ImmunityBio has reported ongoing complete responses of up to 15 months in two recipients of its CAR-NK cell therapy, leading the biopharma to talk up the prospects of the off-the-shelf blood cancer treatment.
Patients in the phase 1 trial are receiving ImmunityBio’s CD19 CAR-NK cell therapy in combination with anti-CD20 antibody rituximab. Last year, the company reported complete responses in two patients with Waldenstrom macroglobulinemia, a type of non-Hodgkin lymphoma. At the time, one of the complete responses had lasted six months.
Friday, ImmunityBio said the two complete responses are ongoing after seven and 15 months. The patients received four cycles of CD19 CAR-NK plus rituximab, with no further treatment thereafter. Current standards of care failed both patients, who had extensive disease at baseline.
Complete remissions occurred after two treatment cycles. Doctors administered the treatments in outpatient settings without the chemotherapy and lymphodepletion regimens required for some other cell therapies.
“To date, all patients have been treated as outpatients with no serious adverse events, demonstrating the feasibility of delivering potent cellular immunotherapy without the morbidity traditionally associated with cell-based treatments,” Lennie Sender, M.D., chief medical officer, liquid tumors and cell therapy at ImmunityBio, said in a statement.
The biopharma is continuing to enroll patients in the rituximab-combination study while preparing to start a follow-up trial. The next study will assess the CAR-NK cell therapy in combination with rituximab and Anktiva, an IL-15 agonist designed to activate natural killer cells.
The FDA approved ImmunityBio’s Anktiva for bladder cancer in 2024, with the company reporting preliminary net product revenue of $38.3 million for the fourth quarter of 2025.
While sales of Anktiva are growing, ImmunityBio’s promotion of the drug has prompted a warning from the FDA, after the agency took issue with the efficacy statistics quoted by the biopharma.