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Cellectar Reports 94% Reduction in Overall Tumor Volume in Waldenstrom Macroglobulinemia Patient in Phase 2 CLR 131 Clinical Study
Prior to study enrollment, this 67-year-old female patient was diagnosed with Waldenstrom macroglobulinemia and had received two lines of multi-drug therapy with the most recent treatment achieving a best response of disease progression. As part of Cellectar’s Phase 2 study in hematologic cancers, the patient received a single 25mCi/m2 dose of CLR 131 over a 30-minute infusion period. On day 52 post infusion, a CT scan showed a >50% reduction in tumor volume and was classified as a partial response.
Based on this initial response and additional clinical factors, the treating physician,
“In addition to a robust clinical response, we were also happy to see resolution of symptoms that affected the patient’s quality of life, including shortness of breath associated with moderately-sized pleural effusion shortly after the patient’s first dose of CLR 131,” stated Dr. Ailawadhi. “CLR 131 has shown good clinical response in LPL as well as other hematologic indications and could provide an excellent addition to the treatment armamentarium.”
About Waldenstrom Macroglobulinemia
Waldenstrom macroglobulinemia is a rare type of cancer that begins in the white blood cells, according to the
About the Phase 2 Study of CLR 131
The Phase 2 study is being conducted in approximately 10 leading cancer centers in
The study's primary endpoint is clinical benefit response (CBR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later.
In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest
About CLR 131
CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company's proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.
The company's lead PDC therapeutic, CLR 131, is in a Phase 1 clinical study in patients with relapsed or refractory (R/R) MM and a Phase 2 clinical study in R/R MM and a range of B-cell malignancies. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer. The company’s product pipeline also includes two preclinical PDC chemotherapeutic programs (CLR 1700 and 1900) and partnered assets include PDCs from multiple R&D collaborations.
For more information please visit www.cellectar.com.
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Source: Cellectar Biosciences, Inc.