eligibility_summary
Children 6 months–<16 yrs with relapsed CD33+ AML before allo‑SCT: marrow blasts >5% or MRD ≥10−4, eligible/fit with donor, life expectancy ≥12 wks, Lansky ≥70 or ECOG <2. Exclude poor compliance/follow‑up refusal, post‑cytoreduction progression, uncontrolled CNS leukemia, active uncontrolled infection, no donor, weight <6 kg, donor‑specific anti‑HLA to BE‑CAR33, GvHD needing systemic therapy, steroids >0.5 mg/kg/d, hypersensitivity, pregnancy risk/lactation, prior CAR‑T with ≥G3 CRS/CNS toxicity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BE CAR-33, a base-edited, allogeneic anti-CD33 chimeric antigen receptor (CAR) T-cell therapy (biologic/cellular immunotherapy), given as a single IV infusion before allo-HSCT. Mechanism: donor T cells engineered with a CD33-specific CAR to recognize and kill CD33-expressing AML cells, base editing alters select genes to enable function after chemotherapy and to reduce alloreactivity/off-tumor effects (e.g., lowering GVHD risk). Targets: CD33+ AML blasts (myeloid lineage) and CAR T-cell cytotoxic/immune activation pathways.