Actively Recruiting
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Led by Luminary Therapeutics · Updated on 2025-06-03
18
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
L
Luminary Therapeutics
Lead Sponsor
N
Nationwide Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.
CONDITIONS
Official Title
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 69 years
- Confirmed Systemic Lupus Erythematosus (SLE) according to SLICC 2012 Criteria
- Active disease despite standard therapy including corticosteroids, hydroxychloroquine, and additional immunosuppressive therapies, or active disease due to intolerance of standard therapy, or steroid-dependent disease
- Creatinine clearance of 30 ml/min or higher
- Left ventricular ejection fraction of 40% or greater on recent echocardiogram
- Pulmonary function with pulse oximetry of 92% or higher on room air
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (except Gilbert's syndrome)
- ALT and AST less than 3 times the institutional upper limit of normal
You will not qualify if you...
- Active neuropsychiatric lupus
- Active secondary hemophagocytic lymphohistiocytosis (sHLH)
- Medical or psychological conditions that may impair compliance with study requirements
- Active untreated microbial infections, or recent fungal infections without at least 2 weeks of therapy and symptom resolution
- Active or latent hepatitis B or active hepatitis C within 8 weeks of screening
- HIV positive within 8 weeks of screening
- Acute or ongoing neurologic toxicity above Grade 1 except controlled seizures or stable neurologic deficits
- Known genetic syndromes causing bone marrow failure (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome)
- Evidence of myelodysplasia or cytogenetic abnormalities prior to therapy
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test and use effective contraception during and 6 months after treatment
- Men must agree to abstain or use effective contraception and refrain from sperm donation during and 6 months after treatment
- Live vaccines within 2 weeks prior to enrollment
- Less than 28 days since prior investigational treatment and lymphocyte collection
- Concurrent high-dose systemic steroids or T cell-directed immune suppression; prednisone must be tapered to 10 mg/day or less before leukapheresis
- Previous gene or adoptive cell therapy
- Serious uncontrolled diseases that may interfere with therapy or assessments
- Active malignancy except non-melanoma skin cancer or carcinoma in situ; prior malignancies with low risk of interference may be allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nationwide Children's
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Matthew A Spear, MD
CONTACT
J
Jeff Liter, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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