Immunotherapies stimulate the body’s natural defenses to fight cancer.
How bb2121 works
bb2121 is a type of immunotherapy called a chimeric antigen receptor (CAR) T-cell therapy.
CAR T-cells are made from the patient’s own T-cells, a type of white blood cell in the immune system. A sample of the patient’s white blood cells is collected, and T-cells are genetically modified in the laboratory to recognize specific proteins found on the surface of cancer cells. T-cells are then grown to very high numbers and reintroduced into the patient’s body.
When reintroduced into the patient’s body, bb2121 recognizes a protein called B-cell maturation antigen (BCMA), which is present on the surface of multiple myeloma cells, binds to it and kills tumor cells.
bb2121 in clinical trials
bb2121 is being studied in a Phase 1 clinical trial (NCT02658929) in patients with multiple myeloma who received at least three prior treatments for their disease. The study began in January 2016 and is recruiting a total of 50 participants at seven sites in the U.S.
The first pre-clinical data in mouse models of human multiple myeloma and Burkitt lymphoma for bb2121 were presented in December 2015 at the 57th American Society of Hematology Annual Meeting. The results showed that a single administration of bb2121 produced a rapid and sustained elimination of tumors with 100 percent survival, and supported the clinical development of bb2121.
The first clinical data for bb2121 were presented at the 28th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, in December 2016. The results showed that bb2121 had promising effectiveness, with two complete responses and ongoing clinical responses at six months of treatment.
Updated results from this study were presented at the 2017 annual European Hematology Association (EHA) Congress. They showed that all nine patients treated with bb2121 responded to treatment with 27 percent of patients achieving a complete response, and 75 percent had a partial response or better. All the responses lasted for up to 54 weeks. No significant toxicities or safety concerns related to the treatment were noted.
Another study (NCT02786511) is following patients who were treated with bb2121 in the previous Phase 1 trial for up to 15 years, to evaluate the long-term safety and effectiveness of bb2121 treatment. This study started in May 2016 at the same sites as the parent Phase 1 trial and is enrolling participants by invitation only.
In a November 2017 press release, Celgene announced that bb2121 received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA), and also was considered as a candidate for PRIority MEdicines (PRIME) status by the European Medicines Agency (EMA), due to its potential as a novel treatment for multiple myeloma.
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