eligibility_summary
Adults 18–75 with R/R multiple myeloma per SLiM‑CRAB, after ≥3 regimens (incl PI/IMiD/anti‑CD38), refractory to last, with measurable disease, DSA‑negative, adequate renal/hepatic function, contraception, consent. Exclude pregnancy/lactation, poor follow‑up/compliance, prior ≥Gr4 CRS/neurotox, recent anti‑MM/RT/HSCT/DLI or solid organ Tx, CNS disease, GVHD, autoimmune on immunosuppression, high‑dose steroids, major CV/pulmonary disease, active infection/surgery/live vaccine, other cancers, psych issues, HBV/HCV/HIV/HTLV/syphilis/CMV+, hypersensitivity/contraindications.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: allogeneic, umbilical cord blood–derived, dual-targeting BCMA/CD19 CAR-T cells (single IV infusion) after fludarabine/cyclophosphamide (FC) lymphodepletion. Type: gene‑modified cellular immunotherapy (off‑the‑shelf CAR‑T), fludarabine is a purine analog and cyclophosphamide an alkylating agent used to deplete host lymphocytes. Mechanism: CAR‑T cells bind BCMA and CD19 on malignant plasma/B‑lineage cells, triggering T‑cell activation and cytotoxic killing (perforin/granzyme) independent of the native TCR, dual targeting is intended to reduce antigen escape. Targets: BCMA (TNFRSF17) on myeloma/plasma cells, including extramedullary disease, CD19 on B cells/plasmablasts/progenitors, FC depletes host T/B cells to enhance CAR‑T expansion.