ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (ARYA-2)
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|ClinicalTrials.gov Identifier: NCT04634357|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : October 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatoblastoma Hepatocellular Carcinoma (HCC) Liver Neoplasms Metastatic Liver Cancer Liver Cancer HEMNOS||Drug: ET140203 T Cells||Phase 1 Phase 2|
The trial starts with a dose escalation phase. A traditional dose escalation model (3+3) design will be used to determine the recommended phase II dose (RP2D). Subjects will then be treated at the RP2D in the expansion phase of the trial.
Following treatment, tumor response assessments will be performed at Months 1, 3, 6, 9, 12, 18, and 24. At each tumor response assessment visit, imaging will be performed (triphasic CT Scan) and used for response evaluation. Serum AFP levels will also be measured at each tumor response assessment visit.
The active assessment phase of the study will continue for 2 years. Subjects will be followed for 15 years post-treatment for assessment of treatment safety and overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)|
|Estimated Study Start Date :||October 15, 2021|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2025|
Experimental: ET140203 T Cells
ET140203 T Cells
Drug: ET140203 T Cells
Biological/Vaccine: ET140203 autologous T-cell product
Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
- Incidence rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]Safety of ET140203 T cells as assessed by the number of adverse events (AEs) after infusion
- Severity rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]Safety of ET140203 T cells as assessed by the severity of adverse events (AEs) after infusion.
- Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells [ Time Frame: 28 days ]Tolerability of ET140203 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)
- The recommended phase 2 dose (RP2D) regimen of ET140203 T cell therapy primarily based on DLT [ Time Frame: Up to 2 years ]The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLTs.
- Assess the efficacy of ET140203 T cells in pediatric subjects with relapsed/refractory HB, HCN-NOS, or HCC [ Time Frame: Up to 2 years ]Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
- Determine the pharmacokinetics of ET140203 T cells after infusion. [ Time Frame: Up to 2 years ]Assess the expansion and persistence of ET140203 T cells circulating in blood over time.
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): NCT04634357
|Contact: Karen B Cravotto||510-722 email@example.com|
|Contact: Pei Wang, PhD||510-654 firstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber/Boston Children's Cancer and Blood Disorders Center|
|Boston, Massachusetts, United States, 02215|
|Contact: Allison O'Neill, MD 617-632-4202 Allison_ONeill@DFCI.HARVARD.EDU|
|Study Director:||Pei Wang, PhD||Eureka Therapeutics Inc.|