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
- Conditions
- Lupus Nephritis - WHO Class IIIRefractory Systemic Lupus ErythematosusLupus Nephritis - WHO Class IV
- Interventions
- Registration Number
- NCT06265220
- Lead Sponsor
- Artiva Biotherapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 51
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1: Dose confirmation of AB-101 as Monotherapy AB-101 - Phase 1: Dose confirmation of AB-101 plus Rituximab combination AB-101 - Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination AB-101 - Phase 1: Dose confirmation of AB-101 as Monotherapy Cyclophosphamide - Phase 1: Dose confirmation of AB-101 as Monotherapy Fludarabine - Phase 1: Dose confirmation of AB-101 plus Rituximab combination Cyclophosphamide - Phase 1: Dose confirmation of AB-101 plus Rituximab combination Fludarabine - Phase 1: Dose confirmation of AB-101 plus Rituximab combination Rituximab - Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination Fludarabine - Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination Cyclophosphamide - Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination Obinutuzumab -
- Primary Outcome Measures
Name Time Method AB-101 Clinical Activity From the time of first dose through 104 weeks after initiation of study treatment Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events From the time of consent through 104 weeks after initiation of study treatment Incidence, severity and causality of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
University of California, San Diego
🇺🇸San Diego, California, United States