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ImmunityBio has initiated ResQ215B, an open-label Phase 2 clinical trial evaluating a chemotherapy-free combination immunotherapy in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including Waldenström’s Macroglobulinemia. The outpatient study is assessing the company’s off-the-shelf CD19-targeted natural killer cell therapy (CD19 t-haNK) in combination with its IL-15 superagonist ANKTIVA and rituximab. Eligible patients must have CD19-positive and CD20-positive disease and have failed at least two prior lines of therapy.
The commercial significance of the program is tied primarily to its delivery model. The regimen eliminates lymphodepleting chemotherapy, apheresis, and individualized cell manufacturing, logistical and cost constraints that continue to limit broader CAR-T adoption. ImmunityBio is positioning the combination as an outpatient, allogeneic cellular therapy approach intended to simplify administration while reducing treatment-related complexity relative to existing cell-based modalities.
ResQ215B also extends the clinical use of ANKTIVA beyond its April 2024 FDA approval in bladder cancer. In the lymphoma setting, the company describes ANKTIVA as a means of enhancing NK cell and CD8 T-cell activity when combined with adoptive NK therapy and anti-CD20 targeting. The Phase 2 study builds on earlier Phase 1 QUILT-106 findings referenced by ImmunityBio, in which CD19-directed CAR-NK cells combined with rituximab achieved disease control in a small cohort of patients with Waldenström’s Macroglobulinemia. The current trial adds ANKTIVA to that backbone to evaluate whether immune stimulation can improve response characteristics in a broader indolent lymphoma population.
The immediate stakeholders include ImmunityBio, treatment centers seeking alternatives to inpatient cell therapy, and patients with limited remaining treatment options. The company has not disclosed timelines for interim analyses, efficacy readouts, or regulatory interactions, leaving clinical performance data as the primary unresolved variable.
You can read our previous interview with Richard Adcock, from December 2024.
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