Phase IIa Trial of Anti-CD19 CAR T-Cells in Systemic Sclerosis Resistant to Immunosuppressive Therapy

Recruiting now · Phase 2

Conditions studied: Scleroderma, Systemic

In brief

The goal of this clinical trial is to evaluate whether anti-CD19 CAR T-cell therapy can improve disease activity in adults with severe, treatment-resistant systemic sclerosis (SSc). The study will also assess the safety of this therapy and how CAR T-cells behave in the body. The main questions are: Does CAR T-cell therapy reduce skin thickening and other signs of SSc? What side effects occur after receiving CAR T-cells? How do CAR T-cells expand, persist, and affect B-cells and autoantibodies? Participants will: Undergo leukapheresis Receive short lymphodepleting chemotherapy Receive one infusion of anti-CD19 CAR T-cells Stay in the hospital for about 10 days Attend follow-up visits for 24 months with clinical exams, blood tests, and organ-function assessments Optional skin or lymph-node biopsies may be performed in participants who consent to these procedures. This study aims to provide early evidence on whether CAR T-cell therapy could become a promising treatment option for systemic sclerosis.

Key facts

Study ID

NCT07493395

Run by

University Hospital, Montpellier

People needed

6

Starts

2026-06-11

Expected to finish

2028-06-11

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate organ functions assessed:
• serum Creatinine clearance > 40ml/mi
• adequate bone marrow function (Hemoglobin ≥9g/dL ; PMN ≥ 1 G/L ; Platelets ≥ 100 G/L)
• Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin < 2.0 mg/dL (34 μmol/L) (or < 3.0 mg/dL [51 μmol/L] for subjects with Gilbert's syndrome)
• Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation >/= 92% on room air
• Adequate venous access for apheresis
• Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)
• Leucapheresis : at least 12 weeks after biotherapy (i.e. tocilizumab, 6 months for rituximab),

You may not qualify if…

• Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
• ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%
• Lung and / or heart severe dysfunction defined by CVF<50% and/or DLCO <40%
• Pulmonary arterial hypertension defined by catheterism (mean AP > 25mmHg at rest or > 30mmHg after exercise, PAOP < 15mmHG)
• Clinically significant active, opportunistic, chronic or recurrent infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months including active or latent tuberculosis (TB) infection
• Contra indication for autologous hematopoietic stem cell transplantation (AHSCT ) or relapsing at least one year after AHSCT
• Active hematological or solid neoplasm
• Concurrent therapy with systemic steroids (>10 mg/d prednisone equivalent) within 2 weeks prior to inclusion, except inhaled steroids
• Methylprednisolone or prednisone (maximum dose 20 mg) instead of immunosuppressive agents
• T cell targeting drugs (e.g. mycophenolate mofetil, azathioprine, calcineurin inhibitors) within 6 weeks prior to leukapheresis
• Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy
• Live vaccines within 6 weeks prior to leukapheresis
• Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication/salvage therapies for treatment related toxicities
• patients without social security coverage;
• patients under guardianship;
• Male or female patients seeking to conceive a child
• Women of childbearing potential unless they are using a highly effective method of contraception starting from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells, and sexually active male participants unwilling to use a condom. Female partners of sexually active male participants must be on a highly effective form of birth control from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells.
• pregnant or breastfeeding women;
• patients with advanced cognitive disorders or any other cause preventing their informed consent;
• active, clinically significant CNS pathology : If signs or symptoms exist which present diagnostic uncertainty, neurologist consultation will be obtained to confirm the diagnosis of any neurological condition
• any comorbidity, whatever it may be, which may, in the opinion of the investigator, place the patient at additional risk or interfere with the monitoring of the study.
• Concurrent participation in any other interventional trial and Contraindication to the lymphodepleting chemotherapy

Where it is running

• Montpellier University Hospital — Montpellier, France (enrolling)
• CHRU Lille — Lille, France
• APHP Necker — Paris, France
• Chu Rouen — Rouen, France

Full record on ClinicalTrials.gov

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