eligibility_summary
Eligibility: Adults 18–80, ≥40 kg, CD5+ (≥30%) hematologic malignancy, R/R T‑cell neoplasms, CLL/SLL/Richter’s after ≥2 lines incl BTKi+BCL2i, or MCL after ≥2 lines incl BTKi, KPS >50, adequate organs, ≥1 wk from chemo, consent and contraception. Exclude: pregnancy/lactation, uncontrolled infection (HBV/HCV, HIV viremia), CNS disease, GVHD, recent surgery/SCT/immunosuppression, active autoimmune (12 mo), other active cancer, concurrent agents, ≥G3 tox.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: iC9/CD5CAR/IL-15 cord blood–derived NK cells (allogeneic CAR-NK cell therapy), plus lymphodepleting chemotherapy with fludarabine phosphate (IV purine analog/antimetabolite) and cyclophosphamide (IV alkylating agent). Mechanisms: The CD5-directed CAR redirects NK cytotoxicity to CD5-expressing malignant lymphocytes, the constitutive IL-15 transgene promotes NK survival, proliferation, and persistence, the iC9 safety switch allows rapid ablation of the cells if severe toxicity occurs. Fludarabine and cyclophosphamide deplete host lymphocytes to improve CAR-NK expansion and activity. Cells/pathways targeted: CD5 on T-cell malignancies and CD5+ B-cell tumors (CLL/SLL, mantle cell lymphoma), NK effector pathways (perforin/granzyme), and IL-15–JAK/STAT signaling supporting NK function.