SLE - Systemic Lupus ErythematosusPhase 1/2NCT06189157
MB-CART19.1 in Refractory SLE
A Phase 1/2 study testing MB-CART19.1 in people with SLE - Systemic Lupus Erythematosus, run by Miltenyi Biomedicine GmbH at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE - Systemic Lupus Erythematosus
- What is being tested?
- MB-CART19.1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesGermany
- Study dates
- 12 Aug 2024to 30 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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. Subjects must agree to use a contraceptive method from screening until 12 months after the administration of the IMP.
- Fully vaccinated against SARS-CoV-2 according to the recommendations of RKI or confirmed SARS-CoV-2 infection within the last 6 months.
Who cannot join
- 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.
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- 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 therapies for treatment related toxicities.
- 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 acceptable if it is in line with the preferred and usual life style of the participant) or have a vasectomised partner as the sole sexual partner (the vasectomised partner must have received medical assessment of the surgical success) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment.
- A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.
- Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion.
- Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.
- 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) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment.
- Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.
- Concurrent participation in any other interventional trial.
- Inability to understand the procedures and risks associated with the trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Erlangen, Medizinische Klinik 3
Erlangen
Georg Schett, Prof., Dr.
Fabian Müller, PD, Dr.
- Recruiting
Otto-von-Guericke-Universität Magdeburg
Magdeburg
Dimitrious Mougiakakos, Dr.
Eugen Feist, Prof., Dr.
- Recruiting
Universitatsklinikum Tubingen - Medizinische Universitätsklinik Abt. II
Tübingen
Jörg Henes, Prof., Dr.
Wolfgang Bethge, Prof., Dr.
About this study
Official title: An Open-label Phase I/IIa, Multicentre, Interventional Single-arm Trial of MB-CART19.1 in Patients With Refractory SLE
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.
In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.
Read the detailed description
Patients will be treated in cohorts of 3. After each cohort, the Safety Monitoring Board (SMB) will meet to assess whether the next higher dose level can be opened.
The follow-up of the patients will be performed in 3 steps:
- Until day 28 after treatment, the patients will be followed up closely by monitoring vital functions and lab parameters for signs of AEs and DLTs. Blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken. B cell aplasia in peripheral blood will be determined together with other secondary and exploratory biomarkers, response will be assessed and AEs will be documented.
- In the second follow-up phase until 1 year, blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken, B cell aplasia will be determined, response will be assessed and AEs will be documented until end of week 12, afterwards serious AEs (SAE) and AEs of special interest (AESI) will be documented, serious adverse reactions (SAR)/AESI will be reported.
- All patients irrespective of the clinical response will be followed up then for 1 more year or until the patient is lost to follow-up or has died. After completion of this last follow-up phase, patients will be rolled over to a subsequent follow-up observation for up to further 13 years.
- Conditions
- SLE - Systemic Lupus Erythematosus
- Being tested
- MB-CART19.1
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-CART19.1Biological
Also called CD19-targeting CAR T cells, Anti-CD19 CAR T cells
MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 0 | Experimental | Phase I: DL 0: 0,1x10e6 MB-CART19.1 cells Dose finding algorithm will start at dose level 1, with dose level 0 as a rescue dose. Receives: Biological: MB-CART19.1 |
| Dose Level 1 | Experimental | Phase I: DL 1: 0,5x10e6 MB-CART19.1 cells Patients will be treated in cohorts of 3. If no DLT is determined, the dose can be escalated. Receives: Biological: MB-CART19.1 |
| Dose Level 2 | Experimental | Phase I: DL 2: 1,0x10e6 MB-CART19.1 cells At the highest dose level 3 additional patients will be treated. Receives: Biological: MB-CART19.1 |
| Phase II - Recommended dose MB-CART19.1 | Experimental | Phase II will evaluate the efficacy and safety in patients treated with the recommended dose Receives: Biological: MB-CART19.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determination of the recommended dose for phase IIa out of 3 dose levels
Based on a Bayesian Optimal Interval (BOIN) design with DLT after infusion of MB-CART19.1
Measured: Until day 28 after infusion of MB-CART19.1
Phase I: Safety and toxicity of MB-CART19.1
Incidence of adverse event (AE), classified according to CTCAE version 5.0, and evaluation and classification of Cytokine Release Syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS)
Measured: 24 months
Phase IIa: Proportion of patients in remission after infusion of MB-CART19.1
Remission is evaluated by fulfillment of DORIS remission criteria of SLE
Measured: Month 6
Secondary outcomes (8)
Phase I and Phase IIa: Treatment response to MB-CART19.1
Measured by DORIS, LLDAS, SLEDAI 2K, BILAG
Measured: Day 28, Week 12, Month 6, Month 12, Month 24
Phase I and Phase IIa: Patient reported outcomes
SF-36, FACIT-F, HAQ-DI
Measured: Day 0, Day 28, Week 12, Month 6, Month 12, Month 24
Phase I and Phase IIa: Cellular and humoral immunogenicity
Incidence of cellular and humoral immunogenicity
Measured: Day 28, Week 12, Month 6, Month 12
Phase I and Phase IIa: B cell aplasia and immunoglobulin deficiency
Occurrence and duration of B cell aplasia, immunoglobulin levels
Measured: Day 0, all visits after Day 7 inclusive until Month 24
Phase I and Phase IIa: Levels of immunology parameters
Changes in the levels of SLE associated serum autoantibodies, C3/C4, lupus anticoagulant
Measured: Screening, Lymphodepletion, Day 0, Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 24
Phase I and Phase IIa: Persistence of MB-CART19.1
Percentage of MB-CART19.1 of all T cells as well as total number of MB-CART19.1 in peripheral blood
Measured: All visits after Day 2 inclusive until Month 24
Phase I and Phase IIa: Immunophenotyping of circulating immune cells
Percentage of circulating immune cells and B-cell subsets measured by flow cytometry
Measured: All visits starting from Day 0 inclusive
Phase I and Phase IIa: Serum cytokines and BAFF
Cytokine levels in peripheral blood
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start12 Aug 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE - Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Schett, Prof. Dr., Principal investigator, University Clinical Erlangen, Medical Clinic 3
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189157
- Sponsor's protocol ID
- M-2022-398
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I/IIa, Multicentre, Interventional Single-arm Trial of MB-CART19.1 in Patients With Refractory SLE
- ClinicalTrials.gov ID
- NCT06189157
- Acronym / sponsor ID
- M-2022-398
- Conditions
- SLE - Systemic Lupus Erythematosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.
Detailed description
Patients will be treated in cohorts of 3. After each cohort, the Safety Monitoring Board (SMB) will meet to assess whether the next higher dose level can be opened.
The follow-up of the patients will be performed in 3 steps:
- Until day 28 after treatment, the patients will be followed up closely by monitoring vital functions and lab parameters for signs of AEs and DLTs. Blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken. B cell aplasia in peripheral blood will be determined together with other secondary and exploratory biomarkers, response will be assessed and AEs will be documented.
- In the second follow-up phase until 1 year, blood samples for the determination of persistence and phenotype of infused CAR+ cells will be taken, B cell aplasia will be determined, response will be assessed and AEs will be documented until end of week 12, afterwards serious AEs (SAE) and AEs of special interest (AESI) will be documented, serious adverse reactions (SAR)/AESI will be reported.
- All patients irrespective of the clinical response will be followed up then for 1 more year or until the patient is lost to follow-up or has died. After completion of this last follow-up phase, patients will be rolled over to a subsequent follow-up observation for up to further 13 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 0 | Experimental | Biological: MB-CART19.1Phase I: DL 0: 0,1x10e6 MB-CART19.1 cells Dose finding algorithm will start at dose level 1, with dose level 0 as a rescue dose. |
| Dose Level 1 | Experimental | Biological: MB-CART19.1Phase I: DL 1: 0,5x10e6 MB-CART19.1 cells Patients will be treated in cohorts of 3. If no DLT is determined, the dose can be escalated. |
| Dose Level 2 | Experimental | Biological: MB-CART19.1Phase I: DL 2: 1,0x10e6 MB-CART19.1 cells At the highest dose level 3 additional patients will be treated. |
| Phase II - Recommended dose MB-CART19.1 | Experimental | Biological: MB-CART19.1Phase II will evaluate the efficacy and safety in patients treated with the recommended dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-CART19.1Also: CD19-targeting CAR T cells, Anti-CD19 CAR T cellsMB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells | Biological | Dose Level 0, Dose Level 1, Dose Level 2, Phase II - Recommended dose MB-CART19.1 |
Primary outcome
Phase I: Determination of the recommended dose for phase IIa out of 3 dose levels
Time frame: Until day 28 after infusion of MB-CART19.1
Based on a Bayesian Optimal Interval (BOIN) design with DLT after infusion of MB-CART19.1
Phase I: Safety and toxicity of MB-CART19.1
Time frame: 24 months
Incidence of adverse event (AE), classified according to CTCAE version 5.0, and evaluation and classification of Cytokine Release Syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS)
Phase IIa: Proportion of patients in remission after infusion of MB-CART19.1
Time frame: Month 6
Remission is evaluated by fulfillment of DORIS remission criteria of SLE
8 secondary outcomes
Phase I and Phase IIa: Treatment response to MB-CART19.1
Time frame: Day 28, Week 12, Month 6, Month 12, Month 24
Phase I and Phase IIa: Patient reported outcomes
Time frame: Day 0, Day 28, Week 12, Month 6, Month 12, Month 24
Phase I and Phase IIa: Cellular and humoral immunogenicity
Time frame: Day 28, Week 12, Month 6, Month 12
Phase I and Phase IIa: B cell aplasia and immunoglobulin deficiency
Time frame: Day 0, all visits after Day 7 inclusive until Month 24
Phase I and Phase IIa: Levels of immunology parameters
Time frame: Screening, Lymphodepletion, Day 0, Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 24
Phase I and Phase IIa: Persistence of MB-CART19.1
Time frame: All visits after Day 2 inclusive until Month 24
Phase I and Phase IIa: Immunophenotyping of circulating immune cells
Time frame: All visits starting from Day 0 inclusive
Phase I and Phase IIa: Serum cytokines and BAFF
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georg Schett, Prof. Dr. principal investigator
University Clinical Erlangen, Medical Clinic 3
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MB-CART19.1 in people with SLE - Systemic Lupus Erythematosus, run by Miltenyi Biomedicine GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (+4922048306820, clinicaltrials.gov@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Determination of the recommended dose for phase IIa out of 3 dose levels (time frame: Until day 28 after infusion of MB-CART19.1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.