AB-101 + B-cell Depleting mAb for Lupus Nephritis
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves specific treatments like AB-101 and B-cell depleting antibodies, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for detailed guidance.
What data supports the effectiveness of the drug AB-101 + B-cell Depleting mAb for Lupus Nephritis?
B-cell depletion has been used successfully in treating other autoimmune diseases like rheumatoid arthritis, and some small studies have shown positive results for lupus nephritis. However, large trials with rituximab, a B-cell depleting drug, did not meet their main goals for lupus nephritis, indicating mixed results.12345
How is the drug AB-101 + B-cell Depleting mAb different from other lupus nephritis treatments?
AB-101 (AlloNK) combined with a B-cell depleting monoclonal antibody (mAb) is unique because it targets both natural killer (NK) cells and B cells, which are central to the disease process in lupus nephritis. This dual approach may offer a novel mechanism compared to traditional treatments that primarily focus on B-cell depletion alone.12467
Research Team
Sudhir Borgonha, MD
Principal Investigator
Artiva Biotherapeutics
Eligibility Criteria
This trial is for adults with Class III or IV lupus nephritis, a serious kidney condition caused by lupus, who haven't improved with standard treatments. Participants may also have Class V lupus nephritis. They must be able to receive the study medications and follow-up assessments.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive at least 1 cycle of AB-101, with the option for a second cycle spaced 24 weeks apart, in combination with a B-cell depleting mAb or as monotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AB-101 (Cell Therapy)
- Rituximab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Artiva Biotherapeutics, Inc.
Lead Sponsor