2024-519511-33-00RecruitingPhase 2
A Phase IIa Trial Evaluating the Efficacy of anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs. SCLEROCAR
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Oct 2026
Brief summary (registry, in English)
To evaluate the clinical efficacy of the CAR T ANTI-CD19 cell therapy on skin fibrosis assessed by mRSS score month 6 after CAR T ANTI-CD19 cell administration in patients with systemic sclerosis resistant to immunosuppressive drugs.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 27 May 2025
- Start date
- 13 Oct 2026
- Lead sponsor
- Centre Hospitalier Universitaire De Montpellier
- Diseases
- Systemic sclerosis (scleroderma)
- EU CT number
- 2024-519511-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 6
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with systemic sclerosis that is still active or getting worse despite several immunosuppressive drugs.
- Age
- 18 to 65 years old
- Sex
- Men and women can join.
- Disease stage
- Systemic sclerosis diagnosed by the ACR/EULAR criteria, with active disease (EUSTAR 2.5 or higher) or a worsening disease despite 6 months of treatment.
- Earlier treatment
- Must have had at least 2 immunosuppressive treatments for 6 months, including one DMARD (methotrexate, azathioprine or mycophenolate mofetil) and one biological DMARD (rituximab or tocilizumab). Wash-out before leukapheresis: 6 weeks for conventional immunosuppressants, 3 months after tocilizumab, 6 months after rituximab.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Active infection, including hepatitis B or C virus, HIV, or covid-19 in the last month
- Active blood cancer or solid tumour
- Severe lung or heart problems, including pulmonary arterial hypertension
- Live vaccines within 30 days before leukapheresis
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Live vaccines within 30 days prior to leukapheresis
Other illness
- Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
- patients with advanced cognitive disorders or any other cause preventing their informed consent
- 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, PAPO < 15mmHG)
- Active infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months
Lab values
- ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%
Other
- pregnant or breastfeeding women
- Active hematological or solid neoplasm
- Methylprednisolone or prednisone (≤20 mg) instead of immunosuppressive agents
- Rituximab within 6 months to leukapheresis
Who the study is looking for
- Diagnosis of systemic sclerosis according to ACR/EULAR classification
- Refractory corresponds to patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab.
- Age: ≥18 ≤65 years old
- Adequate organ functions assessed within 4 weeks of inclusion:
- Adequate venous access for apheresis
- Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)
- Leucapheresis : at least 3 months after biotherapy (i.e. tocilizumab, 6 months for rituximab),
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Lille | Lille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Assistance Publique Hopitaux de Paris – Hopital Cochin | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.