AlloNK + Rituximab for Rheumatic Diseases

Recruiting at 20 trial locations

Overseen By Chanel Mansfield Associate Director, Clinical Operations, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Artiva Biotherapeutics, Inc.

Must be taking: Biologic DMARDs

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AlloNK (a type of cell therapy), combined with rituximab, to determine its safety and effectiveness for certain autoimmune diseases. It targets individuals with conditions such as rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, or systemic sclerosis, who have not found success with other treatments. For those with these conditions and limited success from previous treatments, this trial might be suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AlloNK, when combined with rituximab, is generally safe. In a study involving 32 patients with autoimmune diseases, the treatment was well-tolerated. The initial safety results indicated that the combination did not cause any unexpected or serious side effects. This suggests the treatment might be safe for those considering participation in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AlloNK is unique because it combines the power of natural killer (NK) cells with Rituximab to tackle rheumatic diseases in a new way. While most treatments focus on reducing inflammation or suppressing the immune system, AlloNK introduces specially prepared NK cells that can potentially target and destroy problematic cells more precisely. This approach could lead to more effective relief with potentially fewer side effects, giving researchers hope for a significant breakthrough in managing these conditions.

What evidence suggests that AlloNK combined with rituximab could be an effective treatment for rheumatic diseases?

Research has shown that AlloNK, when combined with rituximab, may offer significant benefits for individuals with autoimmune diseases such as rheumatoid arthritis. In one study, 64% of patients with B-cell non-Hodgkin lymphoma, who had undergone multiple prior treatments, responded completely to this combination. This finding suggests that AlloNK can be highly effective when paired with rituximab. It reduces B cells, which often contribute to autoimmune diseases. Although primarily studied in other conditions, the success of this combination suggests potential effectiveness for rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. Early results indicate that AlloNK could lead to better outcomes than current treatments. Participants in this trial will receive the AlloNK and rituximab combination to evaluate its effectiveness in rheumatic diseases. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Saddekni, M.D., PgDip, BCMAS

Principal Investigator

Artiva Therapeutics

Are You a Good Fit for This Trial?

This trial is for people with certain B-cell dependent rheumatologic diseases that haven't improved with other treatments. These include Rheumatoid Arthritis, Sjögren's Syndrome, various forms of Myositis, and Systemic Sclerosis. Participants must have a history of these conditions not responding to standard therapies.

Inclusion Criteria

High-sensitivity C-reactive protein (hs-CRP) > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) > 28 mm/hr.

My rheumatoid arthritis has not improved with treatment.

I was diagnosed with Primary Sjögren's Syndrome within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AlloNK® therapy in combination with Rituximab, following a conditioning regimen

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AlloNK®

Trial Overview The study tests AlloNK®, an allogeneic NK cell therapy from cord blood, combined with Rituximab. It aims to see if this combo is safe and effective in treating relapsing forms of the listed rheumatic diseases.

How Is the Trial Designed?

Group I: AlloNK Experimental Treatment 1 Intervention

AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Who Is Running the Clinical Trial?

Artiva Biotherapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

520+

Citations

1. investors.artivabio.com investors.artivabio.com/News-and-Events/news/news-details/2025/Artiva-Biotherapeutics-Announces-Refractory-Rheumatoid-Arthritis-as-Lead-Indication-Upcoming-Data-Releases-and-Corporate-Update/default.aspx

News Details AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases, including a company ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06991114

Study Details | NCT06991114 | AlloNK®, an Allogeneic ... An open-label Phase 2a study to evaluate the safety and efficacy of AlloNK®, an allogeneic cord blood-derived NK cell therapy, in combination with rituximab in ...

3. jrheum.org jrheum.org/content/52/Suppl_1/235.1

POTENT AND SPECIFIC KILLING OF SLE B CELLS WITH ... AlloNK has the potential to be effective in combination with mAbs to induce deeper B cell depletion and improved efficacy, over the mAbs alone, in SLE and LN.

4. pharmexec.com pharmexec.com/view/translating-allonk-efficacy-across-autoimmune-diseases

Translating AlloNK Efficacy Across Autoimmune Diseases ... demonstrate that results from certain trials will translate to similar efficacy across a range of autoimmune conditions.

5. biospace.com biospace.com/press-releases/artiva-biotherapeutics-announces-longer-term-phase-1-2-data-demonstrating-prolonged-durability-for-allonk-in-combination-with-rituximab-in-patients-with-b-cell-non-hodgkin-lymphoma-at-the-asgct-28th-annual-meeting

Artiva Biotherapeutics Announces Longer-term Phase 1/2 ... 64% (9/14) complete response rate with AlloNK + rituximab in heavily pretreated patients that were naïve to prior CAR-T cell therapy, in line with approved ...

6. biospace.com biospace.com/press-releases/artiva-biotherapeutics-to-host-virtual-event-discussing-initial-safety-and-translational-data-in-up-to-32-patients-with-autoimmune-disease-treated-with-allonk

Artiva Biotherapeutics to Host Virtual Event Discussing ... Initial safety data for 32 patients with autoimmune disease treated with AlloNK + mAb therapy, highlighting a favorable tolerability profile ...

7. quiverquant.com quiverquant.com/news/Artiva+Biotherapeutics+to+Host+Webcast+on+Initial+Safety+and+Translational+Data+for+AlloNK+in+Autoimmune+Disease+Treatment

Artiva Biotherapeutics to Host Webcast on Initial Safety and ... Initial safety data for 32 patients demonstrated a favorable tolerability profile for AlloNK + monoclonal antibody therapy, indicating potential ...

8. trials.arthritis.org trials.arthritis.org/trials/NCT06991114

AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood ... An open-label Phase 2a study to evaluate the safety and efficacy of AlloNK®, an allogeneic cord blood-derived NK cell therapy, in combination with rituximab in ...