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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Guangdong Ruishun Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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) and/or 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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	RJMty19 (CD19-CAR-DNT cells)	Lentiviral vector-transducted double negative T cells (DNT) to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

4 sites across 1 country: China