eligibility_summary
Include: 18–60, consent, able to do LP/blood/MRI, SPMS or PPMS (2017), ≤15 yrs from onset, EDSS 3–6.5, EDSS rise ≥1.0 in 24 mo, no relapses in 24 mo, no Gd+ lesions, vaccinated ≥6 wks pre‑lymphodepletion. Exclude: RMS/active PMS, other CNS disease, major CV disease, PML, active/chronic infections (HBV/HCV) or TB, >400 mL blood loss, prior stem cell/organ/gene therapy, LP/MRI contraindications, pregnant/nursing, splenectomy, serious comorb., recent thromboembolism/coagulopathy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06675864 tests rapcabtagene autoleucel (YTB323), an autologous, gene‑modified chimeric antigen receptor T‑cell (CAR‑T) therapy delivered as a single IV infusion to participants with non‑active progressive MS. Drug type: biological, personalized cell therapy (anti‑CD19 CAR‑T). Mechanism of action: patient T cells are engineered to express a CAR recognizing CD19, upon engagement they activate cytotoxic effector functions to eliminate CD19+ B‑lineage cells. Intended immunologic effect: sustained depletion of pathogenic B cells and plasmablasts, reducing B‑cell antigen presentation to autoreactive T cells, dampening B/T crosstalk, and limiting compartmentalized CNS inflammation implicated in progression. Primary cellular/ pathway targets: CD19+ B cells (naive/memory B cells and plasmablasts), with downstream impact on autoantibody and pro‑inflammatory cytokine pathways driving progressive MS.