ECT204 T-Cell Therapy in Adults With Advanced HCC (ARYA3)
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|ClinicalTrials.gov Identifier: NCT04864054|
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Liver Cancer, Adult Liver Neoplasm Metastatic Liver Cancer||Biological: ECT204 T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Sequential assignment|
|Masking:||None (Open Label)|
|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)|
|Estimated Study Start Date :||August 15, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||July 31, 2024|
A minimum of twelve (12) subjects will be treated to determine the RP2D.
Biological: ECT204 T cells
ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
- Incidence rates of adverse events (AEs) after infusion of ECT204 T cells [ Time Frame: 28 days ]Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion.
- Severity rates of adverse events (AEs) after infusion of ECT204 T cells [ Time Frame: 28 days ]Safety of ECT204 T cells as assessed by the severity of adverse events (AEs) after infusion.
- Incidence rates of dose limiting toxicities (DLTs) after infusion of ECT204 T cells [ Time Frame: 28 days ]Tolerability of ECT204 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)
- The recommended phase 2 dose (RP2D) of ECT204 T cells [ Time Frame: Up to 2 years ]
The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen
based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD).
- 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 ]Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria.
- Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion. [ Time Frame: Up to 2 years ]Determine the degree of expansion of ECT204 T cells after infusion.
- Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion. [ Time Frame: Up to 2 years ]Determine the expansion kinetics of ECT204 T cells after infusion.
- Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28). [ Time Frame: 28 days ]Assess the expansion and persistence of ECT204 T cells after infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864054
|Contact: Karen B Cravottofirstname.lastname@example.org|
|Contact: Pei Wang, PhDemail@example.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Claudia Aceves 626-218-5114 CAceves@coh.org|
|Principal Investigator: Daneng Li, MD|
|United States, Kansas|
|Kansas University Cancer Center||Not yet recruiting|
|Westwood, Kansas, United States, 66205|
|Contact: Jeffrey Roesgen 913-945-8679 firstname.lastname@example.org|
|Principal Investigator: Raed Al-Rajabi, MD|
|Study Director:||Pei Wang, PhD||Eureka Therapeutics Inc.|