AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

A Phase 1 Study to Evaluate the Efficacy and Safety of AB-101, an Allogeneic Cord Blood- Derived NK-Cell Therapy in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.

This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.

Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.

Study Overview

• Status: Active, not recruiting
• Conditions: SLE; Refractory Systemic Lupus Erythematosus; Lupus Nephritis - WHO Class IV; Lupus Nephritis - WHO Class III
• Intervention / Treatment: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: AB-101; Drug: Obinutuzumab

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Artiva Investigational Site Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Artiva Investigational Site Tucson
  • California
    • San Diego, California, United States, 92121
      • Artiva Investigational Site San Diego
  • Florida
    • Aventura, Florida, United States, 33180
      • Artiva Investigational Site Aventura
    • Plantation, Florida, United States, 33324
      • Artiva Investigational Site Plantation
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Artiva Investigational Site Iowa
  • North Carolina
    • Charlotte, North Carolina, United States, 28625
      • Artiva Investigational Site Charlotte
  • Texas
    • Mesquite, Texas, United States, 75150
      • Artiva Investigational Site Mesquite
    • The Woodlands, Texas, United States, 77382
      • Artiva Investigational Site Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for all subjects (Lupus Nephritis or SLE)

• Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria
• Subjects must have had an inadequate response with at least two prior lines of standard of care (SoC) treatment.

Inclusion Criteria for LN:

• Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)
• Evidence of active disease on renal biopsy.
• All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system

Inclusion Criteria for SLE:

• Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.
• British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.
• Subjects have failed at least two conventional therapies

Exclusion Criteria:

• Known past or current malignancy
• Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
• Subjects with known active viral infections
• Severe active CNS Lupus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1: Dose confirmation of AB-101 as Monotherapy	Drug: Cyclophosphamide; Lymphodepleting chemotherapy; Drug: Fludarabine; Lymphodepleting chemotherapy; Drug: AB-101; NK Cell Therapy
Experimental: Phase 1: Dose confirmation of AB-101 plus Rituximab combination	Drug: Rituximab; Anti-CD20 antibody therapy; Drug: Cyclophosphamide; Lymphodepleting chemotherapy; Drug: Fludarabine; Lymphodepleting chemotherapy; Drug: AB-101; NK Cell Therapy
Experimental: Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination	Drug: Cyclophosphamide; Lymphodepleting chemotherapy; Drug: Fludarabine; Lymphodepleting chemotherapy; Drug: AB-101; NK Cell Therapy; Drug: Obinutuzumab; Anti-CD20 antibody therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events	Incidence, severity and causality of adverse events and serious adverse events	From the time of consent through 104 weeks after initiation of study treatment
AB-101 Clinical Activity	Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus	From the time of first dose through 104 weeks after initiation of study treatment

Collaborators and Investigators

• Sponsor: Artiva Biotherapeutics, Inc.
• Investigators: Study Director: Michael Saddekni, M.D., PgDip, BCMAS, Artiva Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lupus; SLE; Lupus Nephritis; AlloNK
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Nephritis; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Rituximab; Cyclophosphamide; fludarabine; obinutuzumab
• Other Study ID Numbers: AB-101-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: AlloNK is early in clinical development, next steps will be based on the progress of our data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No