eligibility_summary
Eligible: adults 18–70 with SLE, IMNM, NMOSD, MS, MG, or SSc ≥6 months, active/relapsing despite ≥8 weeks stable SOC and prior ≥2 immunosuppressants/biologics/DMDs, adequate marrow, coagulation, cardio‑pulmonary, liver, and renal function. Exclude: HBV/HCV/HIV/TP+, CMV/EBV DNA+, uncontrolled infection, live vaccine <4 wks, organ/stem‑cell transplant, recent severe CV disease, ≥Gr2 bleeding/long‑term anticoagulation, inadequate washout, prior CAR‑T/gene‑modified T cells, pregnant/lactating, severe CNS disease, cancer <5 yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: C-CAR168, an autologous, second-generation, bispecific CD20/BCMA-directed chimeric antigen receptor T-cell (CAR-T) therapy, delivered as a single IV infusion. Mechanism: Patient T cells are gene-engineered to express a CAR that recognizes CD20 and BCMA, binding triggers T-cell activation, cytotoxic killing, and cytokine release to deplete pathogenic B-lineage cells across maturation stages. Targets: CD20+ B cells (naive and memory) and BCMA+ plasmablasts/long-lived plasma cells. Pathways impacted: B-cell receptor–driven autoimmunity, germinal center activity, autoantibody production, and the BAFF/APRIL–BCMA survival signaling axis, aiming to eliminate autoreactive B cells/plasma cells and reduce autoantibody-mediated tissue damage. Indications: refractory SLE, IMNM, NMOSD, MS, MG, SSc. Phase: early (Phase 1), open-label, single-group.