Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340490
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
A Study of RJMty19 in Refractory Systemic Lupus Erythematosus SLE
Sponsor:
Guangdong Ruishun Biotech Co Ltd
Organization:
Guangdong Ruishun Biotech Co Ltd
Study Overview
Official Title:
A Phase I Clinical Trial of RJMty19 in Treatment of Subjects With Refractory Systemic Lupus Erythematosus
Status:
NOT_YET_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:
None
Brief Summary:
This study is an open-label single-arm dose escalation and dose expansion study to evaluate the safety maximum tolerated dose pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells RJMty19 after infusion and preliminary efficacy in systemic lupus erythematosus SLE subjects
Detailed Description:
The dose escalation part Part A plans to enroll 9-18 subjects with refractory SLE receiving RJMty19 infusion to determine the maximum tolerated dose MTD andor RP2D of RJMty19 The dose expansion part Part B plans to enroll 3-6 subjects The Safety Review Committee SRC monitors the safety information of the subjects and evaluates the safety data of each dose group To ensure the quality of the experiment the sponsor and inverstigators will jointly discuss and formulate the clinical research plan before the formal experiment begins
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