On February 2, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported the launch of ResQ215B, a Phase 2 clinical study evaluating a novel chemotherapy-free and lymphodepletion-free combination immunotherapy in patients with indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia.
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The outpatient study evaluates ImmunityBio’s novel, off-the-shelf CD19-targeted high-affinity natural killer (NK) cell therapy (CD19 t-haNK) in combination with nogapendekin-alfa inbakicept (NAI; ANKTIVA), an IL-15 superagonist, and the anti-CD20 monoclonal antibody rituximab. Notably, the regimen does not require any lymphodepleting chemotherapy, distinguishing it from conventional CAR-T cell therapies.
ResQ215B builds on promising results from the Phase 1 QUILT-106 study (NCT06334991), which evaluated CD19 CAR-NK cell therapy in combination with the anti-CD20 rituximab (without ANKTIVA). In that study, durable complete responses were observed in heavily pretreated patients with iNHL, including Waldenström’s Macroglobulinemia.
In an initial chemotherapy-free cohort of patients with Waldenström’s Macroglobulinemia treated with CD19 CAR-NK cells plus rituximab without any lymphodepletion, all four patients achieved clinical disease control. Two patients achieved rapid complete remissions (CR) that remain ongoing at 7 and 15 months of follow-up, respectively, without additional therapy beyond the planned treatment courses. The other two patients achieved stable disease, including one patient with declining IgM levels. These early findings demonstrated a 100% disease control in this small cohort using an outpatient, off-the-shelf CAR-NK cell therapy plus antibody combination without chemotherapy or inpatient hospitalization.
With the addition of ANKTIVA, ResQ215B is designed to evaluate whether further stimulation of innate and adaptive immune responses may enhance the depth and durability of anti-tumor activity. ANKTIVA is designed to promote the proliferation and activation of NK cells and CD8* T cells, potentially augmenting CAR-NK-mediated cytotoxicity and rituximab-driven ADCC.
Preclinical and clinical data suggests that IL-15 agonists may help restore immune function in the face of antibody resistance. In a previously published Phase 1 study (NCT02384954) Foltz et al. reported that combining an IL-15 superagonist with rituximab achieved a 78% complete response rate in patients with relapsed iNHL who had previously failed rituximab therapy.
"Our BioShield platform, which combines cell therapy, our IL-15 superagonist, and a monoclonal antibody in an outpatient, chemotherapy-free setting, represents our vision for Immunotherapy 2.0," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "Building on the durable complete remissions observed with our CD19 CAR-NK cell therapy plus rituximab in Waldenström’s Macroglobulinemia, we are now adding ANKTIVA to further arm the immune system. We believe this off-the-shelf immunotherapy platform can trigger powerful anti-tumor activity without the toxicities of traditional treatments, potentially transforming the treatment paradigm for patients with indolent B-cell malignancies."
"A therapy that does not require apheresis, individualized manufacturing, chemotherapy, or inpatient hospitalization would represent an important advance for patients with iNHL, who are regarded as having incurable lymphomas," said Lennie Sender, M.D., Chief Medical Officer for Cell Therapy and Liquid Tumors at ImmunityBio. "To date, all treated patients have received the therapy in an outpatient setting without significant immune-related toxicities, demonstrating the feasibility of delivering potent cellular therapy without hospital admission. With ResQ215B, we will evaluate whether adding ANKTIVA can further improve response rates and durability while maintaining this favorable safety profile. This could open the door to a more patient-friendly immunotherapy option for follicular lymphoma, Waldenström’s, and other indolent NHL subtypes that currently rely on more aggressive or continuous treatments. Indolent B-cell lymphomas, such as Waldenström’s Macroglobulinemia, remain an area of high unmet medical need."
About the ResQ215B Study
ResQ315B is a Phase 2, open-label study designed to evaluate whether the addition of ANKTIVA can enhance immune-mediated tumor control when combined with CD19 CAR-NK cells and rituximab. The study will enroll adults with CD19⁺/CD20⁺ indolent NHL, including Waldenström’s Macroglobulinemia, who are relapsed or are refractory after at least two prior lines of therapy. Treatment will be administered in 21-day outpatient cycles without preconditioning chemotherapy.
About CD19 t-haNK
ImmunityBio’s CD19 t-haNK is an off-the-shelf, allogeneic NK-92-based cell therapy genetically engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This dual-engineered design enables two complementary mechanisms of action: direct CAR-mediated cytotoxicity against CD19-expressing malignant B cells, and augmented antibody-dependent cellular cytotoxicity (ADCC) when paired with an anti-CD20 antibody such as rituximab. By targeting both CD19 and CD20, the combination is designed to reduce immune escape and improve overall response rates.
(Press release, ImmunityBio, FEB 2, 2026, View Source [SID1234662394])