Systemic Lupus ErythematosusPhase 1/2CASTLENCT06347718
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
A Phase 1/2 study testing anti-CD19 CAR T cell therapy in people with Systemic Lupus Erythematosus and Systemic Sclerosis, run by Miltenyi Biomedicine GmbH at 1 site in Germany.
Trial summary
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis
- What is being tested?
- anti-CD19 CAR T cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jul 2023to 31 May 2026
- 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
- General:
- Subjects must understand and voluntarily sign an informed consent form including written consent for data protection,
- Adults aged ≥ 18 years at time of consent,
- Adequate renal (eGFR > 30 ml/min/m2), liver (no Child Pugh C), heart (at worst NYHA III, EF > 30%) and pulmonary (FV and DLCO > 30%) function,
- Male subjects unless surgically sterile, must agree to use two acceptable methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP,
- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl in-dex <1) starting from the time of signing the ICF and for 12 months after dosing of the IMP,
Show all 24Show fewer
- Must be able to adhere to the study visit schedule and other protocol requirements,
- Double vaccination against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.
- SLE specific:
- Fulfilling the 2019 ACR/EULAR classification criteria of SLE,
- Positivity of anti-dsDNA (> 4 U/l), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more),
- Active disease at screening, defined as ≥ 1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥ 2 organ systems with a BILAG B score (moderate disease activity),
- Insufficient response or intolerance/ contraindication to glucocorticoids and to at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab, cyclophosphamide. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.
- SSc specific:
- Fulfilling the 2013 ACR/EULAR classification criteria of SSc),
- Positivity (+ or more) for at least one SSc-specific parameter (Scl70, RNA polymerase, Th/To, RP11/12, U3RNP autoantibodies),
- Signs for fast progression including (i) disease duration ≤ 5 years (from onset of first non-Raynaud manifestation), (ii) mRSS score 10-35 at screening, (iii) elevated acute phase reactant levels (CRP ≥ 6 mg/L, ESR ≥ 28mm/h or platelet count ≥ 330 G/L), (iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥ 1 tendon friction rub over 6 months,
- Insufficient response or intolerance/ contraindication to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.
- DM/PM specific:
- Fulfilling the 2017 ACR/EULAR classification criteria for probable or definite DM or PM,
- Presence of active myositis in muscle biopsy or muscle MRI and/or signs of interstitial lung disease related to DM/PM,
- Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma),
- Muscle weakness as define by MMT < 142 and 2 of the following criteria: VAS patients Global ≥2cm, VAS physician Global ≥ 2cm, HAQ > 0.25, at least one muscle enzyme > 1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2cm,
- Insufficient response or intolerance/ contraindication to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, intravenous immunoglobulins. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.
Who cannot join
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator
- ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl, absolute CD3+ T cell count < 100/μl,
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,
- Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study,
- Prior treatment with anti-CD19 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy),
Show all 17Show fewer
- History of bone marrow/ hematopoietic stem cell or solid organ transplantation,
- Any concomitant severe active infection, e.g. HIV, hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment,
- Diagnosis of severe neuropsychiatric SLE, inclusion body myositis or limited SSc,
- Pregnant or lactating females,
- Females who are intending to conceive during the study,
- Known hypersensitivity to any drug components,
- Malignancy in the last 5 years before screening,
- Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,
- Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent,
- Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results,
- Subjects who possibly are dependent on the Sponsor, the Principal Investigator or other Investigators (e.g. family members).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Georg Schett, Prof. Dr.
Daniela Bohr, Dr.
About this study
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.
- Being tested
- anti-CD19 CAR T cell therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Dermatomyositis, Polymyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR T cell therapyDrug
Single-dose
| Study group | Role | What they receive |
|---|---|---|
| Active dose | Other | A prospective, open-label, non-randomized, single-dose interventional basket study.
Single intravenous infusion of a freshly prepared advanced therapy medicinal product (ATMP) from autologous and expanded T cells transduced ex vivo with a CD19-CAR construct.
No control intervention (e.g. another immunosuppressive therapy). Concomitant measures: Leukapheresis and lymphodepleting therapy for conditioning. Receives: Drug: anti-CD19 CAR T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM).
Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell-associated neurotoxicity (ICANS) within the first 4 weeks after ATMP administration.
Measured: up to d 28
Secondary outcomes (15)
Clinical efficacy SSc
Overall Response Rate (ORR) at week 24 measured by specific disease activity composite indexes, each of them validated for the specific disease:
SSc: No progression of interstitial lung disease with worsening of FVC1 (>10 percentage) or worsening of FVC1 (5-10 percentage) plus increase in respiratory symptoms or worsening of FVC1 (5-10 percentage) plus progression of high-resolution computed tomography changes after 24 weeks.
Measured: at week 24
Clinical efficacy SLE
Overall Response Rate (ORR) at week 24 measured by specific disease activity composite indexes, each of them validated for the specific disease:
SLE: Fulfillment of DORIS remission criteria of SLE at week 24.
Measured: at week 24
Clinical efficacy DM
Overall Response Rate (ORR) at week 24 measured by specific disease activity composite indexes, each of them validated for the specific disease:
DM: 2016 ACR/EULAR moderate or major response.
Measured: at week 24
Cellular response
- amount of CAR T cells in the peripheral blood (cells/µl)
- amount of B cells in the peripheral blood (cells/µl)
- expansion of CAR T cells in the patient over time in cells/µl
Measured: up to week 24
Serological response
Levels of respective serum autoantibodies at week 24 including incidence of sero-conversion measured in IE/ml
- SLE: ANA-Titer, anti-dsDNA, anti-nucleosomes, anti-Sm, anti-cardiolipin IgG, C3 (mg/dl), C4 (mg/dl)
- SSc: ANA-Titer, anti-SCL70, anti-RNA polymerase III, anti-topoisomerase
- DM: ANA-Titer, anti-Mi2, anti-Tif1, anti-MDA5, anti-Jo1, anti-NXP2
Measured: up to week 24
Success of IMP process
Success of the manufacturing process by GMP certification of the product (in percentage)
Measured: up to week 24
Physicians Global Assessment to measure quality of life
Physician's Global Assessment (PhGA) of disease activity (VAS 0-100mm), (0=no disease activity, 100=worst disease activity)
Measured: up to week 24
Patient's Global Assessment to measure quality of life
Patient's Global Assessment (PtGA) of disease activity (VAS 0-100mm), (0=no disease activity, 100=worst disease activity)
Measured: up to week 24
Health Assessment Questionnaire
Disease Index HAQ-DI (0-4 per question; 0=best function, 4=worst function)
Measured: up to week 24
Functional Assessment of Chronic Illness Therapy
Fatigue with FACIT Fatigue questionaire, from 8-44, (8=worst, 44=best, serious fatigue defined <30)
Measured: up to week 24
SLE-specific disease activity over time per subject
British Isles Lupus Assessment Group (BILAG) index Improvement of organ involvement according to BILAG A-E (A=severe organ involvement, E=mild organ involvement)
Measured: up to week 24
SSc-specific disease activity over time per subject
modified Rodnan Skin Score (mRSS) points 0-4 according to skin stiffness (0=no thickening, 3=severe thickening)
Measured: up to week 24
DM/PM-specific disease activity over time per subject
Physician's global assessment (PhGA) of extramuscular activity 0-100mm (0=no disease activity, 100=worst disease activity)
Measured: up to week 24
SLE-specific disease activity over time per subject
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) points 1-8 according to organ involvement 1=mild organ involvement, 8=severe organ involvement)
Measured: up to 24 weeks
DM/PM-specific disease activity over time per subject
Manual Muscle Testing (MMT) points 0-150 (0=paraplegia, 150=full muscle strength)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start17 Jul 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1: Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patients Phase 2: Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Schett, Prof. Dr. med. univ., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347718
- Sponsor's protocol ID
- CASTLE
- Other IDs
- 2022-001366-35, DRKS00032279
- Acronym
- CASTLE
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2023
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rius Rigau A, Xu M, Liu Z, Chenguiti Fakhouri S, Auth J, Garantziotis P, Zoli A, Selvaraju MK, Raimondo MG, Tur C, Filla T, Gehringer P, Eckstein M, Muller F, Atzinger A, Ronicke M, Ekici A, Schmid R, Wirsching A, Hagen M, Boltz S, Krickau T, Horch RE, Berking C, Grieshaber-Bouyer R, Ramming A, Gupta P, Bozec A, Mackensen A, Distler JH, Schett G, Li YN, Bergmann C. Deep phenotyping of skin tissue remodeling in patients with systemic sclerosis treated with CD19-CAR T cells. Nat Commun. 2026 May 23;17(1):4640. doi: 10.1038/s41467-026-72817-7.
PubMed 42177178Muller F, Hagen M, Wirsching A, Kharboutli S, Aigner M, Volkl S, Kretschmann S, Tascilar K, Taubmann J, Bucci L, Raimondo MG, Bergmann C, Rothe T, Corte G, Tur C, Munoz L, Boltz S, Schuster L, Hartmann F, Garantziotis P, Sporl S, Vasova I, Gerbitz A, Spriewald B, Kiener H, Giannarelli D, Locatelli F, D'Agostino MA, Hanssens L, Miltenyi S, Bozec A, Grieshaber-Bouyer R, Mackensen A, Schett G. CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial. Nat Med. 2026 Mar;32(3):1142-1151. doi: 10.1038/s41591-025-04185-6. Epub 2026 Jan 7.
PubMed 41501497
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
- ClinicalTrials.gov ID
- NCT06347718
- Acronym / sponsor ID
- CASTLE / CASTLE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Apr 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.
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patients Phase 2: Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients
| Arm | Type | Receives |
|---|---|---|
| Active dose | Other | Drug: anti-CD19 CAR T cell therapyA prospective, open-label, non-randomized, single-dose interventional basket study. Single intravenous infusion of a freshly prepared advanced therapy medicinal product (ATMP) from autologous and expanded T cells transduced ex vivo with a CD19-CAR construct. No control intervention (e.g. another immunosuppressive therapy). Concomitant measures: Leukapheresis and lymphodepleting therapy for conditioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- General:
- SLE specific:
- SSc specific:
- DM/PM specific:
Key exclusion criteria (17 listed)
- Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator
- ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl, absolute CD3+ T cell count < 100/μl,
- Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,
- Severely impaired renal (eGFR ≤ 30 ml/min/m2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study,
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 |
|---|---|---|
| anti-CD19 CAR T cell therapySingle-dose | Drug | Active dose |
Primary outcome
To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM).
Time frame: up to d 28
Incidence and grading of severity (graded 0-4) of Cytokine Release Syndrome (CRS) and of CAR T cell-associated neurotoxicity (ICANS) within the first 4 weeks after ATMP administration.
15 secondary outcomes
Clinical efficacy SSc
Time frame: at week 24
Clinical efficacy SLE
Time frame: at week 24
Clinical efficacy DM
Time frame: at week 24
Cellular response
Time frame: up to week 24
Serological response
Time frame: up to week 24
Success of IMP process
Time frame: up to week 24
Physicians Global Assessment to measure quality of life
Time frame: up to week 24
Patient's Global Assessment to measure quality of life
Time frame: up to week 24
Health Assessment Questionnaire
Time frame: up to week 24
Functional Assessment of Chronic Illness Therapy
Time frame: up to week 24
SLE-specific disease activity over time per subject
Time frame: up to week 24
SSc-specific disease activity over time per subject
Time frame: up to week 24
DM/PM-specific disease activity over time per subject
Time frame: up to week 24
SLE-specific disease activity over time per subject
Time frame: up to 24 weeks
DM/PM-specific disease activity over time per subject
Time frame: up to 24 weeks
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 30 Sep 2025.
- Derived from this study: PubMed 42177178Rius Rigau A, Xu M, Liu Z, Chenguiti Fakhouri S, Auth J, Garantziotis P, Zoli A, Selvaraju MK, Raimondo MG, Tur C, Filla T, Gehringer P, Eckstein M, Muller F, Atzinger A, Ronicke M, Ekici A, Schmid R, Wirsching A, Hagen M, Boltz S, Krickau T, Horch RE, Berking C, Grieshaber-Bouyer R, Ramming A, Gupta P, Bozec A, Mackensen A, Distler JH, Schett G, Li YN, Bergmann C. Deep phenotyping of skin tissue remodeling in patients with systemic sclerosis treated with CD19-CAR T cells. Nat Commun. 2026 May 23;17(1):4640. doi: 10.1038/s41467-026-72817-7.
- Derived from this study: PubMed 41501497Muller F, Hagen M, Wirsching A, Kharboutli S, Aigner M, Volkl S, Kretschmann S, Tascilar K, Taubmann J, Bucci L, Raimondo MG, Bergmann C, Rothe T, Corte G, Tur C, Munoz L, Boltz S, Schuster L, Hartmann F, Garantziotis P, Sporl S, Vasova I, Gerbitz A, Spriewald B, Kiener H, Giannarelli D, Locatelli F, D'Agostino MA, Hanssens L, Miltenyi S, Bozec A, Grieshaber-Bouyer R, Mackensen A, Schett G. CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial. Nat Med. 2026 Mar;32(3):1142-1151. doi: 10.1038/s41591-025-04185-6. Epub 2026 Jan 7.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
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. med. univ. principal investigator
University of Erlangen-Nürnberg
1 site 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 anti-CD19 CAR T cell therapy in people with Systemic Lupus Erythematosus and Systemic Sclerosis, run by Miltenyi Biomedicine GmbH at 1 site 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 24 inclusion and 17 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 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Georg Schett, Prof. Dr. med. univ. (+49 9131 85 32093, georg.schett@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM). (time frame: up to d 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06347718, which also lists 2 linked publications.
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 30 Sep 2025.