Idecabtagene vicleucel (ide-cel; previously bb2121) is a cancer immunotherapy candidate that Celgene (now part of Bristol-Myer Squibb) is developing in collaboration with Bluebird Bio to treat people with myeloma.
The companies are seeking approval from the U.S. Food and Drug Administration (FDA) to market ide-cel.
How does ide-cel work?
Ide-cel is a type of immunotherapy called a chimeric antigen receptor (CAR) T-cell therapy.
Researchers make CAR T-cells using a patient’s own T-cells, a type of white blood or immune system cell. They collect a sample of the patient’s white blood cells from a blood sample. Then, they genetically modify the isolated T-cells in the laboratory to recognize specific proteins found on the surface of cancer cells. Finally, they grow these T-cells to very high numbers, and infuse them into the patient.
When researchers reintroduce ide-cel into the patient’s body, it recognizes a protein called B-cell maturation antigen (BCMA), which is present in high numbers on the surface of myeloma cells. Recognition of this disease marker by the modified T-cells triggers an attack on the myeloma cells, targeting them for destruction.
Ide-cel in clinical trials
A Phase 1 clinical trial (NCT02658929) is testing ide-cel in patients with advanced myeloma who received at least three prior treatments for their disease. The study began in January 2016 and enrolled 67 people. It is evaluating the safety and efficacy of ide-cel, potentially following patients for up to five years after treatment. It is expected to finish in November 2023.
Preliminary results indicated acceptable safety and tolerability for the treatment. Seventy-six percent of patients experienced cytokine release syndrome, which is a widespread inflammatory response as a result of the rapid release of immune signals called cytokines. In two patients, this condition was severe. Fourteen others (42% of all patients) had neurological side effects; for one patient, this response was life-threatening but treatable. Fourteen patients also experienced infections, which were severe in two of them.
A long-term follow-up study (NCT02786511) examined patients enrolled in the Phase 1 trial for up to 15 years, further evaluating ide-cel’s long-term safety and effectiveness.
An open-label, Phase 2 trial (NCT03361748), called KarMMa, is assessing the safety and efficacy of ide-cel in patients with relapsed and refractory multiple myeloma who had at least three prior treatment lines, including an immunomodulatory treatment, a proteasome inhibitor, and an anti-CD38 inhibitor, and failed to respond to these regimens. The study is looking at the percentage of patients still responding to ide-cel treatment two years after receiving it, as well as the percentage of patients who achieve a complete response.
Initial data, announced in a press release from Bristol-Myers Squibb, showed that at a median follow-up of 11.3 months, 73.4% of patients had responded to treatment. About 31.3% achieved complete responses over a period of two years. The median duration of response was 10.6 months.
This study is due to conclude in November 2024.
Other information
Ide-cel has been granted a breakthrough therapy designation from the FDA, and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA) due to its potential in treating myeloma.
Last updated: April 16, 2020
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