Actively Recruiting
Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus Patients
Led by RenJi Hospital · Updated on 2026-06-01
18
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of GC012F injection, which contains CD19-BCMA CAR-T cells, in patients with refractory systemic lupus erythematosus (SLE), an autoimmune disease involving multiple organs and caused by abnormal immune activity. This early exploratory phase study aims to find the maximum dose of this treatment that patients can tolerate, focusing on rebuilding normal immune function and potentially achieving drug-free remission. Participants will receive the GC012F injection by intravenous infusion on Day 0 during a dose escalation phase that tests increasing doses from 0.5 x 10^5/kg up to 3 x 10^5/kg. This single-arm, open-label trial does not randomize participants and monitors safety and response carefully. The study evaluates the treatment's effects on immune cells and gene copies in blood and bone marrow over several weeks after infusion. During the study, participants will undergo regular evaluations including safety monitoring for adverse events within 12 weeks of treatment, assessments of disease activity and response using standardized criteria at multiple time points up to 24 weeks, and blood and bone marrow tests to measure CAR-T cell presence. Follow-up visits are required to track immune system rebuilding and overall health for up to 24 weeks post-infusion, with total participation spanning several months.
CONDITIONS
Brief Title
Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Total score of 10 or higher on the EULAR/ACR 2019 SLE classification criteria
- Not achieving low disease activity after at least two immunosuppressants or one approved biological agent for over 6 months
- SELENA-SLEDAI score of 8 or more
- Presence of CD19 positive B cells
- Hemoglobin level of at least 85 g/L
- White blood cell count of at least 2.5 x 10^9/L
- Neutrophil count of at least 1 x 10^9/L
- Blood platelet count of at least 50 x 10^9/L
- Liver enzymes (AST/ALT) less than twice the upper normal limit
- Creatinine clearance of 30 mL/min or more
- Blood bilirubin level of 2.0 mg/dl or less
- Heart ejection fraction of 50% or higher by echocardiography
- Adequate venous access for apheresis and no contraindications to leukapheresis
- Negative pregnancy test for women of childbearing age at screening and baseline
- Agreement to use effective contraception during the study and for 1 year after infusion
- Willingness to attend required follow-up visits
- Voluntary participation with signed informed consent
You will not qualify if you...
- Severe lupus nephritis with serum creatinine over 2.5 mg/dL or need for hemodialysis within 8 weeks before leukapheresis
- Central nervous system diseases such as epilepsy, psychosis, stroke, encephalitis, CNS vasculitis, depression, or suicidal thoughts
- Serious illness affecting vital organs including heart, liver, kidney, blood, or endocrine system
- Immunodeficiency, uncontrolled active infections, or active/recurrent peptic ulcers
- Immunosuppressive therapy within 1 week before leukapheresis
- HIV infection or active hepatitis B or C infection, or syphilis infection
- Active uncontrolled infections of fungal, bacterial, viral, or other types during screening
- Live vaccine treatment within 4 weeks before screening
- Severe allergies or hypersensitivity
- Contraindication to cyclophosphamide combined with fludarabine
- Major surgery within 2 weeks before consent or planned surgery during the trial or within 2 weeks of infusion
- Presence of cannula or drainage tubes other than central venous catheters
- Pregnancy, breastfeeding, or planning pregnancy within 1 year of treatment
- Previous therapy targeting CD19 or BCMA
- Participation in another clinical study within 3 months before enrollment
- Malignant tumors except certain long-term stable skin, cervical, bladder, or breast cancers
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive a single intravenous infusion of GC012F injection (CD19-BCMA CAR-T cells) on Day 0.
Multiple visits including days 4, 7, 10, 14, and weeks 4, 8, and 12 for assessments
Duration - Up to 24 weeks
Participants are monitored for safety and treatment effects after the infusion.
Visits at weeks 24 for follow-up assessments
Trial Site Locations
Total: 1 location
1
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
Q
Qiong Fu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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