eligibility_summary
Adults ≥18, >45 kg, controlled BP, on stable SLE/LN therapy ≥4 wks. SLE by 2019 EULAR/ACR or 2012 SLICC with positive ANA/dsDNA/Smith. SLE activity: SLEDAI-2K ≥6 (≥4 clinical), BILAG A≥1 or B≥2, Physician Global ≥1. LN: active biopsy-proven class III/IV (2018 ISN/RPS). Exclude other significant illness/autoimmune disease, rapidly progressive GN, active CNS lupus, transplants, prior B-cell-directed cell therapy (incl. CAR-T or bispecific/TCE therapy), or drug-induced SLE. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06153095 (withdrawn). Intervention: IMPT-514, an autologous, gene‑modified bispecific CAR T‑cell therapy (biologic/cellular therapy) engineered to target CD19 and CD20. Mechanism: patient T cells are transduced with a CAR recognizing CD19 and CD20 to deplete pathogenic B‑cell populations, aiming to suppress B‑cell–driven autoimmunity and autoantibody production in refractory SLE and lupus nephritis. Conditioning: lymphodepleting chemotherapy with fludarabine (purine analog, inhibits DNA synthesis, depletes lymphocytes) and cyclophosphamide (alkylating agent, cytotoxic lymphodepletion) to promote CAR T expansion/persistence. Targets: B‑lineage cells expressing CD19 (including early B cells and plasmablasts) and CD20 (mature B cells), pathways impacted include B‑cell receptor/activation and autoantibody generation.