Status:
TERMINATED
Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma
Lead Sponsor:
Aeon Therapeutics (Shanghai) Co., Ltd.
Collaborating Sponsors:
Renmin Hospital of Wuhan University
Eureka Therapeutics Inc.
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC
Detailed Description
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 anti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- AFP-expressing HCC and serum AFP \>100 ng/mL.
- Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 20 mm.
- Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele
- Child-Pugh score of A or B
- Life expectancy \> 4 months
- Age at time of enrollment is ≥18 years of age.
- KPS ≥70%
- Adequate organ function as defined below:
- A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
- Patients must have a serum direct bilirubin ≤2 x ULN, ALT and AST ≤5 times the institutional upper limits of normal.
- Ejection Fraction measured by echocardiogram or MUGA \>45% (evaluation done within 6 weeks of screening does not need to be repeated)
- DLCO or FEV1 \>45% predicted
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (10\^9/L)
- Platelet count ≥ 50,000/mm3 (10\^9/L)
- Negative serum pregnancy test for women with childbearing potential
- Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
- Exclusion criteria:
- Patients with decompensated cirrhosis: Child-Pugh Score C
- Patients with an organ transplantation history
- Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
- Patients with dependence on corticosteroids
- Patients with active autoimmune diseases requiring systemic immunosuppressive therapy
- Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery
- Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
- Patients undergoing current treatment known to interfere with lymphodepleting chemotherapy (cyclophosphamide, etc.).
- Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.
- Patients with other uncontrolled diseases, such as active infections:
- Acute or chronic active hepatitis B or hepatitis C.
- HIV-infection
- Women who are pregnant
Exclusion
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03349255
Start Date
October 6 2017
End Date
January 10 2019
Last Update
July 1 2019
Active Locations (1)
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1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060