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.
By adding ANKTIVA to this "chemo-free" cocktail, ImmunityBio aims to further boost the activation of the patient's innate and adaptive immune systems.
"A therapy that does not require individualized manufacturing, chemotherapy, or inpatient hospitalization would represent an important advance for patients with iNHL," said Lennie Sender, M.D., Chief Medical Officer for Liquid Tumors at ImmunityBio.
The news comes as ImmunityBio shares have surged over 215% year-to-date, fueled by expanding clinical data across its platform.
The company, which recently received a Warning Letter from the FDA regarding certain ANKTIVA marketing claims, is doubling down on clinical validation to solidify its position in the $20 billion hematological malignancy market.