NCT06297408

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus Single Arm Phase I and Phase II Randomized Controlled Open, Multicenter Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Detailed description

For phase I to evaluate the safety and tolerability of Relma-cel in moderate to severe active systemic lupus erythematosus (SLE) and determine the Phase II Recommended Dose (RP2D). For phase II to evaluation of the efficacy of Relma-cel (treatment group) in moderate to severe active SLE using the Low Disease Activity State of Lupus (LLDAS) under Phase II Recommended Dose (RP2D) compared to conventional therapy combined with or without biologics (control group).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Relma-cel	CD19-targeted Chimeric AntigenReceptor (CAR) T Cells

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2024-03-07
• Last updated: 2024-03-07