Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 1:11 AM
Study NCT ID:
NCT06314828
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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 r/r B-NHL.
Detailed Description:
The study was based on an accelerated titration and "3+3" 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 r/r B-NHL after second-line treatment or above.
Study Oversight
Has Oversight DMC:
False
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?: