eligibility_summary
Eligibility: Adults 18–80, ≥40 kg, multiple myeloma with NY‑ESO‑1 by IHC and HLA‑A02:01+, relapsed/refractory (≥4 prior lines incl PI, IMiD, anti‑CD38, BCMA) with measurable disease, or R/R plasma cell leukemia (≥2 regimens). ≥2 wks from last therapy, prior transplant/cell therapy allowed. Need KPS>50%, adequate organ/marrow, no active infection, no ≥20 mg steroids, no live vaccines/bridging therapy. Infusion delayed for uncontrolled arrhythmia, pressor‑dependent hypotension, or infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: 1) NY-ESO-1 TCR/IL-15 NK cells—an allogeneic, cord blood–derived NK cell therapy engineered to express an HLA-A02:01–restricted NY-ESO-1–specific T-cell receptor plus IL-15 (“armored”) to enhance activation, proliferation, and persistence, mediates tumor killing via the introduced TCR and native NK cytotoxicity (perforin/granzyme, NKG2D). 2) Lymphodepletion with cyclophosphamide (alkylating chemotherapy, DNA cross-linker) and fludarabine (purine analog antimetabolite) to improve engraftment/persistence. Targets/cells/pathways: NY-ESO-1 cancer-testis antigen on myeloma plasma cells presented by HLA-A02:01, TCR signaling, IL-15/STAT5 survival pathway, host lymphocyte depletion to limit rejection of infused NK cells.