CMD-003 (baltaleucel-T) is a cell-based immunotherapy being investigated as a treatment for Epstein-Barr virus (EBV)-positive cancers and particularly Hodgkin’s lymphoma (HL), non-Hodgkin’s lymphoma (NHL), and nasopharyngeal carcinoma (NPC).
How CMD-003 works
About 9 in 10 people worldwide have been infected with EBV sometime in their lives. The virus usually infects a type of immune cell, called B-cells. The initial infection may cause glandular fever, but once this has passed it tends to cause few or no symptoms, but the virus remains in the body.
A small proportion of infected individuals may go on to developing cancer in the EBV-infected cells. EBV can produce proteins that contribute to the survival of the cancer cells and help them hide from the immune system.
Using its T-cellerator technology, Cell Medica has developed CMD-003 as a treatment to specifically target EBV-infected cells. CMD-003 is made of the body’s own T-cells, a type of immune cell that can track down and destroy abnormal and infected cells, which are activated to target the EBV-infected cells.
The T-cells are first isolated from a blood sample taken from the patient. The population of T-cells is activated to recognize and fight EBV, via stimulation by dendritic cells presenting EBV antigens (proteins produced by the EBV). The role of dendritic cells in the body is to train T-cells to recognize an infection by taking a protein produced as part of the infection and directing the T-cell to hunt it down.
The population of EBV-specific T-cells is then increased in size and cryopreserved, or frozen, ready to be administered to the patient. Once in the patient’s body, CMD-003 exerts its anti-tumor activity by targeting and binding to cancer cells, destroying them.
CMD-003 in clinical trials
Cell Medica is currently engaged in two clinical trials for CMD-003, both sponsored by Cell Medica and both investigating the drug as a lymphoma therapy.
The first trial, CITADEL (NCT01948180), is a Phase 2 open-label, single-arm study testing CMD-003 as a therapy for EBV-positive extranodal NK/T-Cell lymphoma (ENKTCL), a type of NHL. The study, which is currently recruiting participants, aims to enroll 35 patients who will receive two intravenous infusions of CMD-003 at days 1 and 15 of the study. Patients will be monitored for up to two years to assess the safety and effectiveness of the treatment.
The second trial, (NCT02763254), will investigate CMD-003 as a therapy for EBV-positive HL, diffuse large B-cell lymphoma (DLBCL, a type of NHL) and PTLD. The open-label, single-arm Phase 2 study intends to enroll 70 patients who will receive up to five intravenous infusions of CMD-003 every two weeks. Patients will be monitored for up to two years for adverse effects, and the effectiveness of CMD-003 will be assessed through multiple measures, including the overall response, duration of response, progression-free survival, and overall survival.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted CMD-003 orphan drug status.
In March 2015, the FDA granted CMD-003 orphan drug designation for the treatment of EBV-positive NHL, and in February 2017, the drug was granted fast track designation by the FDA to help facilitate its development as a lymphoma and PTLD treatment.
The EMA granted CMD-003 orphan drug status for the treatment of ENKTCL, NPC, and PTLD in July 2016.
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