Actively Recruiting
T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus Patients With or Without Organ Involvement
Led by Essen Biotech · Updated on 2024-10-15
75
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Systemic lupus erythematosus (SLE) is an autoimmune disorder where the immune system attacks the body's own tissues, causing inflammation and damage to multiple organs. This trial investigates a new treatment using CD19-BCMA CAR-T cells to target and eliminate the abnormal B cells responsible for producing harmful autoantibodies in patients with resistant SLE. The purpose is to find the highest dose of this therapy that patients can tolerate safely. Participants will receive chemotherapy drugs fludarabine phosphate and cyclophosphamide intravenously as preparation for the CAR-T cell infusion. On day 0, they will be given CD19/BCMA-CAR T cells through an intravenous infusion lasting 10 to 20 minutes. Patients who respond well and tolerate the initial dose without serious side effects may receive 2 or 3 additional doses of the CAR-T cells. Throughout the study, participants will be closely monitored for any toxic side effects during the first 28 days after infusion. Researchers will assess how well the CAR-T cells are produced and expanded in the lab before infusion. Follow-up visits will continue to evaluate safety and treatment response, including blood tests, heart function checks, and other clinical assessments. The total study duration includes initial treatment and follow-up periods to track patient outcomes.
CONDITIONS
Brief Title
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Total score of at least 10 on the EULAR/ACR 2019 SLE classification criteria
- SELENA-SLEDAI score of 8 or higher
- 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) below twice the upper normal limit
- Creatinine clearance of at least 30 mL/min
- Blood bilirubin level of 2.0 mg/dL or less
- Heart ejection fraction of at least 50% by echocardiography
- Adequate venous access for apheresis with no contraindications
- Negative pregnancy test for women of childbearing age at screening and baseline
- Agreement to use effective contraception during the trial and for at least 1 year after CAR-T infusion
- Commitment to attend follow-up visits
- Voluntary participation with signed informed consent
You will not qualify if you...
- Severe lupus nephritis with serum creatinine above 2.5 mg/dL within 8 weeks before leukapheresis or need for hemodialysis
- Central nervous system diseases such as epilepsy, psychosis, encephalopathy, stroke, encephalitis, CNS vasculitis, or psychiatric conditions with depression or suicidal thoughts
- Serious lesions or history of illness in vital organs including heart, liver, kidney, blood, or endocrine system
- Immunodeficiency, uncontrolled active infections, or active/recurrent peptic ulcers
- Immunosuppressive therapy received within 1 week prior to leukapheresis
- Infection with HIV, active hepatitis B or C virus, or syphilis
- Presence or suspicion of uncontrolled active fungal, bacterial, viral, or other infections during screening
- Live vaccine treatment within 4 weeks prior to screening
- Severe allergies or hypersensitivity
- Contraindication to cyclophosphamide combined with fludarabine
- Major surgery within 2 weeks before informed consent or planned surgery during the trial or within 2 weeks of infusion
- Presence of cannula or drainage tubes other than central venous catheters
- Pregnant or breastfeeding women or planning pregnancy within 1 year of treatment
- Previous CD19 or BCMA-targeted therapy
- Participation in any clinical study within 3 months before enrollment
- Malignant tumors except certain skin, cervical, bladder, or breast cancers with good prognosis
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 - Approximately 1 week including chemotherapy and initial CAR T cell infusion
Participants receive chemotherapy with fludarabine phosphate and cyclophosphamide followed by infusion of CD19/BCMA-CAR T cells. Eligible participants may receive 2 or 3 additional CAR T cell doses based on response and safety.
Multiple visits over about 1 week including days -4 to 0 for chemotherapy and CAR T cell infusion
Duration - At least 28 days after infusion
Participants are monitored for safety, including dose limiting toxicities, and response after treatment.
Regular follow-up visits for safety assessment during 28 days post-infusion
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, 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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