eligibility_summary
Donors: ≥18, ≥3/6 haplo‑related family, have R/R CD19+ recipient. Cohort B: recipient/patient unsuitable for autologous CAR T (prior CAR T/leukapheresis/manufacturing failure or cannot apherese). Patients: ≤21 with measurable marrow R/R CD19+ leukemia, A: prior HCT from donor, B: no donor HCT + autologous CAR T unsuitable, life ≥8 wk, PS ≥50, no CNS‑3, post‑HCT recovered, adequate organs, no severe infection, not pregnant, therapy washouts. Exclusions: none.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT04881240 (Phase I, recruiting). Intervention: Allogeneic memory (CD45RA–) CD19 CAR T cells with 4‑1BB/CD3ζ signaling (biologic cell therapy), lymphodepletion with cyclophosphamide (alkylating chemotherapy) and fludarabine (purine analog antimetabolite), mesna (uroprotectant). Manufacturing/collection: donor leukapheresis and CliniMACS selection. Mechanisms: CAR T cells bind CD19 on B‑lineage leukemia cells, activating cytotoxicity via CD3ζ, 4‑1BB costimulation enhances T‑cell persistence. Selecting CD45RA– memory T cells aims to improve persistence and potentially reduce GVHD. Cells/pathways targeted: CD19+ B cells, T‑cell activation/costimulation pathways (CD3ζ, 4‑1BB), host lymphocyte depletion to facilitate CAR T expansion. Population: ≤21 years with relapsed/refractory CD19+ leukemia, cohorts by prior transplant from the CAR T donor. Primary aim: safety/MTD, secondary: anti‑leukemic activity and GVHD rates.