eligibility_summary
Adults (>18) with MM (IMWG), measurable extramedullary lesion ≥1 cm, ≥2 prior lines (PI+IMiD), ECOG 0–1, life expectancy ≥3 mo, apheresis-eligible, adequate labs: Hb ≥80, ANC ≥1, Plt ≥50, ALC ≥0.3, AST/ALT ≤3×ULN, bili ≤2×ULN, CrCl ≥40. Exclude: weight >105 kg or height >185 cm, nickel/Pd sensitivity, claustrophobia, prior CAR‑T/anti‑BCMA, recent steroids/therapy/live vaccines, active cancers, CNS MM, HIV/HBV/HCV, major infection/autoimmune/neurologic/cardiac disease, recent transplant/surgery, pregnancy, frailty ≥2.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib, single-arm study in relapsed/refractory multiple myeloma with extramedullary disease. Intervention: cilta-cel (JNJ-68284528), an autologous BCMA-directed CAR-T cell therapy (genetically modified CD3+ T cells). Mechanism: CAR recognition of BCMA on malignant plasma cells activates T-cell cytotoxicity. Up to 30% of the cilta-cel dose is labeled with 64Cu-SPION, a copper-64–labeled superparamagnetic iron oxide nanoparticle (dual PET-MR imaging agent) to track in vivo CAR-T trafficking, imaging agent is for visualization, not treatment. Targets: BCMA (TNFRSF17) on myeloma plasma cells, study investigates T-cell homing/trafficking to extramedullary lesions and related immune effector pathways.