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NCT06340490

A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)

A Phase I Clinical Trial of RJMty19 in Treatment of Subjects With Refractory Systemic Lupus Erythematosus
Guangdong Ruishun Biotech Co., Ltd·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Systemic Lupus Erythematosus
Drug/Device/Intervention
RJMty19 (CD19-CAR-DNT cells)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Guangdong Ruishun Biotech Co., Ltd
Location
Beijing,Nanjing,Shanghai,Shanghai, China
Timeline & enrollment
Phase
Phase 1
Start date
May 15, 2024
End date
Dec 31, 2027
Enrollment
24 participants
Primary outcome

Dose-Limiting Toxicity (DLT),Maximum Tolerated Dose (MTD),Incidence of abnormalities

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.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06340490
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06340490 through Pure Global AI's free database. This Phase 1 trial is sponsored by Guangdong Ruishun Biotech Co., Ltd and is currently Not yet recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.