Treatment of patients with autoantibody-positive autoimmune diseases and severe interstitial lung fibrosis
*with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector – a single-center phase Ib clinical trial
Lung fibrosis is a life-limiting complication of various autoimmune diseases. Its therapy can - at its best - slow down the progression, but definitively not revert it. The interaction of B-lymphocytes and fibroblasts is centrally involved in the pathogenesis of fibrosis. The scientists therefore hypothesize that a deep depletion of B-lymphocytes will ameliorate lung fibrosis.
To achieve this goal, they will infuse autologous chimeric antigen receptor (CAR) T cells targeting CD19-positive B-cells. Primary and secondary endpoints include safety and efficacy endpoints, including patient-reported outcome measures. In a first patient with rapidly progressing systemic sclerosis there were no relevant safety aspects and the team could indeed document a remarkable reduction of pulmonary fibrosis.
In this study they plan to expand this approach to 10 patients with autoantibody positive lung fibrosis with a post-treatment observation of 12 months.
Further information here.