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RecruitingPhase 2

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.

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 Relapsing Forms of B-cell Dependent Rheumatologic Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AlloNK with rituximab and how well they work together. AlloNK uses donor immune cells from cord blood that have not been genetically changed. The study is for people with hard-to-treat rheumatoid arthritis, Sjögren’s disease, inflammatory muscle disease, or systemic sclerosis.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For rheumatoid arthritis: Meet the 2010 ACR/EULAR diagnosis rules and test positive for RF or ACPA, blood markers linked to this disease. Have an inflammation blood test showing hs-CRP above 3 mg/L or ESR above 28 mm/hr.
  • For rheumatoid arthritis: Have at least 6 swollen and 6 tender joints. Have tried a biologic drug, which targets the immune system, for at least 12 weeks, with your doctor judging that it did not work well enough.
  • For Sjögren’s disease: Have a prior diagnosis of primary Sjögren’s disease under the 2016 ACR/EULAR rules, confirmed within 24 weeks before screening.
  • For Sjögren’s disease: Have a clinESSDAI disease activity score above 6. Make more than 0.1 mL of saliva per minute when saliva flow is stimulated.
  • For inflammatory muscle disease: Test positive for antibodies that can attack your own body: ANA above 1:80, RNP, SSA/SSB, or another antibody linked to muscle inflammation. When needed, have a muscle tissue test or MRI scan confirming the disease within 12 months before joining.
  • For inflammatory muscle disease: Have tried steroids and/or at least one other medicine that lowers immune activity for at least 3 months, without enough benefit or without being able to tolerate treatment.
  • For systemic sclerosis: Meet the 2013 ACR/EULAR diagnosis rules, with the first confirmed diagnosis within 8 years before screening. Have a modified Rodnan skin score, which measures skin thickening, above 10.
  • For systemic sclerosis: Have tried steroids and/or at least one other medicine that lowers immune activity for at least 3 months, without enough benefit or without being able to tolerate treatment.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    For Subjects with Refractory Rheumatoid Arthritis (RA): * 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. * Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment. For subjects with Sjögren's Disease (SjD) * Prior diagnosis of Primary SjD as per 2016 ACR/EULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening. * Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \> 6. * Salivary Flow Rate \> 0.1 mL/min on stimulation. For subjects with Idiopathic Inflammatory Myopathies (IIMs) * Presence of a positive autoantibody (ANA \>1:80 or RNP or SSA/SSB or other myositis specific autoantibodies. * Refractory IIM as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive. * Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment. For Subjects with Systemic Sclerosis (SSc) * Diagnosis of SSc in accordance with the ACR/EULAR 2013 classification. * Modified Rodnan skin score (mRSS) \> 10. * Initial confirmatory diagnosis within 8 years of screening. * Refractory SSc as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.

    Study sites (31)

    AL

    AZ

    CA

    FL

    GA

    IA

    IL

    MT

    NC

    SC

    TN

    TX

    VA