Artiva Biotherapeutics has announced encouraging longer-term data from its ongoing Phase 1/2 clinical trial evaluating AlloNK, an off-the-shelf NK cell therapy, in combination with rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
The updated results demonstrate prolonged durability of response among treated patients, with continued favorable safety profiles that support further development of this novel cellular immunotherapy approach.
"These longer-term data reinforce our confidence in AlloNK's potential to provide meaningful clinical benefit for patients with limited treatment options," said Dr. Fred Aslan, CEO of Artiva Biotherapeutics. "The durability we're observing is particularly encouraging as we advance our clinical development program."
Clinical Trial Design and Patient Population
The open-label, multi-center Phase 1/2 study enrolled patients with relapsed or refractory CD20+ B-cell NHL who had received at least two prior lines of therapy. Participants received AlloNK cells in combination with rituximab, a well-established anti-CD20 monoclonal antibody widely used in lymphoma treatment.
The trial evaluated multiple dose levels of AlloNK cells to determine safety, tolerability, and preliminary efficacy signals. Patients were closely monitored for adverse events, clinical responses, and biomarkers of NK cell activity.
Key Efficacy Findings
The updated analysis showed that patients who achieved an objective response maintained their clinical benefit for significantly longer periods than initially reported. Among responders, the median duration of response has not yet been reached, with several patients maintaining their responses beyond 12 months.
The objective response rate remained consistent with earlier reports, with complete responses observed across multiple dose cohorts. Importantly, responses were seen in patients who had previously progressed on or after anti-CD20 therapy, suggesting AlloNK may help overcome resistance mechanisms.
"What's particularly notable about these results is the depth and durability of responses in a heavily pretreated patient population," commented Dr. Michael Bishop, a principal investigator on the study and lymphoma specialist at the University of Chicago. "The combination of AlloNK with rituximab appears to enhance antibody-dependent cellular cytotoxicity, potentially explaining the robust clinical activity we're observing."
Safety Profile
The longer-term follow-up data continue to demonstrate a favorable safety profile for AlloNK. No dose-limiting toxicities or cases of cytokine release syndrome, neurotoxicity, or graft-versus-host disease were reported—complications that have been associated with other cellular immunotherapies.
The most common treatment-related adverse events were mild to moderate infusion reactions and cytopenia, which were generally manageable with standard supportive care. No new safety signals emerged with extended follow-up.
Advantages of AlloNK Platform
AlloNK represents a significant advancement in cellular immunotherapy as an allogeneic, off-the-shelf product derived from healthy donor NK cells. Unlike autologous CAR-T cell therapies that require individual manufacturing for each patient, AlloNK can be produced at scale and stored for immediate use when patients need treatment.
This approach eliminates the manufacturing delays associated with autologous therapies and potentially makes cellular immunotherapy accessible to more patients. Additionally, NK cells' inherent biology may offer safety advantages over T cell-based approaches.
"The AlloNK platform addresses several key limitations of current cellular immunotherapies," explained Dr. Aslan. "Our manufacturing process yields a highly pure, potent NK cell product that can be administered without the need for toxic lymphodepletion, which is a significant advantage for patients."
Future Directions
Based on these promising results, Artiva plans to advance AlloNK into later-stage clinical trials. The company is also exploring additional combination strategies, including with other monoclonal antibodies and novel agents that may further enhance NK cell activity.
Artiva is additionally investigating AlloNK in other CD20-positive malignancies and exploring the potential of their platform in solid tumors, where effective cellular immunotherapies have proven more challenging to develop.
The company expects to present more detailed data from this trial at upcoming scientific conferences and initiate registration-enabling studies in the near future.
Disease Burden and Unmet Need
Non-Hodgkin lymphoma represents a diverse group of blood cancers with approximately 80,000 new cases diagnosed annually in the United States. Despite advances in treatment, including chemotherapy, immunotherapy, and targeted agents, many patients with aggressive forms of NHL experience relapse or develop refractory disease.
For these patients, prognosis remains poor, with limited effective treatment options. While CAR-T cell therapy has shown promise in certain NHL subtypes, challenges including manufacturing complexity, severe toxicities, and accessibility have limited its broader application.
AlloNK's emerging profile suggests it could potentially address these challenges while providing effective disease control for patients with limited options.
"There remains a significant unmet need for novel therapies that can offer durable responses without prohibitive toxicity for relapsed and refractory lymphoma patients," said Dr. Bishop. "These longer-term data suggest AlloNK may represent an important addition to our therapeutic arsenal."
