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AB-101 + Rituximab for Autoimmune Diseases (IRIS-RD-01 Trial)

Phase 1

Recruiting

Led By Guillermo J. Valenzuela, M.D.

Research Sponsored by IRIS Research and Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline laboratory values fulfilling the specified requirements to demonstrate adequate hematologic, renal, and hepatic function

Women of childbearing potential and all male participants must agree to use two acceptable methods of contraception together to avoid pregnancy

Must not have

Severe disease progression or health deterioration within specified timeframe

Known past or current clinically significant lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 through 24

Awards & highlights

Summary

This trial will test the safety and effectiveness of AB-101 combined with rituximab in treating B-cell related autoimmune diseases like Rheumatoid Arthritis, Pemphigus Vulgaris

Who is the study for?

This trial is for individuals with autoimmune diseases like Pemphigus, Lupus, Rheumatoid Arthritis, and Granulomatosis where B-cells are involved. Participants must have a condition where Rituximab is approved or recommended.

What is being tested?

The study tests the combination of AB-101 with Rituximab against autoimmune diseases affecting B-cells. It's an open-label trial at a single center to assess if this combo improves patient outcomes.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression such as increased infection risk, infusion-related reactions from Rituximab, and potential toxicity from Cyclophosphamide and Fludarabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, kidney, and liver tests meet the required levels.

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I agree to use two forms of birth control if I can have children.

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My lung function tests show my breathing is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My health has significantly worsened recently.

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I have a history of serious lung disease.

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My lung condition does not meet the trial's requirements.

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I have had a major organ or bone marrow transplant.

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I have had cancer before, but it fits the exceptions listed.

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I still have side effects from previous cancer treatments.

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My autoimmune disease affects my lungs and breathing.

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I have had a condition where lymphocytes are produced in excessive amounts.

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I have a history of cancer.

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I have a history of low immune proteins or low IgG levels.

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I don't have any severe, uncontrolled health issues unrelated to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 through 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 through 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 through 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Serious Adverse Events (SAE) and causality assessment

Incidence of adverse events and relationship to study drug

Total hospitalizations, duration of hospitalizations through the course of the study

Secondary study objectives

GPA / MPA: Change from baseline in the Birmingham Vasculitis Activity Score at Week 12 and 24

PV: Change from baseline in the Pemphigus Disease Area Index (PDAI) at Week 12 and 24

RA: Change From Baseline in DAS28 at Week 12 and 24

+1 more

Other study objectives

Patient Reported Outcomes

Pharmacodynamic Biomarkers

Pharmacokinetics and Immunogenicity

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4Experimental Treatment4 Interventions

Arm 4- Subjects with Granulomatosis with polyangiitis / microscopic polyangiitis

Group II: Arm 3Experimental Treatment4 Interventions

Arm 3 - Systemic Lupus Erythematosus

Group III: Arm 2Experimental Treatment4 Interventions

Arm 2- Pemphigus Vulgaris

Group IV: Arm 1Experimental Treatment4 Interventions

Arm 1 - Subjects with Rheumatoid Arthritis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2200

AB-101

2018

Completed Early Phase 1

~10

Cyclophosphamide

2010

Completed Phase 4

~2320

Fludarabine

2012

Completed Phase 4

~1860

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Artiva Biotherapeutics, Inc.Industry Sponsor

4 Previous Clinical Trials

446 Total Patients Enrolled

IRIS Research and Development, LLCLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Guillermo J. Valenzuela, M.D.Principal InvestigatorIRIS Research and Development, LLC

~20 spots leftby Jul 2027

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