Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634357
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2020-11-04
Brief Title:
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma HCN-NOS or Hepatocellular Carcinoma
Sponsor:
Eureka Therapeutics Inc
Organization:
Eureka Therapeutics Inc
Study Overview
Official Title:
An Open-Label Dose Escalation Phase III Clinical Trial of ET140203 T Cells in Pediatric Subjects With RelapsedRefractory Hepatoblastoma HB Hepatocellular Neoplasm-Not Otherwise Specified HCN-NOS or Hepatocellular Carcinoma HCC
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARYA-2
Brief Summary:
Open-label dose escalation multi-center Phase III clinical trial to assess the safetytolerability and determine the recommended Phase II Dose RP2D of ET140203 T-cells in pediatric subjects who are AFP-positiveHLA-A2-positive and have relapsedrefractory HB HCN-NOS or HCC
Detailed Description:
The trial starts with a dose escalation phase A traditional dose escalation model 33 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None