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
Public ClinicalTrials.gov record NCT06265220. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06265220
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- AB-101 Drug
- Cyclophosphamide Drug
- Fludarabine Drug
- Rituximab Drug
- Obinutuzumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2024 (Actual)
- Primary completion
- Aug 2027 (Estimated)
- Completion
- Aug 2027 (Estimated)
- Last update posted
- Dec 10, 2025
2024 – 2027
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Artiva Investigational Site Birmingham | Birmingham | Alabama | 35249 | — |
| Artiva Investigational Site Tucson | Tucson | Arizona | 85724 | — |
| Artiva Investigational Site San Diego | San Diego | California | 92121 | — |
| Artiva Investigational Site Aventura | Aventura | Florida | 33180 | — |
| Artiva Investigational Site Plantation | Plantation | Florida | 33324 | — |
| Artiva Investigational Site Iowa | Iowa City | Iowa | 52242 | — |
| Artiva Investigational Site Charlotte | Charlotte | North Carolina | 28625 | — |
| Artiva Investigational Site Mesquite | Mesquite | Texas | 75150 | — |
| Artiva Investigational Site Woodlands | The Woodlands | Texas | 77382 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06265220, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06265220 live on ClinicalTrials.gov.