Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom

Summary

Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy. Part B (CLOVER-WaM) is a pivotal efficacy study evaluating IV administration of iopofosine I 131 in patients with WM that have received at least two prior lines of therapy.

Timeline

Start

2017-07-26

Primary completion

2026-06-22

Completion

2027-12-22

Outcome

Met primary endpoint

release “initial results from the third cohort of its ongoing Phase 2 CLOVER-1 study of CLR 131 have exceeded its pre-specified performance criteria.” cellectar.com ↗

release “Announced CLR 131 achieved primary efficacy endpoints from its Phase 2 CLOVER-1 study in relapsed/refractory B-cell lymphomas” cellectar.com ↗

release “Positive topline data from the pivotal Clover WaM study for iopofosine I 131 was reported on January 8, achieving the primary endpoint” cellectar.com ↗

release “major Response Rate (MRR) was 58.2%, which exceeded the FDA agreed-upon primary endpoint of 20% MRR” cellectar.com ↗

release “Notably, the primary and secondary endpoints were both achieved in the protocol study population (n=55)” cellectar.com ↗

Drugs

Indications