ImmunityBio (NASDAQ:IBRX) announced Monday the launch of ResQ215B, a Phase 2 clinical study evaluating a novel, outpatient immunotherapy combination for patients with indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia.
The trial marks a significant step in the company’s push to replace toxic "conditioning" chemotherapy with off-the-shelf natural killer (NK) cell therapies.
The study evaluates a three-part regimen: ImmunityBio’s CD19-targeted high-affinity NK cells (CD19 t-haNK), the IL-15 superagonist ANKTIVA® (nogapendekin alfa inbakicept), and the standard-of-care antibody rituximab.
Unlike traditional CAR-T therapies, which require high-dose lymphodepleting chemotherapy and inpatient stays, this regimen is administered entirely in an outpatient setting without any prior chemotherapy.
ResQ215B follows a successful Phase 1 signal from the QUILT-106 study.
In that earlier trial, a chemotherapy-free cohort of Waldenström’s patients achieved a 100% disease control rate using only the CAR-NK cells and rituximab.
Notably, two heavily pretreated patients achieved complete remissions that have remained ongoing for 7 and 15 months, respectively, without any further treatment.