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 Recruiting Phase 1 DMC

• 2 other identifiers: 2026-526552-32-002026/4318
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion

  Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either: * Cytokine Release Syndrome (CRS) ≥ grade 3 or, * Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or, * Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3

  from CAR-T cells infusion to 30 days post-treatment

Study Arms (1)

Treatment

EXPERIMENTAL

The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight

Biological: anti-CD19 CAR-T cells

Interventions

anti-CD19 CAR-T cells BIOLOGICAL

The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Myositis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Cristina CASTILLA-LLORENTE

CONTACT

+33(0)142114355; Cristina.castilla-llorente@gustaveroussy.fr

Timothé DENAËS

CONTACT

+33(0)142115554; timothe.denaes@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2043
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)