RECRUITING

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.

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Conditions

Refractory Rheumatoid Arthritis (RA)Idiopathic Inflammatory Myopathies (IIMs)Systemic Sclerosis (SSc)Rheumatoid Arthritis (RAIIMMyositisSclerodermaSjogren SyndromeSjogrens DiseaseRefractory Rheumatoid ArthritisAlloNKIdiopathic Inflammatory MyopathiesSystemic SclerosisSjögren's DiseaseRefractory RACell TherapyAllogeneic NK CellsAllogeneic Cell Therapynon-genetically modifiedrituximabcord blood cellsADCC enhancementoutpatientcommunity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Chanel Mansfield Associate Director, Clinical Operations, MPH
CONTACT
1 858 223 7001
clinicaltrials@artivabio.com

Principal Investigator

Michael Saddekni, M.D., PgDip, BCMAS
STUDY_DIRECTOR
Artiva Therapeutics

Study Locations (Sites)

Artiva Clinical Trial Site
Tucson, Arizona, 85748
United States
Artiva Clinical Trial Site
Aventura, Florida, 33180
United States
Artiva Clinical Trial Site
Plantation, Florida, 33324
United States
Artiva Clinical Trial Site
Willowbrook, Illinois, 60527
United States
Artiva Clinical Trial Site
Charlotte, North Carolina, 28625
United States
Artiva Clinical Trial Site
Arlington, Texas, 76012
United States
Artiva Clinical Trial Site
Houston, Texas, 83506
United States

Collaborators and Investigators

Sponsor: Artiva Biotherapeutics, Inc.

  • Michael Saddekni, M.D., PgDip, BCMAS, STUDY_DIRECTOR, Artiva Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2029-01

Study Record Updates

Study Start Date2025-05
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • Refractory Rheumatoid Arthritis
  • AlloNK
  • Idiopathic Inflammatory Myopathies
  • Systemic Sclerosis
  • Sjögren's Disease
  • Refractory RA
  • Cell Therapy
  • Allogeneic NK Cells
  • Allogeneic Cell Therapy
  • non-genetically modified
  • rituximab
  • cord blood cells
  • ADCC enhancement
  • outpatient
  • community

Additional Relevant MeSH Terms

  • Refractory Rheumatoid Arthritis (RA)
  • Idiopathic Inflammatory Myopathies (IIMs)
  • Systemic Sclerosis (SSc)
  • Rheumatoid Arthritis (RA
  • IIM
  • Myositis
  • Scleroderma
  • Sjogren Syndrome
  • Sjogrens Disease