AFPᶜ³³²T in Advanced HCC
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|ClinicalTrials.gov Identifier: NCT03132792|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 21, 2020
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 or disease||Intervention/treatment||Phase|
|Hepatocellular Cancer AFP Expressing Tumors||Genetic: Autologous genetically modified AFPᶜ³³²T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2026|
|Experimental: Autologous genetically modified AFPᶜ³³²T cells||
Genetic: Autologous genetically modified AFPᶜ³³²T cells
Infusion of autologous genetically modified AFPᶜ³³²T cells
- Number of subjects with dose-limiting toxicity (DLT) and adverse events (AEs) and determination of optimally tolerated dose range, including serious adverse events (SAE). [ Time Frame: 2 years ]Determine if treatment with autologous genetically modified T cells, (AFPᶜ³³²T) is safe and tolerable through assessment of DLTs, AEs, including SAEs; laboratory assessments including chemistry, hematology, coagulation, cardiac assessments including ECG, and cardiac Troponin
- Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
- Interval between the date of first T cell infusion dose and first documented evidence of CR or PR [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of time to first response
- Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of duration of response
- Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of duration of stable disease
- Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of progression-free survival
- Interval between the date of first T cell infusion and date of disease progression or death due to any cause [ Time Frame: 2 years ]Evaluation of the efficacy of the treatment by assessment of overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132792
|Principal Investigator:||Richard S Finn, MD||University of California, Los Angeles|