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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
AB-101
2018
Completed Early Phase 1
~10
Cyclophosphamide
2010
Completed Phase 4
~2310
Rituximab
1999
Completed Phase 4
~2990
Fludarabine
2012
Completed Phase 4
~1860

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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