Trial Profile

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

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 27 Dec 2023

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At a glance

21 Dec 2023 According to a Gracell Biotechnology media release, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus.
13 Nov 2023 According to a Gracell Biotechnology media release, patient enrollment and dosing progressing and is on track to release initial data in the first half of 2024.
14 Aug 2023 According to a Gracell Biotechnology Media release, the company is on track to file the US IND in 2023 to conduct a Phase 1 trial for GC012F in rSLE.Patient enrollment and dosing isunderway.

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