for people ages 18-99 (full criteria)
at San Diego, California and other locations
study started
completion around
Principal Investigator
by Bethany Karl, DO



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.

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


Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, Nephritis, Lupus Nephritis, Systemic Lupus Erythematosus, Cyclophosphamide, Rituximab, Fludarabine, Obinutuzumab


You can join if…

Open to people ages 18-99

for Lupus Nephritis:

  • Adult subjects with biopsy proven lupus nephritis Class III or IV either with or without the presence of Class V according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, who failed or did not respond to previous standard of care treatment approaches
  • A kidney biopsy must be performed < 24 weeks prior to the screening visit or during the screening period.
  • Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices.
  • Eligible subjects must have detectable anti-double stranded DNA antibody titers for enrollment.

Inclusion Criteria for Refractory Systemic Lupus Erythematosus:

  • Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria
  • Total SLE Disease Activity Index (SELENA-SLEDAI score) >8 sat screening
  • Failed at least 12 weeks of 2 conventional therapies for SLE

You CAN'T join if...

  • Known past or current malignancy other than protocol stipulated low grade cancers, or curable cancer in complete response for >2 years
  • Known clinically significant cardiac disease
  • Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
  • Subjects with known active viral infections or, if with a history of HBV or HCV infections, have a viral load above the institution's limit of quantitation


  • University of California, San Diego accepting new patients
    San Diego California 92121 United States
  • University of Alabama at Birmingham (UAB) accepting new patients
    Birmingham Alabama 35294 United States

Lead Scientist at UCSD


accepting new patients
Start Date
Completion Date
Artiva Biotherapeutics, Inc.
Phase 1 Lupus Research Study
Study Type
Expecting 51 study participants
Last Updated