Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343311
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-14
Brief Title:
T-Cell Therapy EB103 in Adults With RelapsedRefractory B-Cell Non-Hodgkins Lymphoma NHL
Sponsor:
Estrella Biopharma Inc
Organization:
Estrella Immunopharma Inc
Study Overview
Official Title:
An Open-Label Dose Escalation Multi-Center Phase III Clinical Trial of EB103 T-Cell Therapy in Adults With RelapsedRefractory RR B-Cell Non-Hodgkins Lymphoma NHL
Status:
RECRUITING
Status Verified Date:
2024-07
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:
STARLIGHT-1
Brief Summary:
This is an open-label dose escalation multi-center Phase III clinical trial to assess the safety of an autologous T-cell therapy EB103 and to determine the Recommended Phase II Dose RP2D in adult subjects 18 years of age who have relapsedrefractory RR B-cell NHL The study will include a dose escalation phase followed by an expansion phase
Detailed Description:
This is an open-label dose escalation multi-center Phase III clinical trial to assess the safety of EB103 and determine the RP2D in adult subjects 18 years of age who have RR B-cell NHL
The study will include a dose escalation phase followed by an expansion phase A traditional dose escalation model 33 design will be used to determine the RP2D and once determined the expansion phase will commence Additional subjects will be enrolled in the expansion phase to further confirm the safety profile of EB103 at the RP2D and evaluate the preliminary efficacy of EB103
The study will include a dose escalation phase followed by an expansion phase A traditional dose escalation model 33 design will be used to determine the RP2D and once determined the expansion phase will commence Additional subjects will be enrolled in the expansion phase to further confirm the safety profile of EB103 at the RP2D and evaluate the preliminary efficacy of EB103
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