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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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

Locations
United States
Alabama
Artiva Investigational Site Birmingham
RECRUITING
Birmingham
Arizona
Artiva Investigational Site Tucson
RECRUITING
Tucson
California
Artiva Investigational Site San Diego
RECRUITING
San Diego
Florida
Artiva Investigational Site Aventura
RECRUITING
Aventura
Artiva Investigational Site Plantation
RECRUITING
Plantation
Iowa
Artiva Investigational Site Iowa
RECRUITING
Iowa City
North Carolina
Artiva Investigational Site Charlotte
RECRUITING
Charlotte
Texas
Artiva Investigational Site Mesquite
RECRUITING
Mesquite
Artiva Investigational Site Woodlands
RECRUITING
The Woodlands
Contact Information
Primary
AB-101-03 Chanel Mansfield, MPH
clinicaltrials@artivabio.com
1 858 223 7001
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2027-08
Participants
Target number of participants: 51
Treatments
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
Sponsors
Leads: Artiva Biotherapeutics, Inc.

This content was sourced from clinicaltrials.gov