Actively Recruiting
Open-Label, Non-Randomized, Single-Arm Phase 1/2 Study of Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
18
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of CD19 CAR T cell therapy for treating patients with refractory systemic lupus erythematosus (SLE), including those with lupus nephritis (LN). This Phase I/II open-label, non-randomized trial aims to find the best dose and evaluate response rates in this patient group. The study is led by Beijing GoBroad Hospital and will enroll 18 participants aged 3 to 65 years who have not responded to standard treatments. Patients will first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. After this, they will be given a single dose of CD19 CAR T cells. The trial has two phases: Phase I focuses on safety and determining the recommended dose, while Phase II will assess how well the treatment works. Treatment effects and side effects will be monitored for up to two years following infusion. Participants will undergo regular assessments including monitoring for dose-limiting toxicities within 28 days post-infusion, adverse events up to two years, and measurements of treatment response at 3 and 6 months. Additional evaluations will include pharmacokinetics and overall survival. Participants will be followed closely to understand the treatment’s impact and manage any side effects throughout the study duration.
CONDITIONS
Brief Title
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 3 to 65 years
- Diagnosed with systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR classification criteria
- Positive antinuclear antibody (ANA) test or positive anti-dsDNA serum antibody test
- Refractory SLE or refractory lupus nephritis demonstrated by specific treatment failure or relapse criteria
- Presence of CD19+ B cells and ability to stop immunosuppressive drugs for more than 1 week
- Blood lymphocyte count above 1 x 10^9/L with no contraindication to cell collection
- No severe allergies
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Expected survival of at least 90 days
- Ability to understand and sign informed consent
You will not qualify if you...
- Impaired consciousness or intracranial hypertension with pressure above 15 mmHg or brain conditions needing intervention
- Symptomatic congestive heart failure, severe arrhythmia, or significant ECG abnormalities
- Severe respiratory failure or pulmonary hypertension requiring oxygen
- Active acute or chronic respiratory diseases unrelated to SLE
- Presence of other malignancies
- Disseminated intravascular coagulation (DIC)
- Uncontrolled infections or sepsis
- Uncontrolled diabetes with specified glucose or HbA1c levels
- Serious mental illness impairing consent or treatment
- Active intracranial lesions on MRI
- History of organ transplantation (except stem cell transplant)
- Pregnancy or breastfeeding
- Positive tests for hepatitis, AIDS, or syphilis
- Inability to collect peripheral blood mononuclear cells for CAR T manufacturing
- Severe kidney impairment with eGFR below 30 ml/min/1.73m2
- Inability to stop immunosuppressive agents for 7 days or disease relapse during withdrawal
- Active skin diseases interfering with SLE evaluation such as psoriasis, dermatomyositis, or drug-induced lupus
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 - A few days prior to infusion
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine before CAR T cell infusion.
1 to 2 visits (in-person)
Duration - 1 day (single dose)
Participants receive a single dose of CD19 Chimeric Antigen Receptor (CAR) positive T cells.
1 infusion visit (in-person)
Duration - Up to 2 years post infusion
Participants are monitored for safety, adverse events, and treatment response following infusion.
Multiple visits including assessments at 28 days, 3 months, 6 months, and periodically up to 2 years
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
T
Tengyu Wang
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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