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Immune cell therapy shows promise for tough lupus cases

NCT ID NCT06265220

Disease control Sponsor: Artiva Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new treatment called AB-101 for people with lupus nephritis or other hard-to-treat lupus. AB-101 uses donated natural killer cells to boost the body's ability to fight the disease. The study aims to see if this approach is safe and can help patients who have not responded to standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis - who class III Lupus nephritis - who class IV Refractory systemic lupus erythematosus SLE

Contacts and locations

Locations

  • Artiva Investigational Site Aventura

    Aventura, Florida, 33180, United States

  • Artiva Investigational Site Birmingham

    Birmingham, Alabama, 35249, United States

  • Artiva Investigational Site Charlotte

    Charlotte, North Carolina, 28625, United States

  • Artiva Investigational Site Iowa

    Iowa City, Iowa, 52242, United States

  • Artiva Investigational Site Mesquite

    Mesquite, Texas, 75150, United States

  • Artiva Investigational Site Plantation

    Plantation, Florida, 33324, United States

  • Artiva Investigational Site San Diego

    San Diego, California, 92121, United States

  • Artiva Investigational Site Tucson

    Tucson, Arizona, 85724, United States

  • Artiva Investigational Site Woodlands

    The Woodlands, Texas, 77382, United States

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