Clinical Trials

Date: 2018-09-26

Type of information: Submission of a clinical trial application

phase: 2

Announcement: submission of a clinical trial application

Company: Cytosen Therapeutics (USA - TX)

Product: CSTD002-NK (adoptive NK cell therapy)

Action mechanism:

• cell therapy/immunotherapy product. CSTD002-NK is a high dose, adoptive haploidentical Natural Killer (NK) cell therapy expanded ex vivo using CytoSen’s patented nanoparticle platform.
• CytoSen’s technology platform is based on the work of Dean Lee, M.D., Ph.D., co-Founder of CytoSen and chair of CytoSen’s Scientific Advisory Board and Director of the Cellular Therapy and Cancer Immunotherapy Program for Nationwide Children’s Hospital’s Division of Hematology/Oncology/BMT and Center for Childhood Cancer and Blood Diseases, and Stefan Ciurea, M.D., Associate Professor, Department of Stem Cell Transplantation, MD Anderson Cancer Center.  

Disease: reduction of relapse in high risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On September 26, 2018, CytoSen Therapeutics announced it has received a favorable response from the FDA to its pre-Investigational New Drug meeting package for the proposed Phase 2 trial of CytoSen’s adoptive NK cell therapy, CSTD002-NK, for the reduction of relapse in high risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT).  The proposed Phase 2 trial is CytoSen’s first clinical study utilizing the nanoparticle technology, which produces highly activated NK cells within a scalable manufacturing platform.
• The FDA agreed that the company’s pre-clinical studies, in combination with results from the clinical trial conducted at The University of Texas MD Anderson Cancer Center adequately support the company’s proposed Phase 2 clinical trial. The FDA also deemed the proposed dose regimen, safety assessment and study endpoints as appropriate, and confirmed that interim results from the clinical study could be considered for a Regenerative Medicine Advanced Therapy (RMAT) designation.
• CSTD002-NK, is now poised to initiate Phase 2 trial enrollment in the U.S. in the first half of 2019 as a best-in-class NK cell therapy for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in HSCT patients.

 

Is general: Yes