eligibility_summary
Adults 18–70 with adequate labs/organ function, SpO2 ≥92%, LVEF ≥50%, negative pregnancy test, agree to protocol contraception. Cohorts: SLE (EULAR/ACR 2019 or SLICC 2012, ANA/dsDNA/Sm+, SLEDAI-2K >6, clinical ≥4), diffuse cutaneous SSc ≤6 yrs, AAV (MPA/GPA/EGPA) with MPO- or PR3-ANCA+, IIM (2017, active: ≥2 core measures), primary SS with anti-SSA and ESSDAI ≥5. Exclude uncontrolled SLE crisis, IIM CK ≥120×ULN, recent infection, HBV/HCV/HIV/syphilis, pregnancy, or other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: RD06-04, an autologous anti-CD19 CAR T‑cell therapy (genetically engineered cellular immunotherapy) given IV after lymphodepletion with fludarabine (purine analog, lymphocyte‑depleting) and cyclophosphamide (alkylating agent). Mechanism: CAR T cells bind CD19 and ablate CD19+ B‑cell compartments (naive, memory, and plasmablasts), aiming to suppress autoreactive B cells, reduce autoantibody production (e.g., anti‑dsDNA, MPO/PR3‑ANCA, anti‑SSA), and dampen B cell–mediated antigen presentation and cytokine/co‑stimulatory signaling. Targets: CD19 on B‑lineage cells, downstream autoantibody/immune‑complex pathways implicated in SLE, SSc, AAV, IIM, and pSS. Design: open‑label, single‑arm Early Phase 1 IIT in China, assessing safety, PK/PD, and efficacy. Status: recruiting.