Date: 2014-09-25
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Celldex Therapeutics (USA - NJ)
Product: CDX-301 (FMS-like tyrosine kinase-3 ligand or Flt3L)
Action
mechanism: CDX-301 (Flt3L) is an hematopoietic cytokine currently in Phase 2 development that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. CDX-301 has demonstrated its capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies.
Disease: mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation
Therapeutic area: Transplantation - Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On September 25, 2014, Celldex Therapeutics announced the initiation of a pilot study of CDX-301 for the mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT). The study will explore the utility of CDX-301, also known as FMS-like tyrosine kinase-3 ligand or Flt3L, alone and in combination with Mozobil® and is supported by preclinical data demonstrating that the combination of CDX-301 and Mozobil increased hematopoietic stem cell mobilization and improved transplantation of mobilized cells. The open-label, pilot study will enroll up to 36 participants, or 18 recipient/donor pairs, ages 18 to 65 across two sequentially enrolled cohorts in approximately 10 clinical trial sites in the United States. Study participants include patients (recipients) with specified hematologic malignancies (AML, ALL, MDS, CML, NHL and CLL) and Human Leukocyte Antigen (HLA) sibling-matched healthy volunteers (donors). The primary objective is to assess the safety and tolerability of CDX-301 when given with or without Mozobil. Secondary endpoints will evaluate the adequacy of the resultant grafts as determined by CD34+ yield, the cellular composition of the resultant grafts, and the safety and effectiveness of the resulting grafts across multiple measures.
