A Phase 1 interventional study of autologous ET1402L1-CART cells in Hepatocellular Carcinoma, Liver Cancer and Liver Neoplasms, sponsored by Aeon Therapeutics (Shanghai) Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-01.
Sponsored by Aeon Therapeutics (Shanghai) Co., Ltd. · Phase 1, Interventional, and Treatment
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC
The molecular target for ET1402L1-CART is alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). ET1402L1-CART is a second generation (CD28/CD3ζ) chimeric antigen receptor (CAR) engineered with a human single-chain variable antibody fragments (scFv) against the anti-HLA-A02/AFP complex. This clinical study evaluates the safety and pharmacokinetics of ET1402L1-CART-cells in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.
Patients with lesion(s) localized in liver will be enrolled in the IA arm, with the ET1402L1-CART-cells administered via intrahepatic artery catheter. Patients with extrahepatic metastasis will be enrolled in the IV arm, with the ET1402L1-CART-cells administered through intravenous infusion.
Adequate organ function as defined below:
Exclusion criteria:
Patients with other uncontrolled diseases, such as active infections:
autologous ET1402L1-CART cells administered by intravenous (IV) infusion
Biological: autologous ET1402L1-CART cells
autologous ET1402L1-CART cells administered by intra-hepatic artery (IA) infusion
Biological: autologous ET1402L1-CART cells
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1)-CAR expression construct
Number of patients with dose-limiting toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET1402L1-CART-cells, which is irreversible, or life threatening or CTCAE Grade 3-5. Assessed at all visits.
Time frame: 28 days up to 2 years
Toxicity profile of ET1402L1-CART-cell treatment
Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET1402L1-CART T cells related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Time frame: 28 days up to 2 years
Rate of disease response by RECIST in the liver
Response rates will be estimated as the percent of patients with objective response (OR), complete remission (CR), partial response (PR), stable disease (SD), no response (NR), overall survival (OS).
Time frame: 2 years
Rate of disease response by RECIST at non-liver sites
Response rates will be estimated as the percent of patients with objective response (OR), complete remission (CR), partial response (PR), stable disease (SD), no response (NR), overall survival (OS).
Time frame: 2 years
Anti-tumor responses
Progression free survival (PFS) and Median survival (MS) at 4 months, 1 year, 2 years
Time frame: 4 months, 1 year, 2 years
AFP serum levels
Percent change compared to the baseline
Time frame: 2 years
CART cell engraftment
Number and % of ET1402L1-CART cells in peripheral blood will be presented as Time to peak, Time to baseline level and the overall exposure will be presented as area under curve (AUC).
Time frame: 2 years
AFP expression in tumors
Percent of AFP-positive cells in randomly selected fields in tumor biopsies
Time frame: 4-8 weeks
Tmax of serum cytokine levels
Increases or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immuoassays will be presented as time to peak level.
Time frame: 24 weeks
Time to baseline for serum cytokine levels
Increases or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immuoassays will be presented as Time to baseline.
Time frame: 24 weeks
AUC of serum cytokine levels
Increases or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immuoassays will be presented as area under curve (AUC).
Time frame: 24 weeks
Plan to share: Undecided
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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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