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
NCT ID: NCT06265220
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
51 participants
INTERVENTIONAL
2024-04-03
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose confirmation of AB-101 as Monotherapy
AB-101
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination
AB-101
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Obinutuzumab
Anti-CD20 antibody therapy
Phase 1: Dose confirmation of AB-101 plus Rituximab combination
AB-101
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Rituximab
Anti-CD20 antibody therapy
Interventions
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AB-101
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Rituximab
Anti-CD20 antibody therapy
Obinutuzumab
Anti-CD20 antibody therapy
Eligibility Criteria
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Inclusion Criteria
* Subjects must have had an inadequate response with at least two prior lines of standard of care (SoC) treatment.
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Artiva Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Saddekni, M.D., PgDip, BCMAS
Role: STUDY_DIRECTOR
Artiva Biotherapeutics
Locations
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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
Countries
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Other Identifiers
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AB-101-03
Identifier Type: -
Identifier Source: org_study_id
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