Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06581562 · ClinicalTrials.gov registry record · Phase 1
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
A Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by IRIS Research and Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06581562: Recruiting Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by IRIS Research and Development.
NCT06581562 is a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that is actively recruiting participants, run by IRIS Research and Development. The registered enrollment target is 30 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06581562, a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by IRIS Research and Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
We will evaluate the Incidence of adverse events and relationship to study drug
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG AB-101
Study Locations (1)
Florida
- IRIS Research and Development, LLC - Plantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT06581562 shows while recruiting
NCT06581562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06581562 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06581562 about?
NCT06581562 is a clinical study titled "Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.". 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)...
What is the current status of trial NCT06581562?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-15. Estimated completion is 2028-12.
What conditions does trial NCT06581562 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Granulomatosis With Polyangiitis, Pemphigus Vulgaris.
What interventions are being tested in trial NCT06581562?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), AB-101 (DRUG).
Who is sponsoring clinical trial NCT06581562?
This trial is sponsored by IRIS Research and Development, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06581562 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06581562's enrollment target sits among peer trials
30 162nd of 197 higher than 34 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
RECRUITING · Phase 1
-
Study of GS-0151 in Participants With Rheumatoid Arthritis
RECRUITING · Phase 1
-
MAD Study of IA-14069
RECRUITING · Phase 1
-
A Study of AZD0120 in Autoimmune Diseases
RECRUITING · Phase 1
-
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
RECRUITING · Phase 1
-
Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI