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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Artiva Biotherapeutics, Inc.
Study ID
NCT06265220
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Lupus Nephritis - WHO Class III
  • Lupus Nephritis - WHO Class IV
  • Refractory Systemic Lupus Erythematosus
  • SLE

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AB-101 — DRUG
    NK Cell Therapy
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy
  • Fludarabine — DRUG
    Lymphodepleting chemotherapy
  • Rituximab — DRUG
    Anti-CD20 antibody therapy
  • Obinutuzumab — DRUG
    Anti-CD20 antibody therapy

Study Details

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.

Key Dates

Start date
Apr 3, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: From the time of consent through 104 weeks after initiation of study treatment ]

Locations (9)

FacilityCityStateZIPSite coordinators
Artiva Investigational Site BirminghamBirminghamAlabama35249-
Artiva Investigational Site TucsonTucsonArizona85724-
Artiva Investigational Site San DiegoSan DiegoCalifornia92121-
Artiva Investigational Site AventuraAventuraFlorida33180-
Artiva Investigational Site PlantationPlantationFlorida33324-
Artiva Investigational Site IowaIowa CityIowa52242-
Artiva Investigational Site CharlotteCharlotteNorth Carolina28625-
Artiva Investigational Site MesquiteMesquiteTexas75150-
Artiva Investigational Site WoodlandsThe WoodlandsTexas77382-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Artiva Investigational· Birmingham, ALArtiva Investigational· Tucson, AZArtiva Investigational Site San Diego· San Diego, CAArtiva Investigational· Aventura, FLArtiva Investigational· Plantation, FLArtiva Investigational· Iowa City, IA

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