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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
EU CTIS ID: 2024-519511-33-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
- pregnant or breastfeeding women
- patients with advanced cognitive disorders or any other cause preventing their informed consent
- 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, PAPO < 15mmHG)
See the full eligibility criteria
- 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),
- Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
- pregnant or breastfeeding women
- patients with advanced cognitive disorders or any other cause preventing their informed consent
- 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, PAPO < 15mmHG)
- Active infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months
- Active hematological or solid neoplasm
- Methylprednisolone or prednisone (≤20 mg) instead of immunosuppressive agents
- Rituximab within 6 months to leukapheresis
- Live vaccines within 30 days prior to leukapheresis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.