Assistance Publique Hopitaux De Marseille
Marseille, France
RecruitingSystemic sclerodermaRheumatoid arthritis
Study of AlloNK and rituximab with cyclophosphamide and fludarabine in adults with relapsing rheumatoid arthritis, inflammatory myopathies, systemic sclerosis, or Sjögren's disease
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on several rheumatologic diseases, including Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, and Sjögren's Disease. The research evaluates a new treatment approach combining AlloNK (natural killer cells derived from umbilical cord blood) with rituximab (a medication that targets specific immune cells) in patients whose conditions have not responded well to standard treatments.
Before receiving the main treatment, patients will undergo preparation with two medications: cyclophosphamide and fludarabine, which help reduce certain immune cells in the body. The purpose of this study is to determine if this combination treatment is safe and if it can help improve symptoms in patients with these hard-to-treat rheumatic conditions.
The treatment involves receiving the medications through intravenous infusion (delivery directly into a vein). Patients will receive multiple doses of the study medications over several weeks and will be monitored regularly to check how well the treatment works and to watch for any side effects. The study will track various measurements of disease activity and symptoms specific to each condition to determine if the treatment is effective.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
25 criteria
- Age 18 years or older
- Must be able to understand and provide written consent for the study
- Must be willing to follow study procedures
- Must use effective contraception methods during the trial and for 1 year after treatment:
- For women: hormonal contraception, intrauterine devices, tubal ligation, or abstinence
- For men: vasectomy, barrier methods, or abstinence
- Must have adequate lung function with DLCO (lung capacity test) ≥ 60% and FVC (breathing capacity) ≥ 70%
- Heart function must show LVEF (pumping strength) ≥ 45% with no fluid around the heart
- Must have acceptable blood test results including:
- Adequate white blood cell count
- Adequate platelet count
- Adequate hemoglobin levels
- Adequate kidney function
- Acceptable liver function tests
- For patients with Rheumatoid Arthritis:
- Must meet specific diagnostic criteria
- Must have positive blood tests for RF or ACPA
- Must have active joint inflammation
- Must have tried and failed previous treatments
- For patients with Inflammatory Muscle Disease:
- Must meet specific diagnostic criteria
- Must have specific antibodies in blood
- Must have tried and failed previous treatments
- For patients with Systemic Sclerosis:
- Must meet specific diagnostic criteria
- Must have skin involvement and organ problems
- Symptoms must have started within last 3 years
- For patients with Sjögren's Disease:
- Must meet specific diagnostic criteria
- Must have active disease symptoms
- Must have adequate saliva production
Who cannot join the trial?
14 criteria
- History of allergic reactions to rituximab (a medication used to treat certain autoimmune conditions)
- Active or chronic infections, including:
- Hepatitis B (liver infection)
- Hepatitis C (liver infection)
- HIV (human immunodeficiency virus)
- Tuberculosis (bacterial infection affecting lungs)
- Severe heart conditions or uncontrolled high blood pressure
- Active cancer or history of cancer in the past 5 years (except successfully treated skin cancer)
- Pregnant or breastfeeding women
- Severe kidney or liver problems
- Mental health conditions that could affect ability to provide informed consent
- Participation in other clinical trials within the past 30 days
- Use of live vaccines (vaccines containing weakened but living forms of viruses or bacteria) within 4 weeks before study start
- Substance abuse or alcohol dependency within the past year
- Inability to follow study procedures or attend required visits
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Verified sites
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Verified Verified Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, ItalyResponsive University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria
Trial locations
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Investigated drugs
AlloNK
is an innovative cell therapy derived from cord blood NK cells (Natural Killer cells). It is designed to help treat patients with B-cell dependent rheumatologic diseases by targeting abnormal B cells in the immune system.
Rituximab
is an antibody medication that targets specific B cells in the immune system. It is commonly used to treat various autoimmune conditions and works by reducing the number of B cells that may be causing inflammation.
Cyclophosphamide
is a medication used for lymphodepletion (reducing the number of lymphocytes in the body). It helps prepare the patient's immune system before receiving the cell therapy treatment.
Fludarabine
is also used for lymphodepletion and works together with cyclophosphamide. This medication helps create space in the immune system for the new cell therapy to work more effectively.
What is already known about the treatment
Rituximab
A targeted biological medication administered through intravenous infusion that belongs to the class of monoclonal antibodies. It works by specifically targeting and destroying B-cells (a type of white blood cell) that carry the CD20 protein on their surface, making it effective in treating various autoimmune conditions including rheumatoid arthritis and other B-cell dependent rheumatologic diseases. This medication is well-established in medical practice with extensive clinical evidence supporting its use in both rheumatologic and oncologic conditions.
Cyclophosphamide
An immunosuppressive medication administered either orally or intravenously that belongs to the alkylating agent class of drugs. It works by interfering with DNA replication in rapidly dividing cells, particularly affecting immune system cells, and is commonly used in combination with other treatments for various autoimmune conditions and as part of lymphodepletion protocols. This medication has a long history of use in medical practice and is considered a standard treatment option in severe autoimmune diseases.
Fludarabine
A chemotherapy medication administered intravenously that belongs to the class of purine analogs. It works by interfering with DNA synthesis in lymphocytes, making it effective for lymphodepletion protocols and is often used in combination with other medications to prepare patients for cellular therapies. This medication is well-documented in medical literature and is commonly used in hematologic conditions and as part of preparative regimens.
AlloNK
An investigational cell therapy product derived from cord blood natural killer (NK) cells, administered intravenously. It represents an innovative approach to treating autoimmune conditions by utilizing the immune-modulating properties of allogeneic NK cells, and is being studied in combination with rituximab for treating B-cell dependent rheumatologic diseases. This therapy is currently in Phase 2a clinical trials to evaluate its safety and efficacy in patients with various rheumatologic conditions.
Investigated diseases
Rheumatoid Arthritis (RA)
A chronic inflammatory condition that affects multiple joints throughout the body. The immune system attacks the joint lining, causing swelling, stiffness, and pain. Over time, this inflammation can lead to joint damage and deformity. The condition typically affects joints symmetrically on both sides of the body.
Idiopathic Inflammatory Myopathies (IIMs)
A group of disorders causing muscle inflammation of unknown origin. These conditions lead to progressive muscle weakness, primarily affecting the muscles closest to the trunk of the body. Patients experience difficulty with basic movements such as climbing stairs, rising from chairs, or lifting objects.
Systemic Sclerosis (SSc)
A connective tissue disorder characterized by hardening and tightening of the skin and internal organs. The condition causes the body to produce too much collagen, leading to tissue thickening. It can affect multiple body systems, including the skin, blood vessels, and internal organs.
Sjögren's Disease (SjD)
An autoimmune disorder that primarily affects the moisture-producing glands. The condition typically causes dry eyes and dry mouth, but can also affect other parts of the body. The immune system attacks healthy tissue, particularly the glands that produce tears and saliva.
Ongoing clinical trials in Systemic scleroderma
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- Substances:Bi 10155501-[[(5R)-2-[4-(5-Chloro-2-Pyrimidinyl)-1-Piperidinyl]-6,7- Dihydro-5-Oxidothieno[3,2-D]Pyrimidin-4- Yl]Amino]-Cyclobutanemethanol
Countries:Austria
Austria- Participants:18–64 years · 65+ years
- Substances:Bi 1015550
- Sponsor:Boehringer Ingelheim Espana S.A.
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A study to evaluate the safety and effectiveness of QEL-005 in patients with diffuse cutaneous systemic sclerosis and difficult to treat rheumatoid arthritis
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- Disease:Systemic sclerodermaRheumatoid arthritis
- Substances:–
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Germany
Germany- Participants:18–64 years · 65+ years
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A long-term safety study of KYV-101 in patients previously treated for lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome
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Using 68Ga-FAPI-46 imaging to detect fibrosis in patients with inflammatory diseases such as Crohn's disease, ulcerative colitis, systemic sclerosis, and lung fibrosis.
Investigational
- Disease:Systemic sclerodermaColitis ulcerative+4
- Substances:(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate
Countries:
The Netherlands
The Netherlands- Participants:18–64 years · 65+ years
- Substances:(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate
- Sponsor:Amsterdam UMC Stichting
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520461-41-00Protocol codeAB-101-05Estimated enrolment127 patientsSponsorArtiva Biotherapeutics Inc.
sourced from the EU Clinical Trials Register and site verification
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