Plain-English translation of NCT05858684 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing a new treatment called GC012F, which uses specially engineered immune cells to help control systemic lupus erythematosus (SLE) — an autoimmune disease where the body mistakenly attacks its own tissues. The treatment works by removing the abnormal B cells that produce harmful antibodies, and researchers believe this could allow your immune system to rebuild and work normally again, potentially without needing long-term medications.
Many people with lupus don't respond well enough to current treatments, which means they continue to have active disease and symptoms despite taking multiple medications. This trial exists to see whether this medication can help patients who have 'tough-to-treat' lupus achieve better control or even remission.
You likely qualify if…
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You will have your immune cells collected through a procedure similar to blood donation (called apheresis), which takes several hours. The cells are then sent to a lab where they are modified and grown in larger numbers. After you receive chemotherapy to prepare your body, the modified cells are given back to you through an infusion. You will stay in the hospital for monitoring and attend regular follow-up visits to check how well the treatment is working and watch for side effects.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
China
Phase
Safety & dosing
Sponsor
RenJi Hospital
Collaborators
Gracell Biotechnologies (Shanghai) Co., Ltd.
Enrollment target
~18 participants
Started
May 2023
Primary completion
August 2028
Age range
18 Years – 70 Years
Last updated on clinicaltrials.gov in June 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Qiong Fu, PhD
RenJi Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.