Description:
This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to
assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18
years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2)
different anti-HCC systemic agents.
Title
- Brief Title: ECT204 T-Cell Therapy in Adults With Advanced HCC
- Official Title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)
Clinical Trial IDs
- ORG STUDY ID:
ETUS20GPC3AR124
- NCT ID:
NCT04864054
Conditions
- Hepatocellular Carcinoma
- Liver Cancer, Adult
- Liver Neoplasm
- Metastatic Liver Cancer
Interventions
Drug | Synonyms | Arms |
---|
ECT204 T cells | | ECT204 |
Purpose
This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to
assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18
years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2)
different anti-HCC systemic agents.
Detailed Description
The purpose of this study is to investigate an autologous T-cell therapy for advanced
hepatocellular carcinoma (HCC). ECT204 T cells are autologous T cells genetically modified to
carry a construct capable of mediating cell killing by targeting tumor specific antigens.
Trial Arms
Name | Type | Description | Interventions |
---|
ECT204 | Experimental | A minimum of twelve (12) subjects will be treated to determine the RP2D. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
- GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC).
- Must have failed or not tolerated at least two (2) different anti-HCC systemic agents.
- Life expectancy of at least 4 months per Principal Investigator's opinion.
- Karnofsky Performance Scale ≥ 70.
- Measurable disease by RECIST v.1.1. Previously treated lesions are allowed as long as
there is a new confirmed measurable component.
- Child-Pugh score A6 or better.
- Adequate organ function.
Exclusion Criteria:
- Clinically significant pre-existing illness (e.g., heart failure)
- Uncontrolled systemic bacterial, fungal, or viral infection
- Active malignancy other than HCC, with the exception of cholangiocarcinoma (CCA)
without any organ involvement and with an expected survival greater than or equal to 3
years without any treatment (exception: hormone/androgen- deprivation therapy)
- Active autoimmune disease requiring therapy
- Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
- History of organ transplant
- Advanced HCC involving greater than half (50%) of the liver
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rates of adverse events (AEs) after infusion of ECT204 T cells |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion. |
Secondary Outcome Measures
Measure: | Assess the efficacy of ECT204 T cells in subjects with advanced HCC by radiographic scans assessed according to RECIST and iRECIST criteria. |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria. |
Measure: | Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion. |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Determine the degree of expansion of ECT204 T cells after infusion. |
Measure: | Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion. |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Determine the expansion kinetics of ECT204 T cells after infusion. |
Measure: | Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28). |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Assess the expansion and persistence of ECT204 T cells after infusion. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Eureka Therapeutics Inc. |
Trial Keywords
- Hepatocellular Carcinoma HCC
- Advanced HCC
- Late-Stage HCC
- Liver Cancer
- Liver Neoplasm
- Metastatic Liver Cancer
- Metastatic HCC
- T-cell therapy
- Immunotherapy
Last Updated
July 27, 2021