Actively Recruiting
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Led by Gracell Biotechnologies (Shanghai) Co., Ltd. · Updated on 2026-04-08
118
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
Sponsors
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
CONDITIONS
Official Title
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years old
- Able and willing to comply with study visits and protocol requirements
- Presence of CD19 positive B cells in peripheral blood
- Diagnosed with SLE meeting 2019 EULAR/ACR classification criteria
- Previously treated with standard SLE regimens including at least one biological agent for more than 6 months without achieving Lupus Low Disease Activity State
- SLEDAI-2000 score of 8 or higher at screening; clinical symptoms score (excluding low complement and/or anti-ds-DNA antibody) at least 4 if those lab values are available
- Positive autoantibody tests: ANA and/or anti-ds-DNA and/or anti-Sm antibodies
- Adequate organ function including minimum blood counts, liver enzymes within limits, creatinine clearance ≥40 mL/min, heart function with LVEF ≥45%, oxygen saturation ≥92%, and no significant pleural or pericardial effusion
- Females of childbearing potential must have negative pregnancy test, agree to use effective contraception from screening until at least 1 year after infusion, and avoid breastfeeding during this time
- Male participants must agree to use condoms during sexual contact with females of childbearing potential for at least 1 year after infusion
- Venous access available for blood collection and no contraindications for leukapheresis
You will not qualify if you...
- Prior treatment with CD19 and/or BCMA-targeted therapies or CAR T-cell therapies
- Receipt of CD20-targeted drugs within 6 months before screening
- Use of immunosuppressants or prednisone >15 mg/day within 1 week before apheresis
- Serious renal disorders including severe lupus nephritis or need for dialysis within 8 weeks prior to apheresis
- Serious heart conditions such as NYHA class III/IV heart failure, recent myocardial infarction or coronary bypass within 6 months, significant arrhythmias, prolonged QTc interval, or severe cardiomyopathy
- Need for supplemental oxygen or mechanical ventilation with oxygen saturation <92%
- Uncontrolled hypertension
- History of central nervous system or neurodegenerative diseases
- Recent significant bleeding or thrombosis events within specified timeframes
- Active or recent malignancy within 5 years except certain early-stage treated cancers
- Immunodeficiency or active infections requiring systemic therapy
- Positive for HIV, hepatitis B or C markers, or syphilis antibodies unless viral loads are undetectable
- Receipt of live vaccines within 4 weeks before apheresis
- History of severe allergies or hypersensitivity to study drugs or components
- Recent surgeries within 2 weeks before apheresis or planned surgeries during the study except minor local anesthesia procedures
- Pregnant or lactating women not agreeing to avoid breastfeeding, and participants with fertility plans during the study or within 1 year after treatment
- Participation in other clinical trials within 4 weeks prior to consent or within 5 half-lives of previous study drug
- Any condition that may interfere with study participation or safety as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Research Site
Shanghai, China
Actively Recruiting
2
Research Site
Wuhan, China, 430060
Active, Not Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center, Doctor
CONTACT
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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