eligibility_summary
Eligible: Multiple myeloma (IMWG2014), high-risk (mSMART 3.0), BCMA+, ECOG 0–2, LVEF ≥50%, no active lung infection, life expectancy >3 months, consent, any age/sex. Exclude: CNS disease/epilepsy, prolonged QT or serious heart disease, pregnancy/lactation, active infection (incl. HBV/HCV/HIV), prior gene therapy, poor T-cell proliferation (<5× with CD3/CD28), significant renal/hepatic dysfunction, uncontrolled disease, or investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BCMA CAR‑T cells—an autologous, genetically modified cellular immunotherapy (gene‑engineered T‑cell therapy). Mechanism of action: Patient T cells are transduced to express a chimeric antigen receptor that binds B‑cell maturation antigen (BCMA/TNFRSF17) on malignant plasma cells, enabling TCR‑independent recognition and cytolysis via perforin/granzyme release, with T‑cell activation (CD3ζ signaling), proliferation, and cytokine secretion driving tumor killing and persistence. Targets: BCMA‑positive plasma cells in multiple myeloma, impacts B‑lineage cells expressing BCMA and engages T‑cell effector pathways. Design: single‑arm, open‑label Phase 2 trial (IV infusion) in newly diagnosed high‑risk MM to assess safety/efficacy.