eligibility_summary
Inclusion: 18–65, SLE (2019), SLEDAI‑2K ≥8 with ANA≥1:80 or anti‑dsDNA/Sm+, active organ disease, adequate labs, LVEF ≥45%, no pregnancy/contraception, failed ≥6 mo std tx incl biologic or intolerant, CD19+ B cells. Exclude: recent cancer/surgery, severe allergy, severe nephritis, serious CNS/CV disease, serious infections (HBV/HCV/HIV/CMV/syphilis) or untreated LTBI, live vaccine, prior/planned transplant or CAR‑T, recent disallowed SLE therapy, Ig deficiency, other autoimmune disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06340490 tests RJMty19, an off‑the‑shelf, lentiviral anti‑CD19 chimeric antigen receptor double‑negative T‑cell (CAR‑DNT) therapy (gene‑modified cellular immunotherapy) for refractory SLE. Patients receive lymphodepleting cyclophosphamide (alkylator) and fludarabine (purine analog) before a single infusion (dose escalation 5×10^6, 1×10^7, 2×10^7 CAR+ cells/kg, then expansion). Mechanism: CAR‑DNT cells recognize CD19 and selectively kill CD19+ B‑lineage cells, aiming to deplete autoreactive naïve/memory B cells and plasmablast precursors, thereby reducing autoantibody production and B‑cell–driven immune activation. Targets: CD19+ B cells, B‑cell/autoantibody pathway and related adaptive immune interactions. Primary aims: safety, MTD/RP2D, PK, preliminary efficacy.