Biotechnology company Cellectar Biosciences has started a Phase II clinical trial of CLR 131 for the treatment of patients with hematologic malignancies such as multiple myeloma (MM).
CLR 131 is an investigational phospholipid drug conjugate (PDC) designed to directly deliver a cytotoxic radioisotope known as iodine-131 to tumour cells by using the firm's patented PDC tumour targeting delivery platform.
To be conducted in approximately 15 centres in the US, the Phase II trial will include patients with various orphan-designated relapse or refractory hematologic cancers.
Cellectar Biosciences president and chief executive officer Jim Caruso said: "The prospect of extending patient survival with a one or two-dose treatment continues to drive a high sense of urgency for all involved in this study as we continue to focus on providing clinical benefit to patients who suffer from these difficult-to-treat conditions.
"Given the results from our Phase I trial of CLR 131 in multiple myeloma, we are enthusiastic about the potential outcomes of this Phase II trial, and look forward to reporting results as they become available.”
The trial will enrol subjects with MM, chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL / SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL) and potentially diffuse large B-cell lymphoma (DLBCL).
The primary endpoint of the trial is objective response rate (ORR), while the secondary endpoints include progression-free survival (PFS), median overall survival (OS) and other efficacy markers.
National Cancer Institute intends to provide Cellectar with around $2m in a non-dilutive grant for the Phase II trial.
It is expected that the trial's initial efficacy data will be reported in the second half of this year.