Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus

Phase 1 Unknown 15 enrolled Zhejiang University Gracell Biotechnologies (Shanghai) Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

Timeline

Start: 2023-05-15
Primary completion: 2023-10-19
Completion: 2025-04-19

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC012F	Cell therapy	100000 cells/kg	Intravenous
Subject	GC012F	Cell therapy	200000 cells/kg	Intravenous
Subject	GC012F	Cell therapy	300000 cells/kg	Intravenous

Indications

No indication recorded.