CMD-003 is an investigational immunotherapy being developed by Cell Medica to treat cancers that are associated with the Epstein-Barr virus (EBV), including Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphomas (NHL).
How CMD-003 works
EBV infections can cause short-term illness, but the virus also can hide in the body for a long time without causing any symptoms. Silent EBV infection plays a role in the development of some cancers, particularly cancers that affect white blood cells, such as lymphomas.
It is a type of immunotherapy that uses a patients’ own T-cells to fight EBV-infected cancer cells. The CMD-003 T-cells are made by harvesting T-cells from a blood sample. These T-cells are then modified in the laboratory to recognize specific proteins found in cells with EBV. The modified T-cells, called CMD-003 T-cells, are infused back into the patient’s bloodstream to seek out and destroy EBV-infected tumor cells.
CMD-003 in clinical trials
Two clinical trials testing CMD-003 in patients with EBV-positive lymphoma are in progress.
CITADEL (NCT01948180) is a Phase 2 single-arm trial of CMD-003 in patients with aggressive extranodal natural killer cell/T-cell lymphoma, a rare type of NHL.
The study, sponsored by Cell Medica aims to enroll about 35 participants, who will receive at least two infusions of CMD-003. The goal is to see how well CMD-003 works to fight the cancer and how safe the therapy is. Patients who are responding well to the first two infusions may have up to three additional infusions.
The trial began in September 2014, has an estimated completion date of September 2019, and is still recruiting participants.
CIVIC (NCT02763254), also a Phase 2 study sponsored by Cell Medica, will find out how safe and effective CMD-003 therapy is in patients with HL, diffuse large B-cell lymphoma (a subtype of NHL), and post-transplant lymphoproliferative disorder (PTLD) who have not responded to a previous treatment.
CIVIC, which began in November 2015, will include about 70 patients and also is still recruiting participants.
Additional information
In February 2017, it received fast-track designation from the U.S. Food and Drug Administration (FDA), which speeds the development of drugs for conditions that have few treatment options. CMD-003 already had been granted orphan drug status, which is reserved for drugs being developed for very rare conditions.
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