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

Running, not enrolling · Phase 1

Conditions studied: Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE

In brief

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.

Key facts

Study ID

NCT06265220

Run by

Artiva Biotherapeutics, Inc.

People needed

51

Starts

2024-04-03

Expected to finish

2027-08-01

Last updated by the study team

2025-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Artiva Investigational Site Birmingham — Birmingham, Alabama, United States
• Artiva Investigational Site Tucson — Tucson, Arizona, United States
• Artiva Investigational Site San Diego — San Diego, California, United States
• Artiva Investigational Site Aventura — Aventura, Florida, United States
• Artiva Investigational Site Plantation — Plantation, Florida, United States
• Artiva Investigational Site Iowa — Iowa City, Iowa, United States
• Artiva Investigational Site Charlotte — Charlotte, North Carolina, United States
• Artiva Investigational Site Mesquite — Mesquite, Texas, United States
• Artiva Investigational Site Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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