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
Purpose
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.
Conditions
- Lupus Nephritis - WHO Class III
- Lupus Nephritis - WHO Class IV
- Refractory Systemic Lupus Erythematosus
- SLE
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
for all subjects (Lupus Nephritis or SLE) - 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. Inclusion Criteria for LN: - 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 Inclusion Criteria for SLE: - 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1: Dose confirmation of AB-101 as Monotherapy |
|
|
|
Experimental Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination |
|
|
|
Experimental Phase 1: Dose confirmation of AB-101 plus Rituximab combination |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35249
Tucson 5318313, Arizona 5551752 85724
San Diego 5391811, California 5332921 92121
Aventura 4146429, Florida 4155751 33180
Plantation 4168782, Florida 4155751 33324
Iowa City 4862034, Iowa 4862182 52242
Charlotte 4460243, North Carolina 4482348 28625
Mesquite 4710826, Texas 4736286 75150
The Woodlands 4736476, Texas 4736286 77382
More Details
- NCT ID
- NCT06265220
- Status
- Recruiting
- Sponsor
- Artiva Biotherapeutics, Inc.