Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314828
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
A Tolerability Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL
Sponsor:
Guangdong Ruishun Biotech Co Ltd
Organization:
Guangdong Ruishun Biotech Co Ltd
Study Overview
Official Title:
A Phase 1 Open-label Single Arm Clinical Trial to Evaluate the Tolerability Safety and Efficacy of RJMty19 in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma NHL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This is a Phase 1 open-label single-arm study to evaluate tolerability safety and efficacy of RJMty19 in adult subjects with rr B-NHL
Detailed Description:
The study was based on an accelerated titration and 33 design with a dose-escalation phase and a dose-expansion phase and was designed to assess the safety maximum tolerated dose pharmacokinetic profile and initial efficacy of RJMty19 in subjects with rr B-NHL after second-line treatment or above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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