Health TrialsbyHealthPanel

AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.

ConditionsRefractory Rheumatoid Arthritis (RA)Idiopathic Inflammatory Myopathies (IIMs)Systemic Sclerosis (SSc)Rheumatoid Arthritis (RAIIMMyositisSclerodermaSjogren SyndromeSjogrens Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtiva Biotherapeutics, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria.

Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.

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

Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Allogeneic NK Cells

    Drug

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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: AlloNKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety

Dose Limiting toxicities assessed in a incrementing dose design.

Time frame
From enrollment until the end of treatment at Week 104.

Secondary outcomes

1

Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)

Efficacy

Time frame
Week 52
2

Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)

Efficacy

Time frame
Week 52
3

Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)

Efficacy

Time frame
Week 52
4

Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)

Efficacy

Time frame
Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Artiva Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now