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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

NCT07544225

Not Yet RecruitingPhase 1

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Conditions: Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM)

Interventions: anti-CD19 CAR-T cells

Countries: France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Villejuif, Val de Marne, France