eligibility_summary
Incl: 18–70, SLE (2012 SLICC/2019 EULAR‑ACR), active despite stable steroids/IS/biologics (prednisone 7.5–60 mg/d if alone), ANA/anti‑dsDNA/Sm+, SELENA‑SLEDAI‑2K ≥7, active organ disease, no infection, adequate organ function, contraception, β‑hCG−. Excl: severe lupus nephritis or crisis, major CNS disease, other autoimmune needing tx, prior transplant or CAR‑T, active HBV/HCV/HIV/syphilis (HBV DNA− allowed), serious CV dz, investigational drug, bleeding/anticoagulants, live vaccine, allergy to product/DMSO, suicidality, malignancy (some in situ ok), pregnancy/lactation, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06297408 tests Relma-cel (relmacabtagene autoleucel), an autologous, gene‑modified cellular immunotherapy: CD19‑directed chimeric antigen receptor (CAR) T cells. Phase I is single‑arm to assess safety/tolerability and define the RP2D, Phase II randomizes Relma‑cel vs conventional therapy ± biologics to assess efficacy (LLDAS) in moderate–severe active SLE. Mechanism of action: patient T cells are engineered ex vivo to express an anti‑CD19 CAR, after infusion they recognize and kill CD19‑expressing cells via CAR‑mediated cytotoxicity. Targets: CD19+ B‑lineage cells (naive and memory B cells and plasmablasts), aiming to deplete autoreactive B cells, suppress B‑cell receptor–driven humoral autoimmunity, and reduce autoantibody production (e.g., anti‑dsDNA/ANA), with potential immune “reset” following B‑cell aplasia. Background meds may include corticosteroids, immunosuppressants, or biologics as needed. Status: not yet recruiting, China, multicenter, sponsor Shanghai Ming Ju Biotechnology.