Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03888859 | ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma | EARLY_PHASE1 | COMPLETED | 12 | — | — | Dec 6, 2017 | Dec 8, 2020 | Mar 29, 2021 | 1 | China |
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET1402L1-ARTEMIS™2 T-cells, which is irreversible, or life threatening or CTCAE Grade 3-5. Assessed at all visits.
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.
| Arm | Type | Description |
|---|---|---|
| Intravenous (i.v.) arm | EXPERIMENTAL | autologous ET1402L1-ARTEMIS™2 T cells administered by intravenous (IV) infusion |
| Intra-hepatic artery (i.a.) arm | EXPERIMENTAL | autologous ET1402L1-ARTEMIS™2 T cells administered by intra-hepatic artery (IA) infusion |
| Intratumoral Injections (i.t.) arm | EXPERIMENTAL | autologous ET1402L1-ARTEMIS™2 T cells administered by intratumoral injections (i.t.) infusion |
| Name | Type | Description |
|---|---|---|
| ET1402L1-ARTEMIS™ T cells -IV | BIOLOGICAL | Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm |
| ET1402L1-ARTEMIS™ T cells -intra-hepatic artery | BIOLOGICAL | Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm |
| ET1402L1-ARTEMIS™ T cells -Intratumoral Injections | BIOLOGICAL | Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm |
Inclusion Criteria: * AFP-expressing HCC and serum AFP \>100 ng/mL. * Abandon or failure in first or second line treatment * Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele * Child-Pugh score of A or B, Barcelona Clinic Liver Cancer stage of C or D * Life expec...