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 I/II clinical trial (HD-CAR-ILD-1)

Condition studied

Therapy-resistant and progressing lung fibrosis in the course of an autoantibody-positive autoimmune disease like Systemic Sclerosis, ANCA-associated Vasculitis, seropositive Rheumatoid Arthritis, Sjögren’s disease, anti-Synthetase Syndrome or other autoimmune diseases

Investigational medicinal product(s)

Eligibility

Primary endpoint

Feasibility is defined to comply with a) successful manufacturing (definition see protocol section 3.4) as well as b) application of a CAR.T-cell product and c) tolerability of the procedure (no grade >3 CRS and no grade > 3 ICANS until V11). The primary endpoint is fulfilled if all prerequisites a)-c) are reached in at least 5/6 patients of the total feasibility cohort (3+3 – see protocol “sample size calculation” above) at V11.

Endpoint detail

toxicities measured according to the Common Terminology Criteria for Adverse Events (CTCAE v6.0) or — in case of CRS or ICANS — according to ASTCT grad-ing, Clinical response is defined by improvement in pulmonary function. Improvement is defined as an increase of FVC by >10% plus an at least stable CO-diffusion capaci-ty, defined as no further decrease of more than - 5% from V3 numbers of TLCO/VA and TLCO SB until EOS (V15 of last patient in