Cellectar Biosciences has recruited the first patient with diffuse large B-cell lymphoma (DLBCL) into its Phase 2 clinical trial testing the company’s lead investigational phospholipid-drug conjugate, CLR 131.
The trial includes five cohorts of patients with different relapsed or refractory B-cell cancers – multiple myeloma; chronic lymphocytic leukemia/small lymphocytic lymphoma; lymphoplasmacytic lymphoma; marginal zone lymphoma; mantle cell lymphoma; and DLBCL.
DLBCL patients are eligible for enrollment if they have relapsed or failed to respond to combined chemotherapy with Rituxan (rituximab) and an anthracycline.
Cellectar expects to enroll 10 patients in the DLBCL group and, after enrollment is finished, they can start an interim analysis, before data collection has been completed. If the interim analysis is positive, the DLBCL patients could expand and integrate an additional 10 to 20 patients.
The Phase 2 trial (NCT02952508) is an open-label study ongoing in 10 leading cancer centers in the United States. The study’s primary endpoint is to determine clinical benefit response – the proportion of patients achieving at least disease stabilization – after a single injection of CLR 131 (delivered at 25.0 mCi/m2 dose) with the possibility of a second injection of equal dose 75 to 180 days later.
Secondary endpoints include the time to disease progression or death, and median overall survival, among others.
Patients with multiple myeloma will also receive 40 mg oral dexamethasone weekly for up to 12 weeks.
“DLBCL is a rare hematologic cancer with few treatment options and the expansion of the Phase 2 trial provides the opportunity to further explore the broad treatment potential of CLR 131 in an area of significant unmet need,” James Caruso, president and CEO of Cellectar Biosciences, said in a press release.
“We are now exploring CLR 131 in six hematologic malignancies and we expect to initiate Phase 1 studies in head and neck cancer and pediatric tumors in 2018,” Caruso said.
“Importantly, we are able to undertake our development plans with modest shareholder investment as our Phase 2 study is partially funded through a National Cancer Institute (NCI) Small Business Innovation Research grant,” he added.
CLR 131 is an investigational phospholipid drug conjugate (PDC), a cancer therapy that explores the tumor-targeting properties of phospholipid molecules to selectively deliver radiation to malignant tumor cells.
The medicine uses the PDC tumor-targeting delivery platform to deliver a toxic radioisotope, iodine-131, directly to tumor cells. This mechanism of action was developed to minimize radiation exposure to normal tissues.