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A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE) - Trial NCT06340490

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.

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NCT06340490
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06340490
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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

Study Focus

RJMty19 (CD19-CAR-DNT cells)

Interventional

biological

Sponsor & Location

Guangdong Ruishun Biotech Co., Ltd

Beijing,Nanjing,Shanghai,Shanghai, China

Timeline & Enrollment

Phase 1

May 15, 2024

Dec 31, 2027

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 erythematosus
Systemic lupus erythematosus, unspecified
Lupus erythematosus
Systemic lupus erythematosus with organ or system involvement
Other forms of systemic lupus erythematosus

Data Source

ClinicalTrials.gov

NCT06340490

Non-Device Trial