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Company Juno Therapeutics second time this year announced the discontinuation of the phase II clinical trial of immunotherapy using JCAR015 cells. The company representatives explained that this is due to the deaths of patients involved in the trials. The study involved people with recurrent B-cell acute lymphoblastic leukemia.
Head Yohans Bishop (Hans Bishop) said that this week from a cerebral edema and died two patients. Previously, the company has suspended clinical trials of anticancer therapy with the use of modified T-lymphocytes (JCAR015 cells). Taken from the patient’s T-lymphocytes are modified, and then administered into the body, where they attack malignant b-cells. In may and June died three participants of the experiment, the cause of their death was also swelling of the brain.
Then the experts suggested that the cause of death of patients was the drug fludarabine, which is used for chemotherapy prior to the introduction of T-cells. Specialists of the company announced that it would renounce the use of fludarabine and replace it with cyclophosphamide. Testing was resumed in August, they took part in 12 patients, two of whom died.
In the near future the leadership of Juno Therapeutics must decide whether these tests continue, or they will have to stop. Bishop noted that for the majority of patients participating in testing, no other suitable methods of treatment – other therapies did not help them.
Therapy JCAR015 cells in General have shown their effectiveness in earlier studies: in 40-90% of patients who have undergone immunotherapy disappeared without any signs of the disease.