eligibility_summary
Inclusion: Consent, age 18–75, IMWG-defined relapsed/refractory MM, BCMA+, no antibody Rx ≤2 wks, ECOG 0–2, Hgb ≥70 g/L, Plt ≥30×10^9/L, adequate organs (Cr ≤1.5×ULN or CrCl >30, LVEF ≥50%, SpO2 >90%, TBil ≤1.5×ULN, ALT/AST ≤2.5×ULN). Exclusion: other malignancy ≤3 yrs or advanced, cardiac disease, GVHD, severe lung disease, uncontrolled infection, autoimmune/immunodeficiency, active HBV/HCV, HIV/syphilis, severe allergy, CNS disorders, pregnant/lactating or fertility plan ≤12 mo, other.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Nanobody-based biepitope BCMA-targeting CAR-T cells (autologous cellular gene therapy). Patient T cells are engineered with a CAR containing two single-domain antibody (nanobody) binding regions that recognize two distinct epitopes on BCMA (TNFRSF17). Mechanism of action: Dual-epitope BCMA binding increases avidity and breadth, aiming to prevent antigen-escape seen with single-epitope CARs and potentially limit excessive pro-inflammatory cytokine release. Upon BCMA engagement, CAR signaling activates T-cell cytotoxicity (perforin/granzyme) and cytokine-mediated killing of myeloma cells. Targets: BCMA-expressing malignant plasma cells in relapsed/refractory multiple myeloma, incidental depletion of normal BCMA+ plasma cells. Pathways/cells engaged: BCMA on plasma cells, T-cell activation via CAR signaling modules (e.g., CD3ζ with costimulation), leading to immune-mediated tumor cell lysis. Phase 1/2, single-arm, multicenter (China).