Actively Recruiting
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
Led by IRIS Research and Development, LLC · Updated on 2024-09-03
30
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
I
IRIS Research and Development, LLC
Lead Sponsor
A
Artiva Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.
CONDITIONS
Official Title
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years or older at consent
- Ability to understand and comply with study requirements
- Willingness to provide written informed consent
- Agreement to use two methods of contraception if of childbearing potential
- Oral steroids tapered to less than 20 mg/day prednisone or equivalent at least 1 week before treatment
- Lung function: DLCO > 60% and FEV1 > 70% at screening
- Heart function: LVEF ≥ 45% by echocardiogram
- Adequate blood counts and organ function per protocol requirements
- Specific diagnostic criteria and prior treatment failure for each disease: RA, PV, GPA/MPA, SLE
- Stable doses of standard-of-care therapies for specified durations prior to treatment
You will not qualify if you...
- Cyclophosphamide treatment within 3 months before study
- Laboratory values outside protocol range unless safe per investigator
- Known allergy to study drugs or components
- History of severe allergic reactions to related agents
- Prior B-cell targeted therapy within 3 months
- Prior gene-modified immune cell therapies
- Immunoglobulin replacement or plasmapheresis within 6 months
- History of major organ or stem cell transplant
- Past or current malignancies except certain low-risk types
- History of B-cell malignancy
- Significant recent cardiac disease or unstable conditions
- Unresolved toxicities from previous treatments
- Uncontrolled acute or chronic diseases not related to studied conditions
- Planned surgery or conditions making study participation unsuitable
- Recent illness, infection, or vaccination within 6 weeks
- Current or recent drug or alcohol abuse
- HIV infection
- Pregnancy or lactation
- Other conditions interfering with safety or study compliance
- Severe disease progression within 2 weeks prior to treatment
- Significant lung disease or pulmonary manifestations affecting function
- History of tobacco use ≥ 5 pack years or current tobacco use
- History of low immunoglobulin levels or recent IVIG treatment
- Disease-specific exclusions for RA, PV, GPA/MPA, and SLE as detailed in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRIS Research and Development, LLC
Plantation, Florida, United States, 33324
Actively Recruiting
Research Team
K
Kathy I Perez, M.D.
CONTACT
J
Jhon Galindo, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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