eligibility_summary
Inclusion: adults ≥18, consented, ECOG 0–1, confirmed MM per IMWG with measurable, progressive disease, ≥3 prior lines incl. PI, IMiD, and anti‑CD38, adequate marrow/organ function. Exclusion: other active cancer (except cured ≥2 y or treated non‑melanoma skin CA), serious cardiac disease (NYHA III–IV, MI/CABG ≤6 mo, significant arrhythmia/syncope, severe non‑ischemic cardiomyopathy), recent SCT (allo <6 mo/off IS 6 wk w/o GVHD, auto <12 wk), CNS MM, plasma cell leukemia, Waldenström’s, POEMS, AL amyloidosis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: GC012F (AZD0120) is an autologous, genetically modified CAR T-cell therapy (biological) administered as a single infusion. Mechanism of action: T cells are engineered with dual CARs targeting BCMA and CD19, antigen binding activates CAR signaling (CD3ζ/co-stimulation), driving T-cell cytotoxicity (immune synapse formation, perforin/granzyme release, cytokines) to eliminate malignant cells and reduce antigen-escape. Cells/pathways targeted: BCMA (TNFRSF17) on malignant plasma cells/myeloma cells and CD19 on B-lineage cells (including myeloma-propagating clones), impacting B-cell maturation/survival pathways and depleting the myeloma/B-cell compartments.