CAR-NK cell approach achieves ‘efficacy, persistence and super safety’ in lupus
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WASHINGTON — Chimeric antigen receptor nature-killing cell therapy achieved “efficacy, persistence and super safety” in a small cohort of patients with systemic lupus erythematosus, according to data presented at ACR Convergence 2024.
“The unique biological characteristics of NK cells provide us with alternative to treat SLE with super safety,” Qian Hao, PhD, co-founder and CEO of Rui Therapeutics, told attendees.
Hao presented findings from 22 patients — including 18 women — with active severe and refractory SLE who underwent three doses of KN5501 (Rui Therapeutics), an allogenic CD19-targeting CAR-NK cell treatment following preconditioning with cyclophosphamide and fludarabine.
Assessed outcomes included lupus low disease activity state (LLDAS), Systemic Lupus Erythematosus Responder Index (SRI) and the 2021 definition of remission in SLE (DORIS). The researchers followed patients for a median duration of 7 months, with the maximum follow-up at 14 months.
Results at 3 months showed an SRI-4 rate of 81%, an SRI-6 rate of 66.7% and an LLDAS rate of 47.6%, according to the researchers.
At 9 months, SRI-4 and SRI-6 responses were 100%, with 75% of patients achieving LLDAS and half the cohort achieving DORIS response.
“No relapses were observed during the follow-up period,” Hao said.
By 12 months, response rates for all of these outcomes had reached 100%, but data for only one patient are currently available.
Looking deeper into the findings, Hao noted improvements in serology and disease activity. “All measures trend down,” he said.
Safety data indicated no serious incidents of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infections or serious adverse events.
“All 22 patients had low doses of glucocorticoids, less than 10 mg per day, in the final follow-up,” Hao said. “We observed efficacy, persistence and super safety.”
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Sun M. Abstract #L17. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
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