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The FDA grants CMD-003 Fast Track Designation for treatment of EBV-positive R/R Lymphoma and PTLD
On 21st February 2017, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to CMD-003 for patients with R/R Lymphoma and Post-Transplant Lymphoproliferative Disease (PTLD) associated with Epstein Barr Virus (EBV).
Cell Medica’s CMD-003, also known as baltaleucel-T, is a preparation of autologous cytotoxic T-Cells, which have been programmed to target EBV antigens such as EBV Nuclear Antigen (EBVNA), BamHI-A Rightward Frame-1 (BARF1), and Latent Membrane Proteins 1 and 2 (LMP1, LMP2). CMD-003 has the potential to treat and manage a range of EVB associated malignancies such as lymphomas, gastric cancers, and nasopharyngeal carcinoma.
Current, active trials taking place with CMD-003 include the international, open-label, phase II CITADEL trial (NCT01948180), which aims to investigate the efficacy of the immunotherapy in EBV-positive Extranodal NK/T-Cell Lymphoma patients with aggressive disease. The estimated primary completion is December of this year. Moreover, the phase II, open-label, CIVIC trial (NCT02763254) aims to assess the safety and clinical activity of CMD-003 in patients with EBV-positive DLBCL, HL, and PTLD. However, primary results of this trial are not expected to be published until December 2018.
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In your experience, what is the average time to secure a reimbursed CAR T-cell therapy manufacturing slot for patients with DLBCL (from decision to treatment with a CAR T-cell therapy)?