ImmunityBio reports scalable manufacturing of its M-ceNK cell therapy platform and early safety results from the Phase I QUILT-3.076 trial combining M-ceNK cells with ANKTIVA in patients with relapsed or refractory solid tumors.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
ImmunityBio has announced the successful completion of two manufacturing engineering programs, NK2022 and NK2023, establishing a reproducible and scalable leukapheresis-to-manufacturing pathway for its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform. Across the NK2022 and NK2023 manufacturing programs and the Phase I trial QUILT-3.076, a total of 74 participants were enrolled, including healthy volunteers and patients with cancer.
The NK2022 and NK2023 programs evaluated the safety of large-volume, non-mobilized leukapheresis and the reproducibility of NK cell enrichment and cytokine-driven memory programming across both healthy donors and cancer patients. A total of 64 participants successfully completed leukapheresis procedures without procedure-related serious adverse events. The collected cells were subsequently used for manufacturing validation and process development.
Among these participants, 10 cancer patients received their processed NK cell product, with a total of 23 doses administered across treatment cycles. Investigators reported no serious adverse events during treatment. The study also demonstrated that M-ceNK cells could be cryopreserved and reused, supporting repeat dosing strategies.
Immune profiling performed after cell collection showed that NK cells obtained from cancer patients maintained functional activity and phenotype comparable to those derived from healthy donors. These NK cells demonstrated strong cytotoxic activity against multiple tumor types, including breast, Merkel cell, ovarian, chordoma, medulloblastoma, glioblastoma, adenocarcinoma, and lymphoma cell lines.
The manufacturing feasibility data supported the Phase I dose-escalation study QUILT-3.076 evaluating autologous M-ceNK cells in combination with ANKTIVA (nogapendekin alfa inbakicept-pmln) in patients with relapsed or refractory solid tumors.
In this trial, 10 patients received weekly intravenous infusions of M-ceNK cells together with subcutaneous ANKTIVA administered every two weeks. The enrolled patients represented several tumor types, including breast (n=4), colon (n=1), duodenum (n=1), renal (n=1), pancreatic (n=1), rectal (n=1), and osteosarcoma (n=1).
The combination treatment demonstrated a favorable safety profile. Investigators reported no Grade 4 or Grade 5 treatment-related adverse events and no cases of cytokine storm, with all infusions performed in an outpatient setting.
The combination approach is designed to enhance immune activation. ANKTIVA functions as an interleukin-15 (IL-15) superagonist, stimulating natural killer cells and CD8+ T cells and supporting their proliferation and persistence after adoptive cell transfer.
Commenting on the findings, Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, said the results demonstrate that potent NK cell therapies can be manufactured at scale and administered safely. He added that generating billions of NK cells from a single apheresis collection could enable multiple treatment doses and support the long-term vision of creating a large-scale “world bank” of natural killer cells for broader patient access.
Additional translational data supporting the M-ceNK platform were presented at the AACR IO Annual Meeting 2026 by researchers from the National Cancer Institute. In preclinical xenograft models of small cell lung cancer, the combination of M-ceNK cells and ANKTIVA produced statistically significant tumor volume reductions and demonstrated persistence of functional NK cells in vivo.
Researchers also observed increased MHC-Class I expression on residual tumor cells following treatment, suggesting a potential dual mechanism of action: direct NK-cell-mediated tumor killing and possible sensitization of remaining tumor cells to immune checkpoint inhibitors.
Neuroendocrine tumors, including small cell lung cancer, frequently lack MHC-Class I expression, which can limit the effectiveness of T-cell-based immunotherapies. However, this characteristic can make such tumors more susceptible to NK-cell-mediated cytotoxicity. Laboratory studies showed that M-ceNK cells displayed strong cytotoxic activity across multiple neuroendocrine tumor models.
According to ImmunityBio, its manufacturing process can generate up to five billion highly purified NK cells from a single leukapheresis collection within approximately 12 days, potentially yielding multiple therapeutic doses. The company believes this capability could support the development of large-scale NK cell banking strategies to expand access to cell-based immunotherapies.
References
ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from Over 60 Healthy and Cancer Donors, 13 March 2026, ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from Over 60 Healthy and Cancer Donors – ImmunityBio
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.