Culver City, Calif. – ImmunityBio, a commercial-stage immunotherapy company, announced today the successful completion of manufacturing engineering programs, NK2022 and NK2023, establishing a scalable process for producing its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform. The company has now validated the ability to produce and cryopreserve NK cells from over 60 healthy donors and cancer patients, a milestone hailed as a significant step toward establishing a “World Bank of NK Cells.”
The manufacturing process yields up to 5 billion highly pure activated memory cytokine-enhanced NK cells (M-ceNK) from a single apheresis, providing between 8 and 10 doses per patient. ImmunityBio has established a process allowing for finished dosage forms of M-ceNK cells to be available within 12 days of apheresis and has successfully cryopreserved these cells while maintaining their cytotoxicity against multiple tumor cell lines.
This achievement positions ImmunityBio to utilize AI-driven automated robotic systems, specifically NANT Leonardo, for manufacturing. The company also reported the completion of a Phase 1 safety study (QUILT 3.076) combining M-ceNK with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with relapsed or refractory tumors, demonstrating safety following infusion of the M-ceNK product. The Phase 1 trial enrolled 10 patients, according to Investing.com.
In a separate development, ImmunityBio launched a Phase 2 clinical study on February 2, 2026, evaluating a chemotherapy-free combination immunotherapy for patients with indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia. This study, ResQ215B, combines ImmunityBio’s CD19 t-haNK – an off-the-shelf CAR-NK cell therapy – with ANKTIVA® and rituximab. The regimen notably excludes lymphodepleting chemotherapy, differentiating it from conventional CAR-T cell therapies. Phase 1 data for this approach demonstrated durable complete responses when CAR-NK cell therapy was administered with rituximab, without chemotherapy or ANKTIVA.
The CD19 t-haNK cell therapy is designed to directly kill tumor cells and enhance antibody-dependent cellular cytotoxicity (ADCC) when combined with the anti-CD20 antibody rituximab. The addition of ANKTIVA aims to further boost NK and T-cell activity and potentially overcome tumor resistance to rituximab, improving treatment outcomes in indolent lymphomas.
