First SLE patient dosed in CAR T-cell therapy Phase 1 trial

Some sites in US, Europe currently recruiting participants with severe SLE

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The first participant has been treated in a Phase 1 clinical trial testing the CAR T-cell therapy CC-97540 (BMS-986353) in people with severe systemic lupus erythematosus (SLE).

“The opportunity to provide lupus patients with access to this treatment, all while ensuring they receive the highest level of care, is a true testament to the collaboration between the cellular therapy and rheumatology programs,” Neil Kramer, MD, a rheumatologist at New Jersey-based Atlantic Health System and the trial’s principal investigator, said in a press release.

Lupus is a chronic disorder in which the immune system mistakenly starts to attack the body’s own healthy tissues. CC-97540 is a CAR T-cell therapy designed to deplete B-cells, which are a type of immune cell that plays a central role in the autoimmune attack.

Researchers want to enroll about 43 people in the Phase 1 clinical trial (NCT05869955). They are looking for patients with severe SLE who haven’t responded to treatment with glucocorticoids and at least two other standard therapies. All participants in the open-label study will receive CC-97540. S

The study is sponsored Bristol Myers Squibb through its subsidiary Juno Therapeutics. More than 30 sites across the U.S. and Europe are active, with several already recruiting participants. Additional information is available at a study website run by Bristol Myers.

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“We hope to collaboratively unlock novel avenues of care that will redefine the landscape of possibilities for these patients and their families,” said Mohamad Cherry, MD, medical director of Atlantic Health’s cellular therapy program.

CC-97540 works by collecting a patient’s immune T-cells and engineering them with a chimeric antigen receptor, or CAR. In CC-97540, T-cells are equipped with a CAR targeting CD19, a protein found on the surface of B-cells.

The modified T-cells are then infused back into the patient’s body. When the T-cells’ CAR binds to CD19 on the patient’s B-cells, it triggers T-cells to attack and kill B-cells.

The approach has been successful in people with blood cancers whose B-cells have grown out of control, and many companies are exploring whether CAR T-cell therapies can also be used to treat autoimmune diseases like SLE.

“CAR-T therapy continues to lead the field in research, representing a pivotal leap forward in our approach to treating patients, especially those facing complex medical challenges,” Cherry said.