Actively Recruiting
Open-label Study to Evaluate Safety and Efficacy of Rituximab and AB-101 Combination in B-cell Associated Autoimmune Diseases
Led by IRIS Research and Development, LLC · Updated on 2024-09-03
30
Participants Needed
1
Research Sites
74 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
Researchers are evaluating the safety and activity of AB-101 combined with rituximab in adults with B-cell associated autoimmune diseases where rituximab is approved or recommended. These diseases include Rheumatoid Arthritis, Pemphigus Vulgaris, Granulomatosis with polyangiitis or microscopic polyangiitis, and Systemic Lupus Erythematosus. The study is a Phase 1, open-label trial conducted by IRIS Research and Development, LLC to explore this combination treatment. Participants will receive one cycle of treatment tailored to their specific condition. For Rheumatoid Arthritis, Pemphigus Vulgaris, or Systemic Lupus Erythematosus, treatment includes fludarabine on Days 1-3, cyclophosphamide on Day 3, rituximab on Days 1 and 15, and AB-101 NK cells on Days 6, 13, and 20. For Granulomatosis with polyangiitis or microscopic polyangiitis, rituximab is given on Days -2, 6, 13, and 20 with the other drugs on the same schedule. AB-101 is administered at least 48 hours after the last lymphodepletion infusion. Participants will be monitored for adverse events, serious adverse events, and hospitalizations from consent through 104 weeks after treatment starts. Disease activity scores specific to each condition will be evaluated at Weeks 12 and 24 to assess changes. Safety and efficacy assessments include laboratory tests, clinical evaluations, and disease activity indices. The total participation may extend over two years to capture long-term safety and treatment effects.
CONDITIONS
Brief 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 aged 18 years or older at consent
- Ability to understand and comply with study requirements
- Willingness to provide written informed consent
- Use of two acceptable contraception methods if of childbearing potential
- Oral steroids tapered to less than 20 mg/day prednisone or equivalent before treatment
- Predicted lung function: DLCO > 60% and FEV1 > 70% at screening
- Left ventricular ejection fraction ≥ 45% by echocardiogram
- Adequate hematologic, renal, and hepatic function per protocol
- Specific diagnosis and disease activity criteria for Rheumatoid Arthritis, Pemphigus Vulgaris, GPA/MPA, or Systemic Lupus Erythematosus
- Stable doses of required standard therapies prior to first study treatment
You will not qualify if you...
- Cyclophosphamide treatment within 3 months prior to study
- Laboratory values outside protocol-defined ranges unless deemed safe
- Known hypersensitivity or contraindication to study drugs
- History of anaphylactic reaction to relevant agents
- Prior B-cell targeted therapy within 3 months before lymphodepletion
- Previous genetically modified immune cell therapy
- Immunoglobulin replacement therapy or plasmapheresis within 6 months
- History of major organ or stem cell transplant
- Past or current malignancy except certain low-risk cancers
- History of B-cell malignancy
- Significant cardiac disease or unstable conditions
- Unresolved toxicities from prior therapy
- Uncontrolled acute or chronic diseases that increase risk
- Recent illness, infection, or vaccination within 6 weeks
- Drug or alcohol abuse within 1 year prior to Day 1
- HIV infection
- Pregnancy or lactation
- Conditions interfering with safety or study compliance
- Severe disease progression within 2 weeks of treatment
- Clinically significant lung disease or poor pulmonary function
- History of tobacco exposure ≥ 5 pack years or current tobacco use
- History of hypogammaglobulinemia or recent IVIG use
- Disease-specific exclusions such as other rheumatologic diseases, active skin lesions interfering with study, multi-system autoimmune diseases, drug-induced lupus, or severe antiphospholipid syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive one cycle of combination treatment with Rituximab, AB-101, Fludarabine, and Cyclophosphamide. Depending on their specific autoimmune disease, dosing schedules vary with multiple infusions and cell administrations occurring between Day -2 and Day 20.
Multiple visits including infusions on Days -2, 1, 2, 3, 6, 13, 15, and 20
Duration - Up to 104 weeks
Participants are monitored for safety and efficacy outcomes including adverse events and disease activity for up to 104 weeks after treatment initiation.
Periodic visits over 2 years for safety and efficacy assessments
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.
J
Jhon Galindo, B.S.
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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