Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Protocol # 17-033

Status

Recruiting

Description

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.

Condition

  • Hepatocellular Cancer
  • AFP Expressing Tumors

Interventions

  • Autologous genetically modified AFPᶜ³³²T cells

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Number of subjects with dose-limiting toxicity (DLT) and adverse events (AEs) and determination of optimally tolerated dose range, including serious adverse events (SAE).

Secondary Outcome:

  • Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR)
  • Interval between the date of first T cell infusion dose and first documented evidence of CR or PR
  • Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause
  • Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause
  • Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
  • Interval between the date of first T cell infusion and date of disease progression or death due to any cause

Enrollment

45

Study Start Date

May 8, 2017

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     75 Years
  • Healthy volunteers:     No

Sponsors

Adaptimmune

Source

Adaptimmune

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) or Other AFP Expressing Tumor Types

Clinicaltrials.gov Identifier

NCT03132792

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.