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CAR T-cell Therapy
BAFF CAR-T Cells for Lupus
Phase 1
Waitlist Available
Research Sponsored by Luminary Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and appropriate dosage of a new treatment called BAFF-ligand CAR-T cells in adults with a specific type of lupus. Researchers believe that this new treatment may
Who is the study for?
This trial is for adults aged 18-69 with active systemic lupus erythematosus (SLE) who haven't responded to standard treatments like corticosteroids and hydroxychloroquine, or other drugs such as methotrexate. Participants must have a creatinine clearance of at least 30 ml/min, stable heart function with an ejection fraction ≥40%, good lung function (pulse oximetry ≥92% on room air), and liver enzymes within acceptable limits.
What is being tested?
The study is testing the safety and optimal dose for phase 2 of LMY-920, which are CAR-T cells targeting BAFF-ligand in patients with refractory SLE. The goal is to see if these modified immune cells can safely improve disease activity scores in SLE patients.
What are the potential side effects?
Potential side effects may include typical CAR-T cell therapy reactions such as cytokine release syndrome, which can cause fever, fatigue, headache, rash; neurologic symptoms; low blood cell counts leading to increased infection risk; and possible organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recommended Phase 2 Dose (RP2D)
Safety of the Treatment
Secondary study objectives
Efficacy of the Treatment: BILAG
Efficacy of the Treatment: PGA
Efficacy of the Treatment: SELENA-SLEDAI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BAFF CAR TExperimental Treatment1 Intervention
Autologous BAFF CAR T Therapy
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Who is running the clinical trial?
Nationwide ChildrenUNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
Luminary TherapeuticsLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Dean Lee, PhDStudy ChairNationwide Children
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