NCT06265220Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 9 Feb 2024
- Start date
- 3 Apr 2024
- Primary completion date
- Aug 2027
- Lead sponsor
- Artiva Biotherapeutics, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06265220
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 51
- From 3 Apr 2024 to the primary completion date, Aug 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Severe active CNS Lupus
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Artiva Investigational Site Aventura Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Artiva Investigational Site Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Artiva Investigational Site Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Artiva Investigational Site Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Artiva Investigational Site Mesquite Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Artiva Investigational Site Plantation Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Artiva Investigational Site San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Artiva Investigational Site Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Artiva Investigational Site Tucson Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.