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New treatment option for Lupus Erythematosus, Systemic
Official title Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
ClinicalTrials.gov ID: NCT06685042
What this study is testing
What is CAR T cell?
CAR T cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus erythematosus, systemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- General
- people must understand and voluntarily sign an informed consent form, including written consent for data protection;
- Adults aged ≥ 18 years and \< 65 years at time of consent;
- Male people, unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and...
- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective...
You likely can't join if
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator;
- ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8 g/dl, absolute CD3+ T cell count ≤100/µl;
- Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
- Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia...
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the...
- Impaired renal function, i.e., eGFR \< 30 ml/min;
See the full eligibility criteria
Who can join
- General
- people must understand and voluntarily sign an informed consent form, including written consent for data protection;
- Adults aged ≥ 18 years and \< 65 years at time of consent;
- Male people, unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the...
- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \<1) starting from the time of signing the ICF...
- Must be able to adhere to the study visit schedule and other protocol requirements;
- Double vaccination (2 doses) against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.
- SLE people a) Fulfilling the 2019 ACR/EULAR classification criteria of SLE; b) Presence of anti-dsDNA, anti-histone, anti-nucleosome or anti-Sm antibodies; c) Active disease at screening, defined as ≥1 organ system with...
- SSc people
- Fulfilling the 2013 ACR/EULAR classification criteria of SSc;
- Diffuse SSc with respective autoantibody profile;
- Signs for fast progression including i) disease duration ≤5 years (from onset of first non-Raynaud manifestation), ii) mRSS score 10-35 at screening, iii) elevated acute phase reactant levels (CRP ≥ 6 mg/L, ESR ≥ 28mm/h...
- Insufficient response to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab.
- DM/PM people a) Fulfilling the 2017 ACR/EULAR classification criteria for probable or definite DM or PM57, b) Muscle weakness as defined by MMT \ 0.25, at least one muscle enzyme \>1.3 times upper limit of normal, VAS...
- AAV people
- Fulfilling the 2022 ACR/EULAR classification criteria for MPA/GPA/EGPA,
- Presence of ANCA to either proteinase 3 or myeloperoxidase;
- At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS;
- Failure of at least 1 of the following treatments: glucocorticoids, cyclophosphamide, or B-cell targeting therapy.
What rules you out
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator;
- ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8 g/dl, absolute CD3+ T cell count ≤100/µl;
- Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
- Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure, or left ventricular ejection fraction \< 50%...
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;
- Impaired renal function, i.e., eGFR \< 30 ml/min;
- Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) \< 40% of predicted or a Diffusing Capacity for Carbon...
- Any concomitant severe active infection, including HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody [HBcAb] or positive hepatitis B surface antigen [HBsAg] and NAT...
- Pregnant or lactating females;
- Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;
- Malignancy in the last 5 years before screening. The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed.
- Previous CAR T cell administration;
- A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1 of CSP) and the medications permitted during the study (section 7.11 of CSP);
- Concurrent treatment with other investigational agents or participation in other investigational trials.
- Treatment, as part of an investigational clinical trial, with an experimental product with a definite or potential effect on T or B-cells in the previous 2 years.
- Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis;
- people who are younger than 18 years or are incapable of understanding the aim, importance, and consequences of the study and giving legal informed consent;
- Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration or may...
- people who possibly are dependent on the Sponsor, the Principal Investigator, or the Investigator (e.g., family members).
- Limited to patients diagnosed with SLE: patients with a history of severe central nervous system (CNS) involvement, including those who have presented aseptic meningitis, cerebral vasculitis, cerebrovascular disease...
- Patients meeting the classification criteria for multiple connective diseases such as overlapping SLE and Sjogren's Syndrome (SS) or SLE and Rheumatoid Arthritis (RA) and patients diagnosed with Mixed Connective Tissue...
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.