eligibility_summary
Inclusion: Adults 18–70 with refractory/relapsed myeloma, limited options, >12-wk survival, KPS>50, ALT/AST<3×ULN, bilirubin<2 mg/dL, no serious organ disease, post‑HSCT/cell therapy relapse/no remission or transplant‑ineligible, eligible for leukapheresis, consent. Exclusion: pregnant/lactating or planning pregnancy, HIV, active TB, or active HBV/HCV, poor T‑cell transfection/expansion, abnormal vitals or noncooperation, severe allergy incl IL‑2, active infection, severe autoimmune disease, other reasons.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06196255 tests anti‑FcRL5 CAR‑T cell therapy for relapsed/refractory multiple myeloma. Intervention: autologous, gene‑modified chimeric antigen receptor T cells (cellular immunotherapy), infused after lymphodepleting chemotherapy with fludarabine (purine analog, lymphocyte DNA synthesis inhibitor) and cyclophosphamide (alkylating agent, DNA crosslinker). Mechanism: CAR‑T cells recognize Fc receptor–like 5 (FcRL5/CD307e) on malignant plasma cells, triggering T‑cell activation via CAR signaling domains (e.g., CD3ζ/costim), expansion, and cytotoxic killing (perforin/granzyme) with cytokine release. Targets: FcRL5‑positive multiple myeloma/plasma cells (B‑lineage), impacting humoral B‑cell compartments, engages T‑cell activation/cytotoxic pathways and reduces host lymphocytes to promote CAR‑T engraftment.