a study on Hepatocellular Cancer
This study will investigate the safety and tolerability of AFPᶜ³³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker, whose liver tumor has the AFP protein and whose noncancerous liver tissue has very little AFP protein. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors.
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)
This is a first time in human, dose escalation study of genetically engineered AFPᶜ³³²T cells in HLA-A *02:01 positive subjects with advanced hepatocellular cancer (HCC).
Subjects who are eligible based on HLA type and have AFP positive, histologically confirmed measurable HCC that is not amenable to transplant, resection or locoregional therapy will be screened for general health, performance status and disease stage. Subjects must also have a relative absence of AFP expression in their noncancerous liver tissue.
Following screening, subjects meeting all eligibility criteria will undergo leukapheresis to obtain cells for the manufacture of autologous AFP TCR bearing T cells. All eligibility criteria will be reconfirmed and baseline tumor measurements will be obtained prior to lymphodepleting therapy.
Once manufacturing of AFPᶜ³³²T cells is complete, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide alone (Group 1a) or cyclophosphamide plus fludarabine (Group 1B, 2 and 3), followed by infusion of transduced cells on Day 1. AFPᶜ³³²T cell dose escalation starts at 1 x 10⁸ cells with target cell dose of 5 x 10⁹ cells.
Hepatocellular Cancer Alpha-fetoprotein Cell Therapy T Cell Therapy SPEAR T Cell Immuno-oncology Metastatic Previously treated T Cell Receptor
Open to people ages 18–75
Subject must have adequate organ function as indicated by the following laboratory values below:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03132792.
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