CLRB - Cellectar commences pivotal trial of CLR 131 in a rare form bone marrow cancer

Cellectar Biosciences ([[CLRB]] +4.3%) has initiated a pivotal trial in the U.S., for CLR 131 in Waldenstrom’s macroglobulinemia ((WM)), a rare cancer of the bone marrow and lymphatic tissues.The pivotal trial is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. This design is in alignment with the feedback received from the FDA during the guidance meeting held in September 2020. The study showed a clinically meaningful 40% overall response rate.The study will enroll 50 WM patients who have failed first-line therapy and have failed to respond to, or have progressed while on treatment with a BTK inhibitor.Primary endpoint of the trial is response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints

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Cellectar commences pivotal trial of CLR 131 in a rare form bone marrow cancer