Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anti-CD19 CAR-T cells.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).
Interventions
- Biological anti-CD19 CAR-T cells
The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight
Primary outcome measures
- Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion [Time frame: from CAR-T cells infusion to 30 days post-treatment]
Eligibility criteria
Inclusion criteria
- Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance > 30 mL/min)
Exclusion criteria
- Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF < 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Gustave Roussy — Villejuif
Identifiers
NCT: NCT07544225 · 2026-526552-32-00 · 2026/4318