Actively Recruiting
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
Led by Essen Biotech · Updated on 2024-10-15
75
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
CONDITIONS
Official 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...
- Adults aged 18 to 90 years
- Total score of 10 or higher on the EULAR/ACR 2019 SLE classification criteria
- SELENA-SLEDAI score of 8 or more
- Presence of CD19 positive B cells
- Hemoglobin level of 85 g/L or higher
- White blood cell count of 2.5 x 10^9/L or higher
- Neutrophil count of 1 x 10^9/L or higher
- Blood platelet count of 50 x 10^9/L or higher
- Liver enzymes (AST/ALT) less than twice the upper normal limit
- Creatinine clearance of 30 mL/min or higher
- Blood bilirubin level of 2.0 mg/dl or less
- Heart ejection fraction of 50% or more as shown by echocardiography
- Adequate venous access for apheresis and no contraindications for leukapheresis
- Negative pregnancy test for women of childbearing age at screening and baseline
- Agreement to use effective contraception during the trial and for at least one year after CAR-T infusion
- Willingness to attend all required follow-up visits
- Voluntary participation with signed informed consent by the patient or legal representative
You will not qualify if you...
- Severe lupus nephritis with serum creatinine above 2.5 mg/dL or need for hemodialysis within 8 weeks before leukapheresis
- Central nervous system diseases including epilepsy, psychosis, encephalopathy, stroke, encephalitis, CNS vasculitis, or psychiatric conditions with depression or suicidal thoughts
- Serious lesions or illness of vital organs such as 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
- HIV infection or active hepatitis B or C virus infection
- Syphilis infection
- Active or suspected uncontrolled fungal, bacterial, viral, or other infections during screening
- Live vaccine received within 4 weeks prior to screening
- Severe allergies or hypersensitivity
- Contraindication to cyclophosphamide combined with fludarabine
- Major surgery within 2 weeks prior to consent or planned surgery during the trial within 2 weeks of infusion
- Presence of cannulas or drainage tubes other than central venous catheters
- Pregnant or breastfeeding women or those planning pregnancy within 1 year of treatment
- Prior treatment with CD19 or BCMA-targeted therapies
- Participation in another clinical study within 3 months before enrollment
- Malignant tumors except certain cancers with long progression-free survival such as non-melanoma skin cancer, cervical cancer in situ, bladder cancer, or breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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