Not provided
Not provided
Not provided
Not provided
Reallocation of resources to new HCC study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).
The purpose of this study is to investigate a genetically modified autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140202 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET140202 T cells | Experimental | ET140202 Receptor (+) T Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET140202 autologous T cell product | Biological | Autologous T cells transduced with lentivirus encoding an ET140202 expression construct |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of adverse events (AEs) after infusion of ET140202 T cells | Safety and tolerability of ET140202 T cells as assessed by committee review of dose limiting toxicities (DLTs) and incidence and severity of adverse events (AEs) after infusion | 28 days |
| The recommended phase 2 dose (RP2D) regimen of ET140202 T-cell therapy | The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST). | As a measure of activity, overall response rate will be assessed by radiographic scans and assessed according to RECIST criteria. | up to 2 years |
| Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eureka Study Director | Eureka Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| UC Irvine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
As a measure of activity, CR rate will be assessed by radiographic scans and assessed according to RECIST criteria. |
| up to 2 years |
| Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST). | As a measure of activity, PR rate will be assessed by radiographic scans and assessed according to RECIST criteria. | up to 2 years |
| Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST). | As a measure of activity, PFS rate will be assessed by radiographic scans and assessed according to RECIST criteria. | up to 2 years |
| Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST). | As a measure of activity, OS rate will be assessed by radiographic scans and assessed according to RECIST criteria. | up to 2 years |
| Assess the expansion of ET140202 T cells in the blood shortly after infusion. | The maximum (peak) expansion of ET140202 T cells in the blood post infusion will be determined. | up to 2 years |
| Assess the persistence of ET140202 T cells circulating in blood over time. | The level of ET140202 T cells in blood will be determined to assess the persistence of ET140202 T cells during the treatment and follow-up phases of the study. | up to 2 years |
| Irvine |
| California |
| 92697 |
| United States |
| UC Davis | Sacramento | California | 95817 | United States |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |