A Phase 1 Study of Allogeneic (γ/δ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Luminary Therapeutics
Summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.
Description
LMY-922 is an allogeneic CAR-T cell therapy consisting of allogeneic cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate pathological B cells. BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on the B cells of pati…
Eligibility
- Age range
- 16–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants must meet all the following inclusion criteria to be eligible for enrollment: 1. Male or female 16-75 years of age, inclusive. 2. For participants with: a. Rheumatoid Arthritis: i. Meets criteria for seropositive, adult-onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, or seropositive (rheumatoid factor positive) polyarticular juvenile arthritis as defined by the International League of Associations for Rheumatology (ILAR) classification criteria for at least 3 mo…
Interventions
- BiologicalLMY-922
Allogeneic CAR-T cell therapy expressing the BAFF-ligand
Location
- Boston Children's HospitalBoston, Massachusetts