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

NCT06265220 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AB-101-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Lupus Nephritis - WHO Class III; Lupus Nephritis - WHO Class IV; Refractory Systemic Lupus Erythematosus; SLE

Keywords

SLE; Lupus; Lupus Nephritis; AlloNK

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Phase 1: Dose confirmation of AB-101 as Monotherapy

EXPERIMENTAL

Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine

Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination

EXPERIMENTAL

Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Obinutuzumab

Phase 1: Dose confirmation of AB-101 plus Rituximab combination

EXPERIMENTAL

Drug: AB-101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab

Interventions

AB-101 DRUG

NK Cell Therapy

Phase 1: Dose confirmation of AB-101 as Monotherapy; Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination; Phase 1: Dose confirmation of AB-101 plus Rituximab combination

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1: Dose confirmation of AB-101 as Monotherapy; Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination; Phase 1: Dose confirmation of AB-101 plus Rituximab combination

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1: Dose confirmation of AB-101 as Monotherapy; Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination; Phase 1: Dose confirmation of AB-101 plus Rituximab combination

Rituximab DRUG

Anti-CD20 antibody therapy

Phase 1: Dose confirmation of AB-101 plus Rituximab combination

Obinutuzumab DRUG

Anti-CD20 antibody therapy

Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artiva Biotherapeutics, Inc.: lead

Study Sites (9)

Artiva Investigational Site Birmingham

Birmingham, Alabama, 35249, United States

Location

Artiva Investigational Site Tucson

Tucson, Arizona, 85724, United States

Location

Artiva Investigational Site San Diego

San Diego, California, 92121, United States

Location

Artiva Investigational Site Aventura

Aventura, Florida, 33180, United States

Location

Artiva Investigational Site Plantation

Plantation, Florida, 33324, United States

Location

Artiva Investigational Site Iowa

Iowa City, Iowa, 52242, United States

Location

Artiva Investigational Site Charlotte

Charlotte, North Carolina, 28625, United States

Location

Artiva Investigational Site Mesquite

Mesquite, Texas, 75150, United States

Location

Artiva Investigational Site Woodlands

The Woodlands, Texas, 77382, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Interventions

Cyclophosphamide; fludarabine; Rituximab; obinutuzumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael Saddekni, M.D., PgDip, BCMAS

  Artiva Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)