Updated version 2 - Bristol Myers Squibb discloses patient deaths in early-stage cell therapy research

Additional details about the disease were provided in paragraph 7, and additional details about the clinical trial were provided in paragraphs 8 to 11.

Reuters, October 23 - Bristol Myers Squibb (BMY.N) disclosed on Friday that a patient had died during an early-stage clinical trial of its experimental CAR-T cell therapy.

The pharmaceutical company's shares fell 2% in early trading.

The company stated that a patient with highly active relapsing multiple sclerosis (a central nervous system autoimmune disorder) died from septic pneumonia.

The patient was participating in the clinical trial of Bristol Myers Squibb’s experimental cell therapy zolacabtagene autoleucel (abbreviated as zola-cel), which is designed to target CD19—a protein found on certain cells and believed to play a role in autoimmune diseases.

After receiving high-dose chemotherapy, the patient developed septic pneumonia and died the following day—44 days after receiving the CAR-T infusion. The patient had experienced delayed movement symptoms, which did not respond to treatment with corticosteroids or intravenous immunoglobulin.

In September this year, the company stated that, given Novartis NOVN.S had previously halted eight clinical trials of its experimental cell therapy called rap-cel, it decided to voluntarily pause the study of zola-cel out of caution while safety data was reviewed (link).

This early clinical trial by Bristol Myers Squibb enrolled a total of 66 patients, including 30 with highly active relapsing multiple sclerosis, while the rest had progressive multiple sclerosis.

In multiple sclerosis, the immune system attacks the protective myelin sheath covering nerve fibers, disrupting the transmission of information between the brain and other parts of the body.

The company said that most side effects were short-lived and reversible, and overall consistent with previously reported data on zola-cel.

In this study, 42.4% of patients developed cytokine release syndrome, a systemic inflammatory response caused by excessive activation of the immune system.

Five patients developed immune effector cell-associated neurotoxicity syndrome, a neurological disorder caused by inflammation, but symptoms resolved in about two days.

One patient with progressive multiple sclerosis experienced a serious neurotoxicity event, but recovered within four days after treatment.

The company stated that, across all zola-cel studies covering autoimmune diseases—including 190 patients treated in early-stage studies—no other serious side effects were reported.

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