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.
Male or female 16-75 years of age, inclusive.
Stable doses of corticosteroids for at least 4 weeks and other immunosuppressives for 8 weeks.
Creatinine clearance more than or equal to 45 ml/min calculated per the 2021 CKD-EPI Creatinine Equation
Participants must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.
Significant disease-related complications
Active thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA)
Current or prior malignancy, unless the malignancy was treated with curative intent and the participant has no known active malignant disease present for ≥ 5 years prior to enrollment.
Symptomatic congestive heart failure.
Sequential
LMY-922
Biological/VaccineAllogeneic CAR-T cell therapy expressing the BAFF-ligand
To evaluate the Incidence and Severity of Treatment-Emergent Adverse Events (Safety) of LMY-922 in Patients ≥16 Years of Age with Refractory Autoimmune Disease
Incidence and severity of treatment-emergent adverse events
To determine the recommended Phase II dose of LMY-922 based on Incidence of dose limiting toxicities in patients with refractory autoimmune disease.
Incidence of dose limiting toxicities (DLT)
Response in Rheumatoid Arthritis: Chage from Baseline DAS28-CRP Score
Change from baseline in DAS28-CRP score at 3 and 6 months.
Response in Systemic Lupus Erythematosus: Change in Systemic Lupus Erythematosus Disease Activity Index
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) at 3 and 6 months.
Response in Dermatomyositis: Core Set Measurement Total Improvement Score improvement rate.
Core Set Measurement Total Improvement Score (CSM TIS) 20/40/60 improvement rate.
Response in Systemic Sclerosis: Change in Modified Rodnan Skin Score
Change from baseline in the Modified Rodnan Skin Score (mRSS) at 3 and 6 months.
Drug-free remission and response
Duration of drug-free remission and response
Serum soluble BR3
Serum soluble BR3 pre and post infusion and the correlation with clinical response
Serum soluble TACI
Serum soluble TACI pre and post infusion and the correlation with clinical response
Serum soluble BCMA
Serum soluble BCMA pre and post infusion and the correlation with clinical response
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