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Lintuzumab, a humanized anti-CD33 antibody, targets myeloidleukemia cells and has modest activity against acute myeloidleukemia (AML). To increase the antibodys potency yet avoidnonspecific cytotoxicity seen with -emitting isotopes, lintuzumabwas conjugated to the -emitters bismuth-213 (213Bi) andactinium-225 (225Ac). The 46-minute half-life of 213Bi limits itswidespread use. Therefore, 225Ac was also conjugated to variousantibodies using DOTA-SCN. We conducted a phase I trial of213Bi-lintuzumab and subsequently administered cytarabine with213Bi-lintuzumab in a phase I/II study. The toxicity and biologicalactivity of 225Ac-linutuzumab in patients with relapsed/refractoryAML in a phase I dose-escalation trial was determined. An initialphase I trial demonstrated the feasibility, safety and antileukemicactivity of 213Bi-lintuzumab. 213Bi-lintuzumab producedresponses in 24% of AML patients receiving doses > 37 MBq/kgafter partial cytoreduction with cytarabine. 225Ac-labeledimmunoconjugates killed in vitro at doses at least 1,000 times lowerthan 213Bi analogs. Eighteen patients with relapsed/refractory AMLreceived 18.5 to 148 kBq/kg of 225Ac-lintuzumab in a phase I study.Dose-limiting toxicities were myelosuppression lasting >35 daysin one patient and death due to sepsis in two patients. Themaximum tolerated dose (MTD) was 111 KBg/kg. Bone marrowblast reductions were seen across all dose levels. Targeted -particle immunotherapy with 213Bi- and 225Ac-lintuzumab is safe,has significant antileukemic effects, and can produce remissionsafter partial cytoreduction.

Targeted Alpha-Particle Immunotherapy with Bismuth-213 and Actinium-225 for Acute Myeloid Leukemia