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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06265220
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Artiva Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Saddekni, M.D., PgDip, BCMAS
Principal Investigator Affiliation Artiva Biotherapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
Arms & Interventions

Arms

Experimental: Phase 1: Dose confirmation of AB-101 as Monotherapy

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

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

Interventions

Drug: - AB-101

NK Cell Therapy

Drug: - Cyclophosphamide

Lymphodepleting chemotherapy

Drug: - Fludarabine

Lymphodepleting chemotherapy

Drug: - Rituximab

Anti-CD20 antibody therapy

Drug: - Obinutuzumab

Anti-CD20 antibody therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Artiva Clinical Trial Site, Birmingham, Alabama

Status

Recruiting

Address

Artiva Clinical Trial Site

Birmingham, Alabama, 35294

Artiva Clinical Trial Site, Tucson, Arizona

Status

Recruiting

Address

Artiva Clinical Trial Site

Tucson, Arizona, 85724

Artiva Clinical Trial Site, Foster City, California

Status

Recruiting

Address

Artiva Clinical Trial Site

Foster City, California, 75150

Artiva Clinical Trial Site, San Diego, California

Status

Recruiting

Address

Artiva Clinical Trial Site

San Diego, California, 92121

Artiva Clinical Trial Site, Aventura, Florida

Status

Recruiting

Address

Artiva Clinical Trial Site

Aventura, Florida, 33180

Artiva Clinical Trial Site, Plantation, Florida

Status

Recruiting

Address

Artiva Clinical Trial Site

Plantation, Florida, 33324

Artiva Clinical Trial Site, Statesville, North Carolina

Status

Recruiting

Address

Artiva Clinical Trial Site

Statesville, North Carolina, 28625

Artiva Clinical Trial Site, The Woodlands, Texas

Status

Recruiting

Address

Artiva Clinical Trial Site

The Woodlands, Texas, 77382