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CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

Clinical Trial Summary

This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Clinical Trial Description

This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics(PK) and pharmacodynamics(PD) of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. There will be 4 dose level (15x106 CAR+ T cells as the back up dose ,25x106 CAR+ T cells as the starting dose 、50x106 CAR+ T cells and 100x106(or 150 x106CAR+ T cells）Dose escalation, to evaluate the safety、 tolerability of Relma-cel in adult subjects of SLE and determine RP2D . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05765006
Study type Interventional
Source Shanghai Ming Ju Biotechnology Co., Ltd.
Contact medical JW
Phone +86 21 50464201
Email Relma-celMedical@jwtherapeutics.com
Status Recruiting
Phase Phase 1
Start date February 24, 2023
Completion date December 30, 2025
View Details
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