According to a story from BioPortfolio, Celgene Corporation and bluebird bio, Inc., have recently announced that enrollment for a pivotal Phase 2 study testing an experimental therapy for relapsed/refractory multiple myeloma has been completed. The trial will test bb2121, an investigational, experimental, anti-BCMA CAR-T cell therapy. The therapy is being developed between the two companies are part of a special agreement.
About Multiple Myeloma
Multiple myeloma, which is occasionally referred to as plasma cell myeloma, is a blood cancer that affects plasma cells. These are white blood cells that produce antibodies. The overall cause of multiple myeloma is not well understood, however, some risk factors have been identified. These include obesity, family history, smoldering myeloma, and monoclonal gammopathy of undetermined significance. These last two conditions have the potential to develop into multiple myeloma. Symptoms of this cancer include bone pain, infections, anemia, kidney failure, overly thick blood, confusion, fatigue, headaches, and amyloidosis. Treatment includes chemo, stem cell transplant, and other medications for relapsed disease, which is common. Five year survival rate is 49 percent in the US. To learn more about multiple myeloma, click here.
This Phase 2 clinical trial, known as KarMMa, will test the safety and effectiveness of bb2121 in patients with refractory or relapsed multiple myeloma. While the data on the safety and efficacy of bb2121 has yet to be established, the experimental drug was granted PRIority Medicines (PRIME) eligibility by the European Medicines Agency (EMA) and Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). These designations were based on early Phase 1 clinical data.
About CAR-T Cell Therapy
CAR-T cell therapy is a type of immunotherapy in which T cells, which are white blood cells that play a role in destroying potential threats to the body, are extracted from a patient with cancer. Then, these cells are modified so that they are capable of detecting and recognizing the cells of a tumor as a threat. These modified cells are then propagated and reintroduced into the body of the patient, where they are now capable of killing cancer cells. Therapies of this type have already been approved to treat certain types of cancer.