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New treatment option for SLE - Systemic Lupus Erythematosus
Official title MB-CART19.1 in Refractory SLE
ClinicalTrials.gov ID: NCT06189157
What this study is testing
What is MB-CART19.1?
MB-CART19.1 is an investigational medicine, being studied as a potential treatment for sle - systemic lupus erythematosus.
Also referred to as CD19-targeting CAR T cells, Anti-CD19 CAR T cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients at least 18 years of age.
- Signed and dated informed consent before the conduct of any trial-specific procedure.
- SLE fulfilling the 2019 ACR/EULAR classification criteria (refer to Appendix 8).
- One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab...
- SLE with major organ involvement defined as either:
You likely can't join if
- Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular...
- Uncontrolled diabetes mellitus.
- Therapy induced lung disease and tuberculosis.
- Forced Vital Capacity (FVC) \< 60 %, FEV1 \< 60 %, Total Lung Capacity (TLC) \< 60 % and DLCO (diffusion capacity) \< 60 %.
- BILAG A or BILAG B for neuropsychiatric SLE.
- History of a malignancy unless disease free for ≥ 5 years with the exception of basal or squamous cell skin cancer.
See the full eligibility criteria
- Patients at least 18 years of age.
- Signed and dated informed consent before the conduct of any trial-specific procedure.
- SLE fulfilling the 2019 ACR/EULAR classification criteria (refer to Appendix 8).
- One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab, anifrolumab, methotrexate, azathioprine.
- SLE with major organ involvement defined as either:
- Presence of active lupus nephritis according to the following criteria:
- Histology proven class III or IV lupus nephritis according to ISN/RPS 2003 classification
- Urine protein-to-creatinine ratio (UPCR) \>1 in 24-hour urine collection
- Glomerular filtration rate (eGFR) of ≥30 mL/min/1.73 m2
- No history of kidney transplantation.
- Lupus with heart involvement (e.g., myocarditis, pericarditis, endocarditis) as measured by MRI or echocardiography/ultrasound.
- Lupus with pulmonary involvement (Lupus pleuritis, pulmonary arterial hypertension (PAH)) or lung disease defined as:
- Forced Vital Capacity (FVC) ≥ 60 % OR
- Forced Expiratory Volume (FEV1) ≥ 60 %,Total Lung Capacity (TLC) ≥ 60 %, DLCO (diffusion capacity) ≥ 60 % (according to ATS/ERS guidelines).
- Absolute CD3+ T cell count ≥ 100/µl.
- No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential. people must agree to use a contraceptive method from screening until 12 months after the...
- Fully vaccinated against SARS-CoV-2 according to the recommendations of RKI or confirmed SARS-CoV-2 infection within the last 6 months.
- Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis).
- Uncontrolled diabetes mellitus.
- Therapy induced lung disease and tuberculosis.
- Forced Vital Capacity (FVC) \< 60 %, FEV1 \< 60 %, Total Lung Capacity (TLC) \< 60 % and DLCO (diffusion capacity) \< 60 %.
- BILAG A or BILAG B for neuropsychiatric SLE.
- History of a malignancy unless disease free for ≥ 5 years with the exception of basal or squamous cell skin cancer.
- Cardiac function: Unstable coronary heart disease; left ventricular ejection fraction (LVEF) \< 50 %; no active myocarditis.
- Renal function: eGFR \< 30 ml/min/1.73 m2.
- Liver function: Severe hepatic insufficiency defined as a Child-Pugh score \> 10(C) (Appendix 10).
- Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive).
- Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative.
- Any active, uncontrolled bacterial, viral or fungal infection including SARS-CoV-2.
- History of hematopoietic stem cell or solid organ transplantation.
- Irreversible organ damage.
- Medications:
- Systemic corticosteroids \>10 mg within 7 days prior to leukapheresis;
- T cell targeting drugs (e.g., mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis;
- Prior treatment with anti-CD19 therapy;
- Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy;
- Live vaccines within 30 days prior to leukapheresis;
- Current cytotoxic drugs.
- 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...
- Contraindication of trial related procedures as judged by the investigator.
- Women of childbearing potential (WOCBP) who do not agree to use highly effective contraceptive measures (Pearl index \< 1) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only...
- Men with non-pregnant WOCBP partners who do not agree to use highly effective contraceptive measures (Pearl index \< 1, e.g. spermicide and condom or other highly effective contraceptive measures (Pearl index \< 1)...
- Concurrent participation in any other treatment trial.
- Inability to understand the procedures and risks associated with the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Germany
- Magdeburg, Germany
- Tübingen, Germany
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Germany; Magdeburg, Germany; Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.