BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLuminary Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-69 years
Creatinine clearance more than or equal to 30 ml/min calculated by the Cockcroft - Gault formula
Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram.
Adequate pulmonary function with pulse oximetry ≥92% on room air
Disqualifiers
Active neuropsychiatric lupus
Active secondary hemophagocytic lymphohistiocytosis (sHLH)
Presence of any medical or psychological conditions which may affect patient ability to comply with study protocol requirements and study visits
Active microbial infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic. Patients with active tuberculosis must have had at least 4 weeks of appropriate anti-mycobacterial treatment and be asymptomatic.
Trial design
Treatments tested in this trial
- LMY-920
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Luminary Therapeutics
Lead sponsor
Nationwide Children's Hospital
Collaborator
Source ClinicalTrials.gov