or ascites requiring medication
  4. Clinically detectable hepatic encephalopathy or hepatic encephalopathy requiring medication
  5. Subject has known history of brain metastases.
  6. Other active malignancy besides HCC within 3 years.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adaptimmune
ID
NCT03132792
Phase
Phase 1
Lead Scientist
Robin K Kelley
Study Type
Interventional
Last Updated
May 8, 2018