Actively Recruiting
Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-04-11
8
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM/PM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.
CONDITIONS
Official Title
Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must understand and voluntarily sign informed consent, including data protection consent
- Adults aged 18 years and older but younger than 65 years at consent
- Males must agree to use two contraception methods from consent until 12 months post-treatment unless surgically sterile
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception from consent until 12 months post-treatment
- Able to comply with study visit schedule and requirements
- Double vaccinated against SARS-CoV-2 or vaccinated within the last 6 months
- For SLE: meet 2019 ACR/EULAR criteria, presence of specific autoantibodies, active disease with defined severity, and insufficient response to glucocorticoids plus at least two specified treatments
- For SSc: meet 2013 ACR/EULAR criteria, diffuse SSc with autoantibody profile, signs of fast progression, and insufficient response to glucocorticoids plus at least two specified treatments
- For DM/PM: meet 2017 ACR/EULAR criteria, muscle weakness and related symptoms, presence of myositis-specific antibody, and insufficient response to glucocorticoids plus at least two specified treatments
- For AAV: meet 2022 ACR/EULAR criteria, presence of ANCA antibodies, disease activity criteria on BVAS, and failure of at least one specified treatment
You will not qualify if you...
- Suitable for less burdensome or approved treatments as judged by investigator
- Low blood counts: ANC < 1000/mm3, ALC < 500/mm3, hemoglobin < 8 g/dl, CD3+ T cells ≤ 100/µl
- Significant uncontrolled diseases affecting compliance or data interpretation
- Relevant cardiovascular disease including recent serious heart events or low heart function
- Conditions or lab abnormalities posing unacceptable risk or confounding data
- Impaired kidney function with eGFR < 30 ml/min
- Advanced fibrotic lung disease with low lung function
- Severe active infections including HIV, active hepatitis B or C, COVID-19, or tuberculosis
- Pregnancy or breastfeeding
- Known allergies to study drugs or lymphodepletion agents
- Cancer within past 5 years except fully resected carcinoma in situ
- Previous CAR T-cell therapy
- Incompatible treatment schedules or medications
- Participation in other investigational trials or recent experimental T or B cell affecting therapy
- Need for live vaccine during study or shortly before leukapheresis
- Under 18 years or unable to consent
- Recent alcohol or substance abuse affecting safety or data
- Dependence on study personnel
- For SLE patients: history of severe central nervous system involvement
- Patients with overlapping connective diseases or mixed connective tissue disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
Research Team
M
Maria Antonietta D'Agostino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here