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?

A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.

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+