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Trial record 1 of 1 for:    NCT06265220
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AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT06265220
Recruitment Status : Recruiting
First Posted : February 20, 2024
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Artiva Biotherapeutics, Inc.

Study Description
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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.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. 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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis - WHO Class III Lupus Nephritis - WHO Class IV Drug: AB-101 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 24, 2024
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1: Dose confirmation of AB-101 as Monotherapy Drug: AB-101
NK Cell Therapy

Drug: Cyclophosphamide
Lymphodepleting chemotherapy

Drug: Fludarabine
Lymphodepleting chemotherapy
Experimental: Phase 1: Dose confirmation of AB-101 plus Rituximab combination Drug: AB-101
NK Cell Therapy

Drug: Cyclophosphamide
Lymphodepleting chemotherapy

Drug: Fludarabine
Lymphodepleting chemotherapy

Drug: Rituximab
Anti-CD20 antibody therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Incidence, severity and causality of adverse events and serious adverse events

  2. AB-101 Clinical Activity [ Time Frame: From the time of first dose through 104 weeks after initiation of study treatment ]
    Determined by Overall Renal Response Rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with biopsy proven lupus nephritis Class III or IV either with or without the presence of Class V according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, who failed or did not respond to previous standard of care treatment approaches
  • A kidney biopsy must be performed < 24 weeks prior to the screening visit or during the screening period.
  • Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices.
  • Eligible subjects must have detectable anti-double stranded DNA antibody titers for enrollment.

Exclusion Criteria:

  • Known past or current malignancy other than inclusion diagnosis
  • Known clinically significant cardiac disease
  • Known past or current clinically significant lung disease, including:
  • Current use of tobacco products
  • Subjects with a history of HBV infections are considered ineligible
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06265220


Contacts
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Contact: AB-101-03 Study Team 858-377-8306 AB-101-03StudyTeam@ArtivaBio.com

Locations
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United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92121
Contact: Bosco Trinh         
Principal Investigator: Bethany Karl, DO         
Sponsors and Collaborators
Artiva Biotherapeutics, Inc.
Investigators
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Study Director: Sudhir Borgonha, MD Artiva Biotherapeutics
More Information
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Responsible Party: Artiva Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06265220    
Other Study ID Numbers: AB-101-03
First Posted: February 20, 2024    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Cyclophosphamide
Rituximab
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological