Science
B-cell Reset™: Deep B-cell Depletion, Healthier B-cell Reconstitution
Deep B-cell Depletion
Deep B-cell depletion is a validated treatment strategy in autoimmune disease. When B-cell depletion is incomplete, residual autoreactive B cells may continue to drive disease through autoantibody production, inflammatory signaling and activation of other immune cells. AlloNK is being developed to achieve deep B-cell depletion safely, reproducibly and practically at scale.
Antibody-Directed B-cell Killing
Instead of engineering T cells to target B cells, or redirecting a patient’s endogenous T cells, AlloNK can be used in combination with approved monoclonal antibodies like rituximab, to target and kill B cells. This interaction is called antibody-dependent cellular cytotoxicity, or ADCC. Anti-CD20 antibodies like rituximab provide a well-established mechanism for targeting B cells and have been used for years in autoimmune disease. However, because activity relies in part on a patient’s endogenous NK cells for ADCC, it may not achieve the depth or consistency of B-cell depletion needed to drive durable clinical benefit in patients with autoimmune disease. Studies have shown that patients with autoimmune diseases can have fewer NK cells, and the NK cells that are present can be dysfunctional. AlloNK enhances ADCC, extending depletion beyond what antibody therapy alone can achieve.
How AlloNK® + Rituximab Drives Deeper Depletion than Rituximab Alone
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Pairing rituximab with highly active allogeneic NK cells harnesses the innate cytotoxic machinery of NK cells to amplify the activity of an established antibody. Rituximab binds to CD20 on B cells, while the high-affinity CD16 receptor on AlloNK recognizes the Fc portion of the bound antibody and enables NK cell-mediated killing of the targeted cells. This approach is designed to deliver greater B-cell killing activity and drive deeper, more consistent depletion.
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The Goal: B-cell Reset™
In data presented at EULAR 2026, uniform and consistent peripheral B-cell depletion was observed by Day 13 in 51 evaluable patients with autoimmune disease following treatment with cyclophosphamide and fludarabine conditioning, AlloNK and rituximab. Complete B-cell depletion was observed using a high-sensitivity assay in 28 evaluable patients with refractory rheumatoid arthritis as of April 3, 2026.
Following treatment with AlloNK plus rituximab, B-cell reconstitution in evaluable patients was characterized by a predominance of naïve and transitional B cells, a pattern consistent with the proposed B-cell Reset™ mechanism. Longer follow-up is needed to determine how this pattern of reconstitution relates to the durability of clinical response.
Achieving a B-cell Reset Without the Side Effects of T cell Approaches
Unlike CAR T and T-cell engager approaches that can cause cytokine release syndrome (CRS) in patients due to T-cell activation and expansion, AlloNK does not rely on T cells for its activity. As of April 3, 2026, no CRS or ICANS was observed in the autoimmune safety dataset with over 50 patients, supporting continued development in outpatient and community rheumatology settings.
AlloNK® Manufacturing
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Manufacturing for Use in Outpatient Rheumatology Settings
Large autoimmune disease populations require a product that can be manufactured consistently, distributed reliably and available when a patient is ready for treatment. Artiva manufactures AlloNK as a cryopreserved, off-the-shelf product, without requiring patient-specific cell collection or manufacturing.
Starting with Selected Donor Cells
Artiva sources healthy donor cord blood from established cord blood banks and pre-selects units for characteristics associated with NK cell activity, including the high-affinity CD16 158V/V variant and KIR-B haplotype. By selecting for these characteristics in donor material, Artiva can generate a non-genetically modified NK cell product with consistent functional attributes.
A Two-Stage Expansion Process
NK cells are isolated from the selected cord blood unit and expanded using Artiva’s proprietary manufacturing process, then purified and cryopreserved to create a cryopreserved intermediate cell bank (ICB). A single selected cord blood unit can generate approximately 50 to 80 ICB units.
Each ICB unit can then be expanded to produce approximately 80 to more than 100 one-billion-cell AlloNK drug product vials. The drug product is vialed using an infusion-ready media and cryopreserved for long-term storage, distribution and infusion at clinical sites.
Clinical-Stage Manufacturing at Scale
Artiva and GC Cell have produced more than 50 clinical batches and thousands of one-billion-cell AlloNK vials, demonstrating batch-to-batch and donor-to-donor consistency.
Artiva’s San Diego headquarters includes a 9,000-square-foot, multi-suite, Good Manufacturing Practice cell production center. At the current 50-liter scale, our facility has the potential to treat over 500 patients annually.
From Manufacturing Facility to Infusion Chair
Reaching the large populations of patients with autoimmune diseases will require bringing deep B-cell depletion beyond specialized treatment centers and into the settings where patients already receive care.
Because AlloNK is off-the-shelf, clinical sites do not need to collect a patient’s cells or wait for an individualized product to be manufactured. The product format supports predictable scheduling, broad distribution and repeat dosing if needed.
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Publications and Presentations
- AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy, Combined with Rituximab Generates Robust Efficacy Responses in 11 Patients with Sjögren Disease
- High affinity CD16v/v allogeneic NK cell therapy, AB-101, enhances antibody-mediated cytotoxicity in B-cell driven diseases. Cytotherapy. 2026.
- AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy, Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases.
- AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated.
- Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies.
- AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases.
- Treatment with an Allogeneic NK Cell Therapy, AB-101, in Combination with Anti-CD20 Antibodies in Immune-mediated Diseases Demonstrates a Favorable Safety Profile and Comparable B-cell Depletion to CD19 CAR T Therapies.
- AlloNK® Cell Therapy Is More Cost-Effective than CAR T Treatments for Rheumatologic Diseases.
- AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma.
- AlloNK®: A Scalable and Consistent NK Cell Therapy in Development for Treatment of Oncology and Autoimmune Diseases.
- AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma.
- AB-101, an Allogeneic, Non-Genetically Modified, Natural Killer (NK) Cell Therapy, Evaluated as Monotherapy or in Combination with Rituximab in R/R Non-Hodgkin Lymphoma.
- AFM13 Enhances the Anti-Tumor Activity of AB-101 Towards CD30+ Tumors, Conferring Tumor Growth Control In Vivo.
- Combinatorial Immunotherapy of Tetravalent Bispecific AFM13 and AB-101 NK Cell Product Confers Tumor Growth Control In Vivo.
- Evaluation of AB-101, an Allogeneic Cord Blood-Derived Natural Killer (NK) Cell Therapy, as an ADCC Enhancer in Hematologic and Solid Tumors.
- Pre-Clinical Efficacy of AB-101, an Allogeneic Cord Blood-Derived Natural Killer (NK) Cell Therapeutic Candidate, in Combination with Anti-CD38 Antibodies in Models of Multiple Myeloma.
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AlloNK is an investigational therapy and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
The clinical data for AlloNK are based on separate studies and include data from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial. No head-to-head trial has evaluated AlloNK against the other therapies discussed on this website. Differences in trial design, patient populations and product candidates limit cross-trial comparisons.