A Phase I Study of BAFF CAR-T Cells (LMY-920) for Treatment of Systemic Lupus Erythematosus
Luminary Therapeutics
Summary
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.
Description
This is an open label, phase 1 dose escalation study designed to establish the safety and RP2D of autologous BAFF CAR-T cells in adults with refractory SLE. The planned dose escalation includes 3 dose levels and one de-escalation level. The maximum tolerated dose (MTD) will be determined using a 3+3 dose escalation design. The MTD dose level cohort may be expanded to a total of 6 patients. RP2D may be selected at dose level(s) at or below the MTD based on all data then available (e.g. efficacy, safety, PK and PD), and additional patients enrolled at these levels to expand up to a total of 40 p…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-69 years * Confirmed Systemic Lupus Erythematosus (SLE) as per Systemic Lupus International Collaborating Clinics (SLICC) 2012 Criteria with one or more of the following: a. Active disease despite use of standard therapy (i) and one or more additional therapies (ii). i. Corticosteroids (CS), Hydroxychloroquine ii. Mycophenolate mofetil (MMF), Methotrexate (MTX), Azathioprine (AZA), Tacrolimus (TAC), Cyclophosphamide (CYC), Rituximab, and/or belimumab b. Active disease due to intolerance of standard therapy (i) and one or more additional therapies (ii). c.…
Interventions
- BiologicalLMY-920
CAR T Therapy
Location
- Nationwide Children'sColumbus, Ohio